AcrySof™ IQ Vivity™ Extended Vision, Toric Extended Vision, Extended Vision UV Absorbing, and Toric Extended Vision UV A

P930014S126 · Alcon Laboratories, Inc. · POE · Feb 26, 2020 · Ophthalmic

Device Facts

Record IDP930014S126
Device NameAcrySof™ IQ Vivity™ Extended Vision, Toric Extended Vision, Extended Vision UV Absorbing, and Toric Extended Vision UV A
ApplicantAlcon Laboratories, Inc.
Product CodePOE · Ophthalmic
Decision DateFeb 26, 2020
DecisionAPPR
Regulation21 CFR 886.3600
Device ClassClass 3
AttributesTherapeutic

Indications for Use

The AcrySof™ IQ Vivity™ Extended Vision IOL Model DFT015 is indicated for primary implantation for the visual correction of aphakia in adult patients with < 1.00 D of preoperative corneal astigmatism, in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens mitigates the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, the lens provides improved intermediate and near visual acuity, while maintaining comparable distance visual acuity. The AcrySof™ IQ Vivity™ IOL is intended for capsular bag placement only. The AcrySof™ IQ Vivity™ Toric Extended Vision IOL Models DFT315, DFT415, and DFT515 are indicated for primary implantation for the visual correction of aphakia and for reduction of residual refractive astigmatism in adult patients with pre-existing corneal astigmatism, in whom a cataractous lens has been removed by extracapsular cataract extraction. The lenses mitigate the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, the lenses provide improved intermediate and near visual acuity, while maintaining comparable distance visual acuity. The AcrySof™ IQ Vivity™ Toric IOLs are intended for capsular bag placement only. The AcrySof™ IQ Vivity™ Extended Vision UV Absorbing IOL Model DAT015 is indicated for primary implantation for the visual correction of aphakia in adult patients with < 1.00 D of preoperative corneal astigmatism, in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens mitigates the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, the lens provides improved intermediate and near visual acuity, while maintaining comparable distance visual acuity. The AcrySof™ IQ Vivity™ UV Absorbing IOL is intended for capsular bag placement only. The AcrySof™ IQ Vivity™ Toric Extended Vision UV Absorbing IOL Models DAT315, DAT415, and DAT515 are indicated for primary implantation for the visual correction of aphakia and for reduction of residual refractive astigmatism in adult patients with pre-existing corneal astigmatism, in whom a cataractous lens has been removed by extracapsular cataract extraction. The lenses mitigate the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, the lens provides improved intermediate and near visual acuity, while maintaining comparable distance visual acuity. The AcrySof™ IQ Vivity™ Toric UV Absorbing IOLs are intended for capsular bag placement only.

Device Story

Foldable, single-piece posterior chamber intraocular lens (IOL) implanted during cataract surgery; replaces human crystalline lens. Features patented Wavefront-Shaping technology on anterior surface to provide extended depth of focus; negative spherical aberration to compensate for corneal aberration. Toric models include biconic posterior surface to correct astigmatism. Manufactured from high refractive index hydrophobic acrylic material; includes blue light filtering chromophore (DFT models) or UV-absorbing (DAT models). Delivered via qualified IOL delivery system (e.g., MONARCH) through small incision; unfolds in capsular bag. Surgeon uses web-based calculator for toric alignment. Provides improved intermediate/near vision compared to monofocal IOLs while maintaining distance acuity. Benefits include increased spectacle independence. Potential risks include reduced contrast sensitivity and visual disturbances (halos, starbursts).

Clinical Evidence

Prospective, multicenter, randomized, subject/assessor-masked study (n=220). Primary endpoints: non-inferiority in BCDVA, superiority in DCIVA, and depth of focus range. Results: Vivity met non-inferiority for BCDVA; superior in DCIVA (1.6 lines better) and DCNVA; depth of focus range 1.53D vs 0.99D (control). Safety: No unanticipated adverse events; cumulative/persistent serious AE rates below ISO 11979-7:2014 thresholds. Vivity showed reduced mesopic contrast sensitivity vs monofocal control.

Technological Characteristics

Hydrophobic acrylate/methacrylate copolymer IOL; 6.0mm optic diameter, 13.0mm overall length. Wavefront-Shaping anterior surface; biconic posterior surface (toric models). Refractive index 1.55. UV-absorbing; blue light filtering (DFT models). Foldable; STABLEFORCE modified-L haptics. Complies with ISO 11979-2, ISO 11979-3, and ANSI Z80.35-2018.

Indications for Use

Indicated for primary implantation in adult patients following extracapsular cataract extraction for visual correction of aphakia (with or without pre-existing corneal astigmatism) and mitigation of presbyopia via extended depth of focus. Toric models also reduce residual refractive astigmatism.

Regulatory Classification

Identification

An intraocular lens is a device made of materials such as glass or plastic intended to be implanted to replace the natural lens of an eye.

Predicate Devices

Reference Devices

Submission Summary (Full Text)

{0} # SUMMARY of SAFETY and EFFECTIVENESS DATA (SSED) ## I. GENERAL INFORMATION | Devices Generic Name: | Extended Depth of Focus Intraocular Lens | | --- | --- | | Devices trade name: | AcrySof™ IQ Vivity™ Extended Vision Intraocular Lens (Model DFT015) AcrySof™ IQ Vivity™ Toric Extended Vision IOLs (DFT315, DFT 415, DFT515) AcrySof™ IQ Vivity™ Extended Vision UV Absorbing IOL (DAT015) AcrySof™ IQ Vivity™ Toric Extended Vision UV Absorbing IOLs (DAT315, DAT415, DAT515) | | Device Procode: | POE | | Applicant's Name and Address: | Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, Texas 76134 | | Date of Panel recommendation: | None | | Premarket Approval Application (PMA) Number: | P930014/S126 | | Date of FDA Notice of Approval: | February 26, 2020 | The AcrySof™ IQ Vivity™ Extended Vision Intraocular Lens (Model DFT015) is based on the parent device AcrySof™ Natural Single-Piece Intraocular lens (IOL) Model SB30AL approved under the 180-day Supplement P930014/S009 on June 24, 2003, with the following Indications for Use: AcrySof™ Natural posterior chamber intraocular lenses are indicated for the replacement of the human lens to achieve visual correction of aphakia in adults when extracapsular cataract extraction or phacoemulsification are performed. These lenses are intended for placement in the capsular bag. The AcrySof™ IQ Vivity™ Extended Vision Ultraviolet (UV) Absorbing IOL (DAT015) is based on the parent device AcrySof™ Acrylic Single-Piece Foldable Posterior Chamber IOL Model SA30EL, approved under the 180-day Supplement P930014/S006 on September 20, 1999, with the following Indications for Use: PMA P930014/S126: FDA Summary of Safety and Effectiveness Data Page 1 {1} AcrySof™ posterior chamber intraocular lenses are indicated for the replacement of the human lens to achieve visual correction of aphakia in adult patients when extracapsular cataract extraction or phacoemulsification are performed. These lenses are intended for placement in the capsular bag. For the toric optical design, the AcrySof™ IQ Vivity™ Toric Extended Vision IOLs (DFT315, DFT 415, DFT515) and AcrySof™ IQ Vivity™ Toric Extended Vision UV Absorbing IOLs (DAT315, DAT415, DAT515) are based on the parent toric device AcrySof™ Toric (Models SA60T3-T5) under the Panel Track Supplement P930014/S015, approved on September 14, 2005 with the following Indications for Use: The AcrySof™ Toric posterior chamber intraocular lenses are intended for primary implantation in the capsular bag of the eye for visual correction of aphakia and pre-existing corneal astigmatism secondary to removal of a cataractous lens in adult patients with or without presbyopia, who desire improved uncorrected distance vision, reduction of residual refractive cylinder and increased spectacle independence for distance vision. The SSED to support the indication is available on the CDRH website and is incorporated by reference here. The current Panel Track Supplement was submitted to expand the indications and include the AcrySof™ IQ Vivity™ Extended Vision Intraocular Lens (Model DFT015), AcrySof™ IQ Vivity™ Toric Extended Vision IOLs (DFT315, DFT 415, DFT515), AcrySof™ IQ Vivity™ Extended Vision UV Absorbing IOL (DAT015), and the AcrySof™ IQ Vivity™ Toric Extended Vision UV Absorbing IOLs (DAT315, DAT415, DAT515) for an extended depth of focus indication. ## II. INDICATIONS FOR USE ### AcrySof™ IQ Vivity™ Extended Vision IOL The AcrySof™ IQ Vivity™ Extended Vision IOL Model DFT015 is indicated for primary implantation for the visual correction of aphakia in adult patients with < 1.00 D of preoperative corneal astigmatism, in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens mitigates the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, the lens provides improved intermediate and near visual acuity, while maintaining comparable distance visual acuity. The AcrySof™ IQ Vivity™ IOL is intended for capsular bag placement only. ### AcrySof™ IQ Vivity™ Toric Extended Vision IOLs The AcrySof™ IQ Vivity™ Toric Extended Vision IOL Models DFT315, DFT415, and DFT515 are indicated for primary implantation for the visual correction of aphakia and for reduction of residual refractive astigmatism in adult PMA P930014/S126: FDA Summary of Safety and Effectiveness Data Page 2 {2} patients with pre-existing corneal astigmatism, in whom a cataractous lens has been removed by extracapsular cataract extraction. The lenses mitigate the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, the lenses provide improved intermediate and near visual acuity, while maintaining comparable distance visual acuity. The AcrySof™ IQ Vivity™ Toric IOLs are intended for capsular bag placement only. # AcrySof™ IQ Vivity™ Extended Vision UV Absorbing IOL The AcrySof™ IQ Vivity™ Extended Vision UV Absorbing IOL Model DAT015 is indicated for primary implantation for the visual correction of aphakia in adult patients with < 1.00 D of preoperative corneal astigmatism, in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens mitigates the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, the lens provides improved intermediate and near visual acuity, while maintaining comparable distance visual acuity. The AcrySof™ IQ Vivity™ UV Absorbing IOL is intended for capsular bag placement only. # AcrySof™ IQ Vivity™ Toric Extended Vision UV Absorbing IOLs The AcrySof™ IQ Vivity™ Toric Extended Vision UV Absorbing IOL Models DAT315, DAT415, and DAT515 are indicated for primary implantation for the visual correction of aphakia and for reduction of residual refractive astigmatism in adult patients with pre-existing corneal astigmatism, in whom a cataractous lens has been removed by extracapsular cataract extraction. The lenses mitigate the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, the lens provides improved intermediate and near visual acuity, while maintaining comparable distance visual acuity. The AcrySof™ IQ Vivity™ Toric UV Absorbing IOLs are intended for capsular bag placement only. ### III. CONTRAINDICATIONS There are no known contraindications. ### IV. WARNINGS and PRECAUTIONS The warnings and precautions can be found in the AcrySof™ IQ Vivity™ Extended Vision Intraocular Lens labeling. ### V. DEVICE DESCRIPTION AcrySof™ IQ Vivity™ Extended Vision IOLs The non-diffractive AcrySof™ IQ Vivity™ Extended Vision Posterior Chamber Intraocular Lenses (IOLs) Model DFT015 and Toric Models DFT315, DFT415, and DFT515 are UV-absorbing and blue light filtering (BLF) foldable IOLs which, compared to a monofocal IOL, provide an extended depth of focus. The PMA P930014/S126: FDA Summary of Safety and Effectiveness Data Page 3 {3} AcrySof™ IQ Vivity™ Toric Extended Vision IOL models also compensate for corneal astigmatism. The single-piece design consists of a high refractive index hydrophobic acrylic material with proprietary blue light filtering chromophore, which filters light in a manner that approximates the human crystalline lens in the 400-475 nm blue light wavelength range (1). In addition to standard UV-light filtering, the blue-light filtering chromophore reduces transmittance of blue light wavelengths. The biconvex aspheric optic consists of a high refractive index soft acrylic material capable of being folded prior to insertion, allowing placement through an incision smaller than the optic diameter of the lens. The optic is 6.0 mm in diameter and the lens has an overall diameter of 13.0mm. After surgical insertion into the eye, the lens unfolds to restore its intended shape. The supporting haptics provide proper positioning and fixation of the IOL optic within the eye. The extended depth of focus is achieved through the patented Wavefront-Shaping technology located on the anterior surface of the IOL. The location of the Wavefront-Shaping optic is identical for all lens powers. The anterior surface of the AcrySof™ IQ Vivity™ Extended Vision IOL is also designed with negative spherical aberration to compensate for the positive spherical aberration of the cornea. The posterior surface of the Toric lens is biconic creating a toricity to correct the astigmatism on the cornea. The flat meridian of the AcrySof™ IQ Vivity™ Toric IOLs is identified with the indentations (dots; axis marks) on the posterior surface of the optic. Alignment of the toric IOL cylinder axis marks with the post-operative steep corneal meridian allows the lens to correct astigmatism. The physical characteristics of the AcrySof™ Vivity™ IOL are summarized in Figures 1, 2, and 3, as well as Table 1. The modulation transfer function (MTF) through-focus response of a Vivity IOL in a model eye using polychromatic light (white light) is depicted in Figure 4. # AcrySof™ IQ Vivity™ Extended Vision UV Absorbing IOLs The non-diffractive AcrySof™ IQ Vivity™ Extended Vision UV Absorbing Posterior Chamber IOLs Model DAT015 and Toric Models DAT315, DAT415, and DAT515 are UV-absorbing (UVA) foldable IOLs which, compared to a monofocal IOL, provide an extended depth of focus. The AcrySof™ IQ Vivity™ Toric Extended Vision UV Absorbing IOL models also compensate for corneal astigmatism. The biconvex aspheric optic consists of a high refractive index soft acrylic material capable of being folded prior to insertion, allowing placement through an incision smaller than the optic diameter of the lens. The optic is 6.0 mm in diameter and the lens has an overall diameter of 13.0mm. After surgical insertion into the eye, the lens unfolds to restore its intended shape. The supporting haptics provide proper positioning and fixation of the IOL optic within the eye. PMA P930014/S126: FDA Summary of Safety and Effectiveness Data Page 4 {4} The extended depth of focus is achieved through the patented Wavefront-Shaping technology located on the anterior surface of the IOL. The location of the Wavefront-Shaping optic is identical for all lens powers. The anterior surface of the AcrySof™ IQ Vivity™ Extended Vision UV Absorbing IOL is designed with negative spherical aberration to compensate for the positive spherical aberration of the cornea. The posterior surface of the Toric lens is biconic creating a toricity to correct the astigmatism on the cornea. The flat meridian of the AcrySof™ IQ Vivity™ Toric UV Absorbing IOLs is identified with the indentations (dots; axis marks) on the posterior surface of the optic. The physical characteristics of the AcrySof™ IQ Vivity™ IOL are summarized in Figures 1,2, and 3, as well as Table 1. The modulation transfer function (MTF) through-focus response of a Vivity™ IOL in a model eye using polychromatic light (white light) is depicted in Figure 4. Figure 1: Physical Characteristics of the AcrySof™ IQ Vivity™ IOL All dimensions in millimeters ![img-0.jpeg](img-0.jpeg) PMA P930014/S126: FDA Summary of Safety and Effectiveness Data Page 5 {5} Figure 2: Physical Characteristics of the AcrySof™ IQ Vivity™ Toric IOL All dimensions in millimeters ![img-1.jpeg](img-1.jpeg) Table 1: Physical Characteristics of AcrySof™ IQ Vivity™ IOLs | Characteristic | Model | | | | | --- | --- | --- | --- | --- | | | DFT015/ DAT015 | DFT315/ DAT315 | DFT415/ DAT415 | DFT515/ DAT515 | | Optic Type | Biconvex Wavefront- Shaping Optic | Biconvex toric Wavefront-Shaping Optic | | | | Optic / Haptic Material | DFT Models: Ultraviolet and blue light filtering hydrophobic Acrylate/Methacrylate Copolymer UV cutoff at 10% T: 401 nm (+20.0 diopter (D) lens) DAT Models: Ultraviolet filtering hydrophobic Acrylate/Methacrylate Copolymer UV cutoff at 10% T: 396 nm (+20.0 diopter lens) | | | | | Spherical Powers | +15.0 diopters – +25.0 diopters in 0.5 diopter increments | | | | | IOL Cylinder Power – IOL Plane (diopters) | N/A | 1.50 | 2.25 | 3.00 | | IOL Cylinder Power – Corneal Plane* (Diopters) | N/A | 1.03 | 1.55 | 2.06 | | Index of Refraction | 1.55 | | | | | Haptic Configuration | STABLEFORCE Modified-L Haptics | | | | | Optic Diameter (mm) Ø_{B} | 6.0 | | | | | Overall Length (mm) Ø_{T} | 13.0 | | | | | Haptic Angle | 0° | | | | *Based on the average pseudophakic human eye PMA P930014/S126: FDA Summary of Safety and Effectiveness Data Page 6 {6} Figure 3: Spectral Transmittance Top panel: AcrySof™ UV Absorbing (UVA); Lower panel: AcrySof™ BLF ![img-2.jpeg](img-2.jpeg) ![img-3.jpeg](img-3.jpeg) # NOTES: 1. The cutoff wavelength and the spectral transmittance curves presented here represent the range of transmittance values of IOLs made from hydrophobic acrylate/methacrylate copolymer with bonded UV-absorber (AcrySof™ UVA, Figure 3 upper panel) or IOLs made from hydrophobic acrylate/methacrylate copolymer with bonded UV-absorber and Alcon's proprietary blue light filtering chromophore (AcrySof™ BLF, Figure 3 lower panel). 2. Measurements were by direct transmittance using AcrySof™ IOLs with center thickness equivalent to the marketed range. 3. Human crystalline lens data is from Boettner and Wolter (1962) (1). PMA P930014/S126: FDA Summary of Safety and Effectiveness Data Page 7 {7} Figure 4: Modulation Transfer Function (MTF) Through-Focus Response of 20.0 D IOLs in a Model Eye (White Light, 50 lp/mm, 3 mm Aperture) ![img-4.jpeg](img-4.jpeg) An Alcon web-based calculator is used in conjunction with the AcrySof™ IQ Vivity™ Toric IOLs to determine the appropriate intraocular alignment and cylinder power for the patient. During standard cataract surgery and implantation of the AcrySof™ IQ Vivity™ IOL, an Alcon qualified delivery system and viscoelastic combination should be used. Alcon recommends using the qualified MONARCH® IOL Delivery System or any other Alcon qualified combination. Currently qualified combinations that can be used with these lenses are listed in Table 2. Table 2: Qualified Combinations of Compatible Products | Lens Model | Diopter Range | Cartridge | Handpiece | Ophthalmic Viscosurgical Device (OVD) | | --- | --- | --- | --- | --- | | DAT015/DFT015 | +15.0 to +25.0 | MONARCH™ III D (8065977763) | MONARCH™ III (blue) (8065977773) | VISCOAT™ OVD | | DAT315/DFT315 | | | | PROVISC™ OVD | | DAT415/DFT415 | | | | DISCOVISC™ OVD | | DAT515/DFT515 | | | | | ## VI. ALTERNATIVE PRACTICES AND PROCEDURES Patients who undergo cataract extraction presently have several non-surgical and surgical alternatives for restoring functional vision of the aphakic eye. Non-surgical options include special cataract glasses or contact lenses. Surgical options such as monofocal, multifocal, extended depth of focus or accommodative IOLs are also available. Each alternative has its own advantages and disadvantages. A patient should fully discuss these alternatives with his/her physician to select the method that best meets expectations and lifestyle. PMA P930014/S126: FDA Summary of Safety and Effectiveness Data Page 8 {8} ## **VII. MARKETING HISTORY** The AcrySof™ IQ Vivity™ IOLs are registered and commercialized in the European Union and Australia. The lenses have not been withdrawn from marketing for any reason related to safety and effectiveness. ## **VIII. POTENTIAL ADVERSE EFFECTS OF THE DEVICE ON HEALTH** Below is a list of the potential adverse effects (e.g., complications) associated with the use of the device: - lens epithelial cell down-growth - corneal endothelial damage - infection (endophthalmitis) - retinal detachment/tear - vitritis - cystoid macular edema - corneal edema - pupillary block - cyclitic membrane - iris prolapse - hypopyon - anterior uveitis - hyphema - pigment dispersion - posterior capsule opacification - transient or persistent glaucoma - IOL dislocation, tilt, or decentration requiring surgical repositioning - residual refractive error resulting in secondary surgical intervention - increased visual symptoms (compared to a monofocal IOL) related to the optical characteristics of the IOL, including reduction in contrast sensitivity Secondary surgical interventions include, but are not limited to: lens repositioning, lens replacement, vitreous aspiration, iridectomy for pupillary block, wound leak repair, and retinal detachment repair. For any specific adverse events that occurred in the clinical study, please see Section X below. ## **IX. SUMMARY OF NONCLINICAL STUDIES** Biocompatibility and chemical characterization were performed on the parent lenses and is incorporated by reference. These studies were conducted in accordance with International Standard Organization (ISO) 10993-1, Biological PMA P930014/S126: FDA Summary of Safety and Effectiveness Data Page 9 {9} evaluation of medical devices – Part 1: Evaluation and testing within a risk management process, and ISO 11979-5, Ophthalmic implants – Intraocular lenses – Part 5: Biocompatibility and relevant parts of ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. Studies were conducted in accordance with Good Laboratory Practices (GLP). ### Optical/Mechanical Testing Pre-clinical optical / mechanical tests were performed with the AcrySof™ IQ Vivity™ IOLs (Toric and non-Toric) manufactured from the AcrySof™ Natural material and were measured in accordance with ISO 11979-2 Ophthalmic Implants – Intraocular Lenses – Part 2: Optical Properties and Test Methods, ISO 11979-3 Ophthalmic Implants – Intraocular Lenses – Part 3: Mechanical Properties and Test Methods, and American National Standard (ANSI) for Ophthalmics Z80.35-2018: Extended Depth of Focus Intraocular Lenses. Test results are presented in Table 3. **Table 3: Optical and Mechanical Testing** | Test | Results | | --- | --- | | Clear Optic Diameter | Passed | | Optic Diameter | Passed | | Overall Diameter | Passed | | Vault Height | Passed | | Sagitta | Passed | | Optic Edge Thickness | Passed | | Recovery of Properties following Simulated Surgical Manipulation | Passed | | Spherical Dioptric Power | Passed | | Cylindrical Dioptric Power (Toric only) | Passed | | Imaging Quality | Passed | | MTF through-focus Response | Completed | | MTF testing with Tilt and Decentration | Completed | | Expected Visual Acuity | Completed | | Depth of Focus Range | Completed | ### **X. SUMMARY OF PIVOTAL CLINICAL STUDY** The applicant performed a clinical study to establish a reasonable assurance of the safety and effectiveness of the AcrySof™ IQ Vivity™ Extended Vision IOLs for the proposed indications. This study was conducted in the U.S. under investigational device exemption (IDE) G170175. Data from this clinical study were the basis for the PMA approval decision. A summary of the clinical study is presented below. PMA P930014/S126: FDA Summary of Safety and Effectiveness Data Page 10 {10} The AcrySof™ IQ Vivity™ Toric Extended Vision IOL models involved imposing the toric feature from the toric design parents onto the posterior surface of the AcrySof™ IQ Vivity™ Toric Extended Vision IOL models. Since the study for the AcrySof™ IQ Vivity™ Extended Vision IOL Model DFT015 established safety and the applicant has approved toric parent IOLs, additional clinical data was not required to support safety and effectiveness of the toric models, because the only difference is in cylinder powers. ### A. Study Design Subjects were treated between October 2017 and October 2018. The database for this Panel Track PMA Supplement reflected data collected through October 2018 and included 220 implanted subjects. There were 11 investigational sites in the U.S. A prospective, 6-month, multicenter, randomized, subject masked, vision-assessor masked, parallel-group study was designed to evaluate bilateral implantation a total of 220 subjects (110 bilaterally implanted subjects in each arm). This study was designed to evaluate the effectiveness and safety of the AcrySof™ IQ Vivity™ IOL (Model DFT015) in providing increased depth of focus and improved intermediate and near visual acuity, compared to the aspheric monofocal IOL, the AcrySof™ Monofocal IOL Model SN60WF. The monofocal control IOL is a legally-marketed alternative with similar indications for use, except that it is not intended to provide improved vision at intermediate and near distances. Statistical analyses were frequentist. A total of 220 subjects were planned for bilateral implantation in a randomized 1:1 ratio, in order to ensure that at least 200 eligible subjects (100 in each arm) completed the study. This sample size assumed a dropout rate of 10%, approximately. A brief description of the statistical assumptions used to perform the sample size calculations is presented in Table 4. **Table 4: Vivity Pivotal Study Sample Size Calculations** | | Margin | Expected Difference | SD | Type I error 1-sided | Power | | --- | --- | --- | --- | --- | --- | | **Non-Inferiority** | | | | | | | BCDVA | 0.10 | 0.04 | 0.16 | 5% | 84% | | **Superiority** | | | | | | | DCNVA (40 cm) | | 0.12 | 0.18 | 2.5% | 99% | | DCIVA (66 cm) | | 0.12 | 0.18 | 2.5% | 99% | | Spectacle need | | 25% | | 2.5% | 94% | PMA P930014/S126: FDA Summary of Safety and Effectiveness Data Page 11 {11} # 1. Clinical Inclusion and Exclusion Criteria Enrollment in the AcrySof™ IQ Vivity™ Extended Vision IOL study was limited to subjects who met the following inclusion criteria in both eyes: 1. Adults (22 years or older at the time of participation in the study) diagnosed with cataract in both eyes 2. Best-corrected distance visual acuity (BCDVA) of 0.3 logMAR (20/40 Snellen) or worse either with or without a glare source present (e.g., Brightness Acuity Tester). 3. Clear intraocular media other than cataract 4. Planned cataract removal by routine small incision surgery 5. Calculated lens power between 18.0 and 25.0 D [when targeted for emmetropia (0.00 D)] 6. Willing and able to complete all required postoperative visits 7. Able to comprehend and sign an IRB/IEC (Institutional Review Board/Independent Ethics Committee) approved statement of informed consent 8. Potential postoperative BCDVA of 0.2 logMAR (20/32 Snellen) or better in each eye based on Investigator's medical opinion 9. Preoperative keratometric astigmatism of less than 1.0 D in both operative eyes Subjects were not permitted to enroll in the AcrySof™ IQ Vivity™ Extended Vision IOL study if they, or either eye, met any of the following exclusion criteria: 1. Any disease or pathology, other than cataract, that (in the expert opinion of the Investigator) is expected to reduce the potential postoperative BCDVA to a level worse than 0.2 logMAR (including, but not limited to the following: amblyopia, clinically severe corneal dystrophy (e.g., epithelial, stromal, or endothelial dystrophy), diabetic retinopathy, extremely shallow anterior chamber, not due to swollen cataract, microphthalmos, previous retinal detachment, previous corneal transplant, recurrent severe anterior or posterior segment inflammation of unknown etiology, iris neovascularization, uncontrolled glaucoma, aniridia, or optic nerve atrophy, epiretinal membrane, macular degeneration, or diagnosis of pseudoexfoliation) 2. History of recurrent anterior segment/posterior segment inflammation. 3. Clinically significant (in the Investigator's opinion) corneal pathology (epithelial, stromal, endothelial) or ocular surface disease that would adversely affect the visual outcome including but not limited to old significant corneal scars (including Salzman's nodular degeneration), corneal irregularity (including dry eye syndrome), active or inactive keratitis with compromise of PMA P930014/S126: FDA Summary of Safety and Effectiveness Data Page 12 {12} the refractive capability of the cornea, keratoconjunctivitis sicca with compromise of visual function, active keratouveitis, endothelial dystrophy (Fuch's and non-guttate), keratoconus, etc. 4. Clinically significant ocular surface disease that would affect study measurements based on Investigator expert medical opinion 5. History of previous intraocular or corneal surgery 6. Pregnant/lactating or has another condition with associated fluctuation of hormones that could lead to refractive changes 7. History of amblyopia or monofixation syndrome with poor stereoscopic vision 8. Current or recent use of an alpha-1-selective adrenoceptor blocking agent or an antagonist of alpha1A adrenoceptor (e.g. Flomax (tamsulosin HCL), Hytrin, or Cardura) that in the opinion of the investigator would potentially require mechanical or surgical manipulation to enlarge the pupil 9. Concurrent participation in another clinical trial that, in the Investigator's opinion, may confound the results of the current study 10. Any other ocular condition or systemic co-morbidity that, in the opinion of the Investigator, may confound the results of this study or prohibit the completion of the study assessments or increase the risk for the subject 11. Subjects with conditions that, in the Investigator's opinion, increase the risk of zonular rupture during cataract extraction procedure (e.g., pseudoexfoliation syndrome, Marfan syndrome) that may affect the postoperative centration or tilt of the lens 12. Any other planned ocular surgical procedures including but not limited to limbal relaxing incision (LRI), astigmatic keratotomy, laser-assisted in situ keratomileusis (LASIK), and retinal laser treatment within the study time frame 13. Subjects who desire monovision correction The following were intraoperative criteria for not implanting the device: 1. Surgical complications including but not limited to loss of zonular integrity/zonular weakness, zonular rupture, anterior capsular rupture interfering with the stability of the IOL, posterior capsule rupture, any evidence of fluid misdirection during the cataract procedure with progressive shallowing of the anterior chamber, uncontrollable intraocular pressure (IOP) 2. Mechanical or surgical manipulation of the pupil 3. Excessive iris mobility 4. Inability to place the IOL in the capsular bag due to surgical complications PMA P930014/S126: FDA Summary of Safety and Effectiveness Data Page 13 {13} ## 2. Follow-up Schedule All subjects were scheduled to return for follow-up examinations postoperatively at the time points described in Table 5. Preoperatively and postoperatively, several clinical evaluations were performed, as listed in Table 6. Adverse events and complications were recorded at all visits. The key timepoints are shown below in the tables summarizing safety and effectiveness. Table 5: Pivotal Study Design | Time from Implantation | First Eye | Second Eye | | --- | --- | --- | | -28 to 0 days pre-operatively | Visit 0 (Screening [First and Second eye]) | | | Within 2 business days of first eye operative visit (Visit 00) | Randomization | | | Operative (IOL implantation) | Visit 00 | Visit 00A* | | 1 - 2 days post-operatively | Visit 1 (monocular) | Visit 1A (monocular) | | 7 - 14 days post operatively | Visit 2 (monocular) | Visit 2A (monocular) | | 30 - 60 days post-operatively (after Second eye implantation) | Visit 3A (monocular [First and Second eye] and binocular) | | | 120 - 180 days post-operatively (after Second eye implantation) | Visit 4A (monocular [First and Second eye] and binocular) | | *NOTE: IOL implantation in the second eye was intended to occur between 7 and 14 days after IOL implantation in the first eye. PMA P930014/S126: FDA Summary of Safety and Effectiveness Data Page 14 {14} **Table 6: Schedule of Visits** | Visit | Both Eyes | 1^{st} Operative Eye | 2^{nd} Operative Eye | Both Eyes | Early Exit | | --- | --- | --- | --- | --- | --- | | Visit 0 Day -28-0 Preoperative | Visit 00^{1} Day 0 Operative | Visit 1 Day 1-2 Post Visit 00 | Visit 2 Day 7-14 Post Visit 00 | Visit 00A^{2} 7-14 Days Post Visit 00 | Visit 1A Day 1-2 Post Visit 00A | Visit 2A 7-14 Days Post Visit 00A | Visit 3A 30-60 Days Post Visit 00A | Visit 4A^{3} 120-180 Days Post Visit 00A | | **General Assessments and Procedures** | | Informed Consent | X | | | | | | | | | | | Demographics | X | | | | | | | | | | | Medical History | X | | | | | | | | | | | Concomitant Medications | X | X | X | X | X | X | X | X | X | X | | Urine Pregnancy Test^{4} | X | | | | | | | | | | | Inclusion/Exclusion | X | X | | | X | | | | | | | **Ophthalmic Assessments** | | QUVID questionnaire (for visual disturbance) | X | | | | | | | X | X | X | | IOLSAT questionnaire (for spectacle need) | X | | | | | | | X | X | X | | Anterior Chamber Depth | X | | | | | | | | | | | Axial Length | X | | | | | | | | | | | Keratometry | X | | | | | | | | | | | Predicted Target Residual Refractive Error^{5} | X | | | | | | | | | | | Manifest Refraction (4 m) | X | | | X | | | X | X | X | X | | Distance VA at 4 m | | • Photopic Uncorrected | X | | X | X | | X | X | X | X^{6} | X | | • Photopic Corrected | X | | | X | | | X | X | X^{6} | X | | • Low Contrast (10%) Photopic Best Corrected | | | | | | | | | X | | | • Low Contrast (25%) Photopic Best Corrected | | | | | | | | | X | | | Defocus Curve (4 m) | | | | | | | | | X^{6} | | | Photopic Pupil Size (VA Chart) | X | | | | | | | | X | | | Intermediate VA at 66 cm | | • Photopic Uncorrected | | | | | | | | X | X^{6} | | | • Photopic Distance Corrected | | | | | | | | X | X^{6} | | PMA P930014/S126: FDA Summary of Safety and Effectiveness Data Page 15 {15} | Visit | Both Eyes | 1^{st} Operative Eye | | | 2^{nd} Operative Eye | | | Both Eyes | | Early Exit | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | Visit 0 Day -28-0 Preoperative | Visit 00^{1} Day 0 Operative | Visit 1 Day 1-2 Post Visit 00 | Visit 2 Day 7-14 Post Visit 00 | Visit 00A^{2} 7-14 Days Post Visit 00 | Visit 1A Day 1-2 Post Visit 00A | Visit 2A 7-14 Days Post Visit 00A | Visit 3A 30-60 Days Post Visit 00A | Visit 4A^{3} 120-180 Days Post Visit 00A | | | • Low Contrast (10%) Photopic Distance Corrected | | | | | | | | | X | | | • Low Contrast (25%) Photopic Distance Corrected | | | | | | | | | X | | | Near VA at 40 cm | | | | | | | | | | | | • Photopic Uncorrected | | | | | | | | X | X^{6} | | | • Photopic Distance Corrected | | | | | | | | X | X^{6} | | | • Low Contrast (10%) Photopic Distance Corrected | | | | | | | | | X | | | • Low Contrast (25%) Photopic Distance Corrected | | | | | | | | | X | | | Mesopic Pupil Size (Contrast Chart) | | | | | | | | | X | | | Contrast Sensitivity | | | | | | | | | | | | • Mesopic without Glare | | | | | | | | | X | | | • Mesopic with Glare | | | | | | | | | X | | | Slit Lamp Examination | X | | X | X | | X | X | X | X | X | | Aqueous Signs | | | X | X | | X | X | X | X | X | | IOL Observations | | | X | X | | X | X | X | X | X | | IOL Position Change | | | X | X | | X | X | X | X | X | | Subjective PCO | | | X | X | | X | X | X | X | X | | Posterior Capsulotomy | | | X | X | | X | X | X | X | X | | Intraocular Pressure | X | | X | X | | X | X | X | X | X | | Dilated Fundus Exam | X | | | | | | | X | X | X | | Fundus Visualization | | | | | | | | X | X | X | | **Surgical Procedure & Assessments** | | | | | | | | | | | | Cataract Surgery | | X | | | X | | | | | | | Lens Information | | X | | | X | | | | | | | Incision Location^{7} | | X | | | X | | | | | | PMA P930014/S126: FDA Summary of Safety and Effectiveness Data Page 16 {16} | Visit | Both Eyes | 1^{st} Operative Eye | | | 2^{nd} Operative Eye | | | Both Eyes | | | Early Exit | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | Visit 0 Day -28-0 Preoperative | Visit 00^{1} Day 0 Operative | Visit 1 Day 1-2 Post Visit 00 | Visit 2 Day 7-14 Post Visit 00 | Visit 00A^{2} 7-14 Days Post Visit 00 | Visit 1A Day 1-2 Post Visit 00A | Visit 2A 7-14 Days Post Visit 00A | Visit 3A 30-60 Days Post Visit 00A | Visit 4A^{3} 120-180 Days Post Visit 00A | | | Final Incision Size^{7,8} | | X | | | X | | | | | | | | Problems during Surgery | | X | | | X | | | | | | | | Other Surgical Procedures | | X | | | X | | | | | | | | **Adverse Events & Device Deficiencies** | | | | | | | | | | | | | Adverse Events^{9} | X | X | X | X | X | X | X | X | X | X | X | | Secondary Surgical Interventions | | X | X | X | X | X | X | X | X | X | X | | Device Deficiencies | | X | X | X | X | X | X | X | X | X | X | 1. Visit 00 (1st eye surgery) must occur within 28 calendar days from Pre-Operative Visit (Visit 0). 2. Visit 00A (2nd eye surgery) must occur between 7 and 14 calendar days after Visit 00. 3. If necessary, Visit 4A may be completed over 2 days within a two-week period. Both days must fall within the specified visit window. 4. In women of child bearing potential only. 5. Data is reported in EDC at the surgical visit but may be collected at a previous visit. 6. Testing is conducted monocular (bilaterally) and binocular. 7. Capture in source (not captured in EDC). 8. Only measure in cases with surgical complications. 9. Collected from time of consent onward. ### 3. Clinical Endpoints - With regard to effectiveness, the co-primary effectiveness endpoints were: - AcrySof™ IQ Vivity™ IOL is superior to the control in mean monocular photopic distance-corrected intermediate visual acuity (DCIVA). - Monocular photopic BCDVA (logMAR). To demonstrate that the AcrySof™ IQ Vivity™ IOL is non-inferior to the control in mean monocular photopic BCDVA. - Monocular depth of focus (measured in the negative direction from 0) at 0.20 logMAR. To demonstrate that the monocular mean defocus curve for the AcrySof™ IQ Vivity™ IOL has a range of defocus at least 0.5 D greater negative range than the control at 0.20 logMAR. - Percentage of eyes achieving monocular photopic DCIVA of 0.20 logMAR or better. To demonstrate that the AcrySof™ IQ PMA P930014/S126: FDA Summary of Safety and Effectiveness Data Page 17 {17} Vivity™ IOL has at least 50% of eyes achieving DCIVA of 0.20 logMAR or better. - • With regard to effectiveness, the secondary effectiveness endpoints were: - ○ To demonstrate that AcrySof™ IQ Vivity™ IOL is superior to the control in mean monocular photopic distance-corrected near visual acuity (DCNVA). In addition, the following performance targets will also be assessed to demonstrate clinical significance: - ▪ Demonstrate at least 50% of eyes with the AcrySof™ IQ Vivity™ IOL achieve a monocular DCNVA of 0.30 logMAR or better - ▪ Percentage of eyes achieving monocular DCNVA of 0.30 logMAR or better in the AcrySof™ Vivity™ IOL group is at least 25 percentage points higher than the control group - ○ To demonstrate that the AcrySof™ IQ Vivity™ IOL is superior to the control with respect to proportion of subjects who respond “Never” to Q1 of the IOLSAT questionnaire (Overall, in the past 7 days, how often did you need to wear eyeglasses to see?) - ○ To describe mean monocular photopic uncorrected intermediate visual acuity (UCIVA) outcomes - ○ To describe mean monocular photopic uncorrected distance visual acuity (UCDVA) outcomes - • With regard to safety, the co-primary safety objectives were: - ○ To demonstrate that the AcrySof™ IQ Vivity™ IOL adverse event rates are not worse than the historical control SPE rates, as defined in IS EN ISO 11979-7:2014 - ○ To describe monocular mesopic contrast sensitivity test (with and without glare) outcomes The Secondary Safety Objective was to estimate rates of severe and most bothersome (separately) visual disturbances as reported by subjects using a questionnaire at Visit 4A (120-180d postoperative). All of these clinical endpoints were evaluated at 6 months postoperatively (Visit 4A). Because AcrySof™ IQ Vivity™ IOLs are modifications to other existing IOLs, conclusions regarding device safety and effectiveness are also substantiated by the results of the studies of the parent IOLs. ### **B. Accountability of PMA Cohort** At the time of database lock, of 242 subjects enrolled in the PMA study, 220 subjects were implanted with a study lens in at least one eye and attended at least one follow-up visit. The remaining subjects either failed screening (n=21) or were discontinued prior to implantation (n=1 due to a worsening of PMA P930014/S126: FDA Summary of Safety and Effectiveness Data Page 18 {18} a pre-existing condition). Of the 220 subjects, 107 subjects received the AcrySof™ IQ Vivity™ IOL and 113 received the aspheric Monofocal Control IOL. One of the subjects in the AcrySof™ IQ Vivity™ IOL group was not bilaterally implanted and did not contribute to binocular assessments. Two subjects in the monofocal control group discontinued the study prior to 6 months. Subject accountability information is presented in Table 7 for the AcrySof™ IQ Vivity™ IOL first eyes and Table 8 for the Monofocal Control IOL first eyes. Subject compliance with the follow-up schedule was excellent at 6 months for an overall percent accountability of first implanted eyes of 100% (n= 107) and 99.1% (n=106) for the AcrySof™ IQ Vivity™ IOL and Monofocal Control IOL eyes respectively. Table 7: AcrySof™ IQ Vivity First Eyes Accountability | Subject Status | N | 1 Day n (%) | 1 Week n (%) | 1 Month n (%) | 6 Months n (%) | | --- | --- | --- | --- | --- | --- | | | 107 | | | | | | Available for Analysis | | 107 (100.0) | 107 (100.0) | 107 (100.0) | 107 (100.0) | | Missing Subjects | | | | | | | Discontinued | | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | | Missed Visit | | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | | Lost to follow-up | | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | | Active | | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | | Percent Accountability | | (100.0) | (100.0) | (100.0) | (100.0) | Table 8: Monofocal Control IOL First Eyes Accountability | Subject Status | N | 1 Day n (%) | 1 Week n (%) | 1 Month n (%) | 6 Months n (%) | | --- | --- | --- | --- | --- | --- | | | 113 | | | | | | Available for Analysis | | 113 (100.0) | 113 (100.0) | 113 (100.0) | 111 (98.2) | | Missing Subjects | | | | | | | Discontinued | | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (0.9) | | Missed Visit | | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | | Lost to follow-up | | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (0.9) | | Active | | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | | Percent Accountability | | (100.0) | (100.0) | (100.0) | (99.1) | ### C. Study Population Demographics and Baseline Parameters The demographics of the study population are typical for a randomized, prospective, multicenter clinical study of intraocular lenses performed in the US. The subject demographics and first eye baseline characteristics were similar between the AcrySof™ IQ Vivity™ and Monofocal IOL groups. PMA P930014/S126: FDA Summary of Safety and Effectiveness Data Page 19 {19} Approximately two-thirds of the subjects in each group were $\geq 65$ years of age, and a higher rate of female participation was observed in both groups. Tables 9 and 10 present the study population demographics and baseline parameters. **Table 9: Demographic Statistics (All-Implanted Set)** | Parameter | AcrySof^{TM} IQ Vivity IOL (N = 107) | Monofocal Control IOL (N = 113) | Overall (N = 220) | | --- | --- | --- | --- | | **Age (Years), n (%)** | | | | | <65 | 25 (23.4) | 30 (26.5) | 55 (25.0) | | ≥65 | 82 (76.6) | 83 (73.5) | 165 (75.0) | | Mean (SD) | 68.8 (7.82) | 68.8 (6.63) | 68.8 (7.22) | | Median | 69.0 | 69.0 | 69.0 | | (Min, Max) | (29, 83) | (50, 82) | (29, 83) | | **Sex, n (%)** | | | | | Female | 59 (55.1) | 64 (56.6) | 123 (55.9) | | Male | 48 (44.9) | 49 (43.4) | 97 (44.1) | | Unknown | 0 (0.0) | 0 (0.0) | 0 (0.0) | | Undifferentiated | 0 (0.0) | 0 (0.0) | 0 (0.0) | | **Race, n (%)** | | | | | White | 105 (98.1) | 110 (97.3) | 215 (97.7) | | Black or African American | 1 (0.9) | 1 (0.9) | 2 (0.9) | | American Indian or Alaska Native | 0 (0.0) | 1 (0.9) | 1 (0.5) | | Asian | 0 (0.0) | 0 (0.0) | 0 (0.0) | | Native Hawaiian or Other Pacific Islander | 0 (0.0) | 0 (0.0) | 0 (0.0) | | Multi-Racial | 0 (0.0) | 0 (0.0) | 0 (0.0) | | Other | 1 (0.9) | 1 (0.9) | 2 (0.9) | | **Ethnicity, n (%)** | | | | | Hispanic or Latino | 2 (1.9) | 2 (1.8) | 4 (1.8) | | Not Hispanic or Latino | 104 (97.2) | 111 (98.2) | 215 (97.7) | | Not Reported | 0 (0.0) | 0 (0.0) | 0 (0.0) | | Unknown | 1 (0.9) | 0 (0.0) | 1 (0.5) | PMA P930014/S126: FDA Summary of Safety and Effectiveness Data Page 20 {20} **Table 10: Baseline Characteristics, First Eye (All-Implanted Analysis Set)** | | AcrySof^{TM} IQ Vivity IOL (N = 107) | Monofocal Control IOL (N = 113) | Overall (N = 220) | | --- | --- | --- | --- | | **Best Corrected Distance VA (logMAR)** | | | | | n | 107 | 113 | 220 | | Mean (SD) | 0.230 (0.1877) | 0.243 (0.2216) | 0.237 (0.2054) | | Median | 0.20 | 0.20 | 0.20 | | (Min, Max) | (-0.08, 1.10) | (-0.18, 1.10) | (-0.18, 1.10) | | **Axial Length (mm)** | | | | | n | 107 | 113 | 220 | | Mean (SD) | 23.643 (0.7663) | 23.733 (0.7242) | 23.689 (0.7446) | | Median | 23.58 | 23.72 | 23.69 | | (Min, Max) | (21.86, 25.67) | (21.89, 25.78) | (21.86, 25.78) | | **Axial Length Category, n (%)** | | | | | Total | 107 | 113 | 220 | | Short (<21 mm) | 0 (0.0) | 0 (0.0) | 0 (0.0) | | Medium (21-26 mm) | 107 (100.0) | 113 (100.0) | 220 (100.0) | | Long (>26 mm) | 0 (0.0) | 0 (0.0) | 0 (0.0) | | **Anterior Chamber Depth (mm)** | | | | | n | 107 | 113 | 220 | | Mean (SD) | 3.246 (0.3174) | 3.205 (0.3117) | 3.225 (0.3144) | | Median | 3.22 | 3.17 | 3.21 | | (Min, Max) | (2.58, 4.21) | (2.54, 3.97) | (2.54, 4.21) | | **Corneal Astigmatism = abs (K1-K2)** | | | | | n | 107 | 113 | 220 | | Mean (SD) | 0.516 (0.2450) | 0.507 (0.2690) | 0.511 (0.2571) | | Median | 0.50 | 0.47 | 0.50 | | (Min, Max) | (0.00, 0.98) | (0.00, 1.26) | (0.00, 1.26) | A summary of photopic pupil size for Vivity and Monofocal Control first implanted eyes at baseline is presented in Table 11. **Table 11: Baseline Photopic Pupil Size of Vivity and Monofocal Control IOL First Eyes** | | Vivity^{TM} IOL First Eyes N = 107 | Monofocal Control IOL First Eyes N = 113 | | --- | --- | --- | | n | 107 | 113 | | Mean (SD) | 4.03 (0.859) | 4.08 (0.981) | | Median | 4.0 | 4.0 | | (Min, Max) | (2.4, 6.5) | (2.0, 7.8) | #### **D. Safety and Effectiveness Results** PMA P930014/S126: FDA Summary of Safety and Effectiveness Data Page 21 {21} ## 1. Safety Results The analysis of safety was based on the safety cohort of 220 implanted subjects (219 bilaterally implanted): 107 AcrySof™ IQ Vivity™ subjects (106 bilaterally implanted) and 113 control subjects (113 bilaterally implanted). The key safety outcomes for this study are presented below in Tables 12 to 20. Adverse effects are reported in Tables 12 to 18. The first co-primary safety objective was to demonstrate that the AcrySof™ IQ Vivity™ IOL adverse event rates are not worse than the historical control SPE rates, as defined in ISO 11979-7:2014. ### **Adverse effects that occurred in the PMA clinical study:** The incidences of cumulative and persistent adverse events (AEs) including 1-sided 95% lower confidence limits (CL) for the AcrySof™ IQ Vivity™ IOL and the Monofocal Control IOL as compared to the ISO 11979-7:2014 historical grid rates are provided in Table 12 (first implanted eyes in each IOL group), Table 13 (second implanted eyes in each IOL group), and Table 14 (all implanted eyes in each IOL group). If the same event occurred multiple times in an eye, only the first occurrence is counted in the tables below. The safety and performance endpoint (SPE) rate is considered not exceeded if the 1-sided 95% lower CL for an AE is less than the SPE%. No cumulative adverse events exceeded the established rates according to ISO 11979-7:2014. No persistent adverse events (adverse events in the ISO grid that are observed at the 6-month postoperative visit) were observed for 107 subjects implanted with AcrySof™ IQ Vivity™ IOL. Secondary Surgical Interventions (SSIs) occurred in 2 second eyes implanted with the AcrySof™ IQ Vivity™ IOL that each had 1 SSI; both cases were assessed as not related to the IOL (n = 1 cortical remnant removal and n = 1 surgical removal of retained nuclear fragment). No AEs specifically related to AcrySof™ IQ Vivity™ IOL design features were observed. In first and second eyes with the AcrySof™ IQ Vivity™ IOL, ocular AEs occurring at a rate of ≥ 2% were posterior capsule opacification (PCO) (4.7% (n=5) and 5.7% (n=6), respectively), punctate keratitis (3.7% (n=4) and 2.8% (n=3), respectively), vitreous detachment (3.7% (n=4) and 3.8% (n=4), respectively), blepharitis (2.8% (n=3), second eye only), and eye pain (2.8% (n=3), second eye only) (Tables 15 and 16). For comparison, in first and second eyes with the Monofocal Control IOL, ocular AEs occurring at a rate of ≥ 2% were PCO (8.0% (n=9) and 7.1% (n=8), respectively), punctate keratitis (2.7% (n=3) and 3.5% (n=4), PMA P930014/S126: FDA Summary of Safety and Effectiveness Data Page 22 {22} respectively), vitreous detachment (2.7% (n=3) and 2.7% (n=3), respectively), and IOP increased (3.5% (n=4), first eye only). **Table 12: Cumulative and Persistent Serious Adverse Events in First Eyes and SPE Rates for AcrySof™ IQ Vivity™ and Monofocal IOL Group (Safety Analysis Set)** | Cumulative Serious Adverse Events | AcrySof™ IQ Vivity™ IOL First Implanted Eyes N = 107 | | Monofocal Control IOL First Implanted Eyes N = 113 | | SPE % | | --- | --- | --- | --- | --- | --- | | | n (%) | 1-sided 95% Lower CL | n (%) | 1-sided 95% Lower CL | | | Cystoid macular oedema | 1 (0.9) | 0.05 | 1 (0.9) | 0.05 | 3.0 | | Hypopyon | 0 (0.0) | 0.00 | 0 (0.0) | 0.00 | 0.3 | | Endophthalmitis | 0 (0.0) | 0.00 | 0 (0.0) | 0.00 | 0.1 | | Lens dislocated from posterior chamber | 0 (0.0) | 0.00 | 0 (0.0) | 0.00 | 0.1 | | Pupillary block | 0 (0.0) | 0.00 | 0 (0.0) | 0.00 | 0.1 | | Retinal detachment | 0 (0.0) | 0.00 | 1 (0.9) | 0.05 | 0.3 | | Secondary surgical intervention | 0 (0.0) | 0.00 | 2 (1.8)* | 0.32 | 0.8 | | Other | | | | | | | Hyphaema | 1 (0.9) | 0.05 | 0 (0.0) | 0.00 | N/A | | Transient ischaemic attack | 1 (0.9) | 0.05 | 0 (0.0) | 0.00 | N/A | | Photopsia | 0 (0.0) | 0.00 | 1 (0.9) | 0.05 | N/A | | **Persistent Serious Adverse Events** | | | | | | | Corneal stroma oedema | 0 (0.0) | 0.00 | 0 (0.0) | 0.00 | 0.3 | | Cystoid macular oedema | 0 (0.0) | 0.00 | 0 (0.0) | 0.00 | 0.5 | | Iritis | 0 (0.0) | 0.00 | 0 (0.0) | 0.00 | 0.3 | | Raised IOP requiring treatment | 0 (0.0) | 0.00 | 0 (0.0) | 0.00 | 0.4 | Percentages are calculated as (n/N)(100) *One SSI was a pars plana vitrectomy and one SSI was an IOL explant PMA P930014/S126: FDA Summary of Safety and Effectiveness Data Page 23 {23} Table 13: Cumulative and Persistent Serious Adverse Events in Second Eyes and SPE Rates for AcrySof™ IQ Vivity™ and Monofocal IOL Group (Safety Analysis Set) | | AcrySof™ IQ Vivity™ IOL Second Implanted Eyes N = 106 | | Monofocal Control IOL Second Implanted Eyes N = 113 | | SPE % | | --- | --- | --- | --- | --- | --- | | | n (%) | 1-sided 95% Lower CL | n (%) | 1-sided 95% Lower CL | | | Cumulative Serious Adverse Events | | | | | | | Cystoid macular oedema | 0 (0.0) | 0.00 | 1 (0.9) | 0.05 | 3.0 | | Hypopyon | 0 (0.0) | 0.00 | 0 (0.0) | 0.00 | 0.3 | | Endophthalmitis | 0 (0.0) | 0.00 | 0 (0.0) | 0.00 | 0.1 | | Lens dislocated from posterior chamber | 0 (0.0) | 0.00 | 0 (0.0) | 0.00 | 0.1 | | Pupillary block | 0 (0.0) | 0.00 | 0 (0.0) | 0.00 | 0.1 | | Retinal detachment | 0 (0.0) | 0.00 | 0 (0.0) | 0.00 | 0.3 | | Secondary surgical intervention | 2 (1.9)* | 0.34 | 0 (0.0) | 0.00 | 0.8 | | Other | | | | | | | Cataract operation complication** | 2 (1.9) | 0.34 | 0 (0.0) | 0.00 | N/A | | Persistent Serious Adverse Events | | | | | | | Corneal stroma oedema | 0 (0.0) | 0.00 | 0 (0.0) | 0.00 | 0.3 | | Cystoid macular oedema | 0 (0.0) | 0.00 | 0 (0.0) | 0.00 | 0.5 | | Iritis | 0 (0.0) | 0.00 | 0 (0.0) | 0.00 | 0.3 | | Raised IOP requiring treatment | 0 (0.0) | 0.00 | 0 (0.0) | 0.00 | 0.4 | Percentages are calculated as (n/N)(100) *Both SSIs were unrelated to the IOL and were performed to remove retained cataract material from the eye. **Both events were due to retained cataract material in the eye PMA P930014/S126: FDA Summary of Safety and Effectiveness Data Page 24 {24} Table 14: Cumulative and Persistent Serious Adverse Events in All Eyes and SPE Rates for AcrySof™ IQ Vivity™ and Monofocal IOL Group (Safety Analysis Set) | | AcrySof™ IQ Vivity™ IOL All Implanted Eyes N = 213 | | Monofocal Control IOL All Implanted Eyes N = 226 | | | | --- | --- | --- | --- | --- | --- | | Cumulative Serious Adverse Events | n (%) | 1-sided 95% Lower CL | n (%) | 1-sided 95% Lower CL | SPE % | | Cystoid macular oedema | 1 (0.5) | 0.02 | 2 (0.9) | 0.16 | 3.0 | | Hypopyon | 0 (0.0) | 0.00 | 0 (0.0) | 0.00 | 0.3 | | Endophthalmitis | 0 (0.0) | 0.00 | 0 (0.0) | 0.00 | 0.1 | | Lens dislocated from posterior chamber | 0 (0.0) | 0.00 | 0 (0.0) | 0.00 | 0.1 | | Pupillary block | 0 (0.0) | 0.00 | 0 (0.0) | 0.00 | 0.1 | | Retinal detachment | 0 (0.0) | 0.00 | 1 (0.4) | 0.02 | 0.3 | | Secondary surgical intervention | 2 (0.9)* | 0.17 | 2 (0.9)*** | 0.16 | 0.8 | | Other | | | | | | | Cataract operation complication** | 2 (0.9) | 0.17 | 0 (0.0) | 0.00 | N/A | | Hyphaema | 1 (0.5) | 0.02 | 0 (0.0) | 0.00 | N/A | | Transient ischaemic attack | 1 (0.5) | 0.02 | 0 (0.0) | 0.00 | N/A | | Photopsia | 0 (0.0) | 0.00 | 1 (0.4) | 0.02 | N/A | | Persistent Serious Adverse Events | | | | | | | Corneal stroma oedema | 0 (0.0) | 0.00 | 0 (0.0) | 0.00 | 0.3 | | Cystoid macular oedema | 0 (0.0) | 0.00 | 0 (0.0) | 0.00 | 0.5 | | Iritis | 0 (0.0) | 0.00 | 0 (0.0) | 0.00 | 0.3 | | Raised IOP requiring treatment | 0 (0.0) | 0.00 | 0 (0.0) | 0.00 | 0.4 | Percentages are calculated as (n/N)(100) *Both SSIs in the Vivity IOL group were unrelated to the IOL and were performed to remove retained cataract material from the eye **Both events were due to retained cataract material in the eye ***One SSI with the Monofocal Control IOL was a pars plana vitrectomy and the other was an IOL explant PMA P930014/S126: FDA Summary of Safety and Effectiveness Data Page 25 {25} **Table 15: Ocular Adverse Events (Serious and Non-Serious Combined), First Eye (Safety Analysis Set)** | Preferred Term | AcrySof™ IQ Vivity™ IOL N = 107 | | | Monofocal Control IOL N = 113 | | | | --- | --- | --- | --- | --- | --- | --- | | | n (%) | 2-sided 95% CI | E | n (%) | 2-sided 95% CI | E | | Posterior capsule opacification | 5 (4.7) | (1.53, 10.57) | 5 | 9 (8.0) | (3.71, 14.58) | 9 | | Punctate keratitis | 4 (3.7) | (1.03, 9.30) | 4 | 3 (2.7) | (0.55, 7.56) | 3 | | Vitreous detachment | 4 (3.7) | (1.03, 9.30) | 4 | 3 (2.7) | (0.55, 7.56) | 3 | | Intraocular pressure increased | 2 (1.9) | (0.23, 6.59) | 2 | 4 (3.5) | (0.97, 8.82) | 4 | | Blepharitis | 2 (1.9) | (0.23, 6.59) | 2 | 2 (1.8) | (0.22, 6.25) | 2 | | Iritis | 1 (0.9) | (0.02, 5.10) | 1 | 2 (1.8) | (0.22, 6.25) | 2 | | Cystoid macular oedema | 1 (0.9) | (0.02, 5.10) | 1 | 1 (0.9) | (0.02, 4.83) | 1 | | Dry eye | 1 (0.9) | (0.02, 5.10) | 1 | 1 (0.9) | (0.02, 4.83) | 1 | | Macular fibrosis | 2 (1.9) | (0.23, 6.59) | 2 | 0 (0.0) | (0.00, 3.21) | 0 | | Photopsia | 0 (0.0) | (0.00, 3.39) | 0 | 2 (1.8) | (0.22, 6.25) | 2 | | Cataract operation complication | 0 (0.0) | (0.00, 3.39) | 0 | 1 (0.9) | (0.02, 4.83) | 1 | | Chalazion | 1 (0.9) | (0.02, 5.10) | 1 | 0 (0.0) | (0.00, 3.21) | 0 | | Corneal erosion | 0 (0.0) | (0.00, 3.39) | 0 | 1 (0.9) | (0.02, 4.83) | 1 | | Eye pain | 0 (0.0) | (0.00, 3.39) | 0 | 1 (0.9) | (0.02, 4.83) | 1 | | Eyelid pain | 0 (0.0) | (0.00, 3.39) | 0 | 1 (0.9) | (0.02, 4.83) | 1 | | Hyphaema | 1 (0.9) | (0.02, 5.10) | 1 | 0 (0.0) | (0.00, 3.21) | 0 | | Lacrimation increased | 0 (0.0) | (0.00, 3.39) | 0 | 1 (0.9) | (0.02, 4.83) | 1 | | Lens disorder | 0 (0.0) | (0.00, 3.39) | 0 | 1 (0.9) | (0.02, 4.83) | 1 | | Lens extraction | 0 (0.0) | (0.00, 3.39) | 0 | 1 (0.9) | (0.02, 4.83) | 1 | | Migraine with aura | 0 (0.0) | (0.00, 3.39) | 0 | 1 (0.9) | (0.02, 4.83) | 1 | | Photophobia | 1 (0.9) | (0.02, 5.10) | 1 | 0 (0.0) | (0.00, 3.21) | 0 | | Retinal detachment | 0 (0.0) | (0.00, 3.39) | 0 | 1 (0.9) | (0.02, 4.83) | 1 | | Retinal exudates | 0 (0.0) | (0.00, 3.39) | 0 | 1 (0.9) | (0.02, 4.83) | 1 | | Retinal haemorrhage | 0 (0.0) | (0.00, 3.39) | 0 | 1 (0.9) | (0.02, 4.83) | 1 | | Retinal telangiectasia | 0 (0.0) | (0.00, 3.39) | 0 | 1 (0.9) | (0.02, 4.83) | 1 | | Retinopathy | 0 (0.0) | (0.00, 3.39) | 0 | 1 (0.9) | (0.02, 4.83) | 1 | PMA P930014/S126: FDA Summary of Safety and Effectiveness Data Page 26 {26} | Preferred Term | AcrySof™ IQ Vivity™ IOL N = 107 | | | Monofocal Control IOL N = 113 | | | | --- | --- | --- | --- | --- | --- | --- | | | n (%) | 2-sided 95% CI | E | n (%) | 2-sided 95% CI | E | | Sweat gland tumour | 1 (0.9) | (0.02, 5.10) | 1 | 0 (0.0) | (0.00, 3.21) | 0 | | Transient ischaemic attack | 1 (0.9) | (0.02, 5.10) | 1 | 0 (0.0) | (0.00, 3.21) | 0 | | Vision blurred | 0 (0.0) | (0.00, 3.39) | 0 | 1 (0.9) | (0.02, 4.83) | 1 | | Vitrectomy | 0 (0.0) | (0.00, 3.39) | 0 | 1 (0.9) | (0.02, 4.83) | 1 | | Vitreous degeneration | 0 (0.0) | (0.00, 3.39) | 0 | 1 (0.9) | (0.02, 4.83) | 1 | If an eye has multiple occurrences of an AE, the eye is presented only once in the respective eye count column (n) for the corresponding AE. Events are counted each time in the event (E) column. N= Number of eyes in each treatment group; n= Number of eyes with event; E= Number of events; CI= Confidence Interval Percentages are calculated as (n/N)(100). Table 16: Ocular Adverse Events (Serious and Non-Serious Combined), Second Eye (Safety Analysis Set) | Preferred Term | AcrySof™ IQ Vivity™ IOL (N = 106) | | | Monofocal Control IOL (N = 113) | | | | --- | --- | --- | --- | --- | --- | --- | | | n (%) | 2-sided 95% CI | E | n (%) | 2-sided 95% CI | E | | Posterior capsule opacification | 6 (5.7) | (2.11, 11.91) | 6 | 8 (7.1) | (3.11, 13.47) | 8 | | Punctate keratitis | 3 (2.8) | (0.59, 8.05) | 3 | 4 (3.5) | (0.97, 8.82) | 4 | | Vitreous detachment | 4 (3.8) | (1.04, 9.38) | 4 | 3 (2.7) | (0.55, 7.56) | 3 | | Blepharitis | 3 (2.8) | (0.59, 8.05) | 3 | 2 (1.8) | (0.22, 6.25) | 2 | | Intraocular pressure increased | 2 (1.9) | (0.23, 6.65) | 2 | 2 (1.8) | (0.22, 6.25) | 2 | | Iritis | 2 (1.9) | (0.23, 6.65) | 3 | 2 (1.8) | (0.22, 6.25) | 2 | | Eye pain | 3 (2.8) | (0.59, 8.05) | 3 | 0 (0.0) | (0.00, 3.21) | 0 | | Macular fibrosis | 2 (1.9) | (0.23, 6.65) | 2 | 2 (1.8) | (0.22, 6.25) | 2 | | Cataract operation complication | 2 (1.9) | (0.23, 6.65) | 2 | 0 (0.0) | (0.00, 3.21) | 0 | | Dry eye | 1 (0.9) | (0.02, 5.14) | 1 | 1 (0.9) | (0.02, 4.83) | 1 | | Photophobia | 1 (0.9) | (0.02, 5.14) | 1 | 1 (0.9) | (0.02, 4.83) | 1 | | Retinal haemorrhage | 1 (0.9) | (0.02, 5.14) | 1 | 1 (0.9) | (0.02, 4.83) | 1 | | Surgical procedure repeated | 2 (1.9) | (0.23, 6.65) | 2 | 0 (0.0) | (0.00, 3.21) | 0 | | Chemical burn | 0 (0.0) | (0.00, 3.42) | 0 | 1 (0.9) | (0.02, 4.83) | 1 | PMA P930014/S126: FDA Summary of Safety and Effectiveness Data Page 27 {27} | Preferred Term | AcrySof^{TM} IQ Vivity^{TM} IOL (N = 106) | | | Monofocal Control IOL (N = 113) | | | | --- | --- | --- | --- | --- | --- | --- | | | n (%) | 2-sided 95% CI | E | n (%) | 2-sided 95% CI | E | | Conjunctival deposit | 0 (0.0) | (0.00, 3.42) | 0 | 1 (0.9) | (0.02, 4.83) | 1 | | Conjunctival laceration | 0 (0.0) | (0.00, 3.42) | 0 | 1 (0.9) | (0.02, 4.83) | 1 | | Corneal dystrophy | 1 (0.9) | (0.02, 5.14) | 1 | 0 (0.0) | (0.00, 3.21) | 0 | | Cystoid macular oedema | 0 (0.0) | (0.00, 3.42) | 0 | 1 (0.9) | (0.02, 4.83) | 1 | | Eye inflammation | 0 (0.0) | (0.00, 3.42) | 0 | 1 (0.9) | (0.02, 4.83) | 1 | | Lens disorder | 0 (0.0) | (0.00, 3.42) | 0 | 1 (0.9) | (0.02, 4.83) | 1 | | Meibomian gland dysfunction | 0 (0.0) | (0.00, 3.42) | 0 | 1 (0.9) | (0.02, 4.83) | 1 | | Migraine with aura | 0 (0.0) | (0.00, 3.42) | 0 | 1 (0.9) | (0.02, 4.83) | 1 | | Ophthalmic herpes simplex | 0 (0.0) | (0.00, 3.42) | 0 | 1 (0.9) | (0.02, 4.83) | 1 | | Pinguecula | 0 (0.0) | (0.00, 3.42) | 0 | 1 (0.9) | (0.02, 4.83) | 1 | | Retinal telangiectasia | 0 (0.0) | (0.00, 3.42) | 0 | 1 (0.9) | (0.02, 4.83) | 1 | | Retinopathy | 0 (0.0) | (0.00, 3.42) | 0 | 1 (0.9) | (0.02, 4.83) | 1 | | Seidel test positive | 1 (0.9) | (0.02, 5.14) | 1 | 0 (0.0) | (0.00, 3.21) | 0 | | Vision blurred | 0 (0.0) | (0.00, 3.42) | 0 | 1 (0.9) | (0.02, 4.83) | 1 | | Visual acuity reduced | 0 (0.0) | (0.00, 3.42) | 0 | 1 (0.9) | (0.02, 4.83) | 1 | | Vitreous floaters | 0 (0.0) | (0.00, 3.42) | 0 | 1 (0.9) | (0.02, 4.83) | 1 | | Vitreous haemorrhage | 1 (0.9) | (0.02, 5.14) | 1 | 0 (0.0) | (0.00, 3.21) | 0 | If an eye has multiple occurrences of an AE, the eye is presented only once in the respective eye count column (n) for the corresponding AE. Events are counted each time in the event (E) column. N= Number of eyes in each treatment group; n= Number of eyes with event; E= Number of events; CI= Confidence Interval Percentages are calculated as (n/N)(100). The results of adverse events analyses based on the consensus definitions as set forth by the American Academy of Ophthalmology's Task Force (Masket et al. Ophthalmology 2017) are shown in Tables 17 and 18 for first and second implanted eyes, respectively. PMA P930014/S126: FDA Summary of Safety and Effectiveness Data Page 28 {28} Table 17: Supportive Characterization of Ocular Adverse Events in First Eyes based on a Modified Version of AAO Consensus (Masket et al., 2017) for AcrySof™ IQ Vivity™ and Monofocal IOL Groups (Safety Analysis Set) | | AcrySof™ IQ Vivity™ IOL First Eyes N = 107 | | | Monofocal IOL First Eyes N = 113 | | | | --- | --- | --- | --- | --- | --- | --- | | Adverse Event | n (%) | 2-sided 95% CI | E | n (%) | 2-sided 95% CI | E | | Chronic anterior uveitis | 0 (0.0) | (0.00, 3.39) | 0 | 0 (0.0) | (0.00, 3.21) | 0 | | Clinically significant cystoid | 0 (0.0) | (0.00, 3.39) | 0 | 1 (0.9) | (0.02, 4.83) | 1 | | Visually significant corneal | 0 (0.0) | (0.00, 3.39) | 0 | 0 (0.0) | (0.00, 3.21) | 0 | | Endophthalmitis | 0 (0.0) | (0.00, 3.39) | 0 | 0 (0.0) | (0.00, 3.21) | 0 | | Mechanical pupillary block | 0 (0.0) | (0.00, 3.39) | 0 | 0 (0.0) | (0.00, 3.21) | 0 | | Increased IOP | 2 (1.9) | (0.23, 6.59) | 2 | 3 (2.7) | (0.55, 7.56) | 3 | | Rhegmatogenous RD | 0 (0.0) | (0.00, 3.39) | 0 | 1 (0.9) | (0.02, 4.83) | 1 | | Toxic anterior segment | 0 (0.0) | (0.00, 3.39) | 0 | 0 (0.0) | (0.00, 3.21) | 0 | | Secondary IOL intervention – | 0 (0.0) | (0.00, 3.39) | 0 | 0 (0.0) | (0.00, 3.21) | 0 | | Secondary IOL intervention – | 0 (0.0) | (0.00, 3.39) | 0 | 1 (0.9) | (0.02, 4.83) | 1 | | Secondary IOL intervention – | 0 (0.0) | (0.00, 3.39) | 0 | 0 (0.0) | (0.00, 3.21) | 0 | Percentages are calculated as (n/N)*100; CI – confidence interval; E - Events Table 18: Supportive Characterization of Ocular Adverse Events in Second Eyes based on a Modified Version of AAO Consensus (Masket et al., 2017) for AcrySof™ IQ Vivity™ and Monofocal IOL Groups (Safety Analysis Set) | | AcrySof™ IQ Vivity™ IOL Second Eyes N = 106 | | | Monofocal IOL Second Eyes N = 113 | | | | --- | --- | --- | --- | --- | --- | --- | | Adverse Event | n (%) | 2-sided 95% CI | E | n (%) | 2-sided 95% CI | E | | Chronic anterior uveitis | 0 (0.0) | (0.00, 3.42) | 0 | 0 | (0.00, 3.21) | 0 | | Clinically significant cystoid | 0 (0.0) | (0.00, 3.42) | 0 | 0 | (0.00, 3.21) | 0 | | Visually significant corneal edema | 0 (0.0) | (0.00, 3.42) | 0 | 0 | (0.00, 3.21) | 0 | | Endophthalmitis | 0 (0.0) | (0.00, 3.42) | 0 | 0 | (0.00, 3.21) | 0 | | Mechanical pupillary block | 0 (0.0) | (0.00, 3.42) | 0 | 0 | (0.00, 3.21) | 0 | | Increased IOP | 2 (1.9) | (0.23, 6.65) | 2 | 2 | (0.22, 6.25) | 2 | | Rhegmatogenous RD | 0 (0.0) | (0.00, 3.42) | 0 | 0 | (0.00, 3.21) | 0 | | Toxic anterior segment syndrome | 0 (0.0) | (0.00, 3.42) | 0 | 0 | (0.00, 3.21) | 0 | | Secondary IOL intervention – | 0 (0.0) | (0.00, 3.42) | 0 | 0 | (0.00, 3.21) | 0 | | Secondary IOL intervention – | 0 (0.0) | (0.00, 3.42) | 0 | 0 | (0.00, 3.21) | 0 | | Secondary IOL intervention – | 0 (0.0) | (0.00, 3.42) | 0 | 0 | (0.00, 3.21) | 0 | Percentages are calculated as (n/N)*100; CI – confidence interval; E - Events PMA P930014/S126: FDA Summary of Safety and Effectiveness Data Page 29 {29} ## Device-Related Adverse Events Two eyes (both from 1 subject) out of 213 eyes implanted with the Vivity™ IOL experienced non-serious AEs of photophobia. One eye out of 226 eyes implanted with the Monofocal IOL experienced a serious AE of photopsia which subsequently led to surgical explantation of the IOL. ## Intraoperative Problems One intraoperative problem was reported during the study: an event of iris damage during second eye implantation with the Vivity™ IOL. The IOL was successfully implanted and the subject completed the study. An iris transillumination defect was noted during the slit-lamp exam for this eye at the 1 Day, 1 Month, and 6 Month visits. However, no other adverse sequelae associated with the iris damage during surgery were reported during the study. ## Contrast Sensitivity Monocular mesopic contrast sensitivity (with and without glare) was assessed at 6 months for the AcrySof™ IQ Vivity™ IOL and the Monofocal Control IOL. Data were obtained from 107 and 111 subjects in the Vivity™ and Monofocal Control IOL groups, respectively, in each arm using a backlit sine wave grating chart system (CSV1000-HGT, VectorVision, Greenville, OH). A summary of median contrast sensitivity data is depicted in Table 19. The AcrySof™ IQ Vivity™ IOL was associated with a reduction in monocular mesopic contrast sensitivity with and without glare compared to the Monofocal Control IOL, as evidenced by reductions in the median log contrast with increasing spatial frequency test condition (Table 19). Additionally, more subjects were unable to see the reference pattern at higher spatial frequencies with the AcrySof™ IQ Vivity™ IOL as compared to the Monofocal Control IOL (17.8% (n=19) vs. 3.6% (n=4) without glare and 18.7% (n=20) vs. 4.5% (n=5) with glare at 6 cpd; and 43.0% (n=46) vs. 20.7% (n=23) without glare and 52.3% (n=56) vs. 25.2% (n=28) with glare at 12 cpd). This safety concern was mitigated by professional and patient warnings regarding the reduction in contrast sensitivity. PMA P930014/S126: FDA Summary of Safety and Effectiveness Data Page 30 {30} **Table 19. Monocular Mesopic Contrast Sensitivity at 6 Months** | Spatial Frequency | IOL Group | N | Mesopic Without Glare | | | Mesopic With Glare | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | | Median (log units) | Eyes that did not see the reference pattern^{a} | | Median (log units) | Eyes that did not see the reference pattern^{a} | | | | | | | n | % | | n | % | | 1.5 Cycles Per Degree (CPD) | Vivity | 107 | 1.52 | 0 | 0.0 | 1.52 | 0 | 0.0 | | | Monofocal | 111 | 1.52 | 0 | 0.0 | 1.37 | 1 | 0.9 | | 3 Cycles Per Degree (CPD) | Vivity | 107 | 1.34 | 0 | 0.0 | 1.34 | 1 | 0.9 | | | Monofocal | 111 | 1.49 | 1 | 0.9 | 1.49 | 1 | 0.9 | | 6 Cycles Per Degree (CPD) | Vivity | 107 | 1.38 | 19 | 17.8 | 1.38 | 20 | 18.7 | | | Monofocal | 111 | 1.55 | 4 | 3.6 | 1.55 | 5 | 4.5 | | 12 Cycles Per Degree (CPD) | Vivity | 107 | 0.61 | 46 | 43.0 | ≤0.61 | 56 | 52.3 | | | Monofocal | 111 | 0.91 | 23 | 20.7 | 0.91 | 28 | 25.2 | $^{a}$Number of eyes unable to see a target spatial frequency at any available contrast ### Low Contrast Visual Acuity Monocular (first implanted eye) low contrast visual acuity assessments were performed using 10% and 25% low contrast visual acuity computerized logMAR charts. Best corrected visual acuity at distance (4 m) and distance corrected visual acuity at Intermediate (66 cm) and Near (40 cm) were tested under photopic conditions, with results depicted in Table 20. Differences in mean best corrected distance visual acuity between the 2 groups for both contrast levels were approximately 1 line or less. Greater than 1 line improvements in intermediate visual acuity (improvement of 0.132 logMAR and 0.141 logMAR at 10% and 25% contrast respectively) and near visual acuity (improvement of 0.118 logMAR and 0.137 logMAR) were observed for the Vivity™ IOL over the Monofocal Control IOL, at both contrast levels. PMA P930014/S126: FDA Summary of Safety and Effectiveness Data Page 31 {31} **Table 20: Summary of Monocular, Photopic, Low Contrast Distance, Intermediate, and Near VAs by Test Condition and IOL Group** | Test Condition | IOL Group | Monocular, Photopic, Low Contrast VA (Mean logMAR, Approximate Snellen Line Equivalent) | | | | --- | --- | --- | --- | --- | | | | Distance | Intermediate (66 cm) | Near (40 cm) | | 10% Contrast | Vivity IOL | 0.393, 20/50 | 0.534, 20/63 | 0.764, 20/125 | | | Monofocal Control IOL | 0.281, 20/40 | 0.666, 20/100 | 0.882, 20/160 | | 25% Contrast | Vivity IOL | 0.223, 20/32 | 0.372, 20/50 | 0.593, 20/80 | | | Monofocal Control IOL | 0.137, 20/25 | 0.513, 20/63 | 0.730, 20/100 | ### **Visual Disturbances** A Patient Reported Outcome Measure instrument was developed and validated for use in this clinical study to assess visual disturbances. Subjects who reported experiencing a particular visual disturbance (glare, halos, starbursts, hazy vision, blurred vision, double vision in one or both eyes, color distortion, or peripheral dark area) were asked to rate the severity (“none”, “a little”, “mild”, “moderate”, “severe”), frequency (“never”, “rarely”, “sometimes”, “most of the time”, “always”), and bothersomeness (“not at all”, “a little bit”, “somewhat”, “quite a bit”, “very much”) of the disturbance. A subject may report multiple symptoms. As demonstrated in Tables 21 and 22, rates of reports of severe or very bothersome visual disturbances/distortions were low (< 4%) for the AcrySof™ IQ Vivity™ IOL and the monofocal control IOL (< 3%) groups at 6 months. PMA P930014/S126: FDA Summary of Safety and Effectiveness Data Page 32 {32} **Table 21: Comparison of Visual Disturbance Bothersomeness for AcrySof™ IQ Vivity™ IOL and Monofocal Control IOL 6 months Postoperative (following second eye implantation)** | Visual Disturbance | AcrySof IQ Vivity IOL N = 106 | | | | | | Monofocal Control IOL N = 113 | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | Total (N) | Not at all bothered^{A} n (%) | A Little bit % | Some what % | Quite a bit % | Very much % | Total (N) | Not at all bothered^{A} % | A Little bit % | Some what % | Quite a bit % | Very much % | | Starbursts | 106 | 78 (73.6) | 15 (14.2) | 10 (9.4) | 1 (0.9) | 2 (1.9) | 110 | 79 (71.8) | 16 (14.5) | 12 (10.9) | 2 (1.8) | 1 (0.9) | | Halos | 106 | 88 (83.0) | 13 (12.3) | 3 (2.8) | 1 (0.9) | 1 (0.9) | 110 | 98 (89.1) | 6 (5.5) | 5 (4.5) | 1 (0.9) | 0 (0.0) | | Glare | 105 | 82 (78.1) | 12 (11.4) | 7 (6.7) | 4 (3.8) | 0 (0.0) | 111 | 75.7 (84) | 11 (9.9) | 13 (11.7) | 3 (2.7) | 0 (0.0) | | Hazy Vision | 105 | 94 (89.5) | 5 (4.8) | 3 (2.9) | 3 (2.9) | 0 (0.0) | 111 | 98 (88.3) | 4 (3.6) | 7 (6.3) | 2 (1.8) | 0 (0.0) | | Blurred Vision | 106 | 97 (91.5) | 0 (0.0) | 5 (4.7) | 3 (2.8) | 1 (0.9) | 111 | 89 (80.2) | 10 (9.0) | 8 (7.2) | 2 (1.8) | 2 (1.8) | | Double Vision | 106 | 104 (98.1) | 1 (0.9) | 1 (0.9) | 0 (0.0) | 0 (0.0) | 111 | 110 (99.1) | 0 (0.0) | 1 (0.9) | 0 (0.0) | 0 (0.0) | | Dark Area *Negative Dysphotopsia* | 106 | 98 (92.5) | 6 (5.7) | 0 (0.0) | 1 (0.9) | 1 (0.9) | 111 | 100 (90.1) | 6 (5.4) | 3 (2.7) | 1 (0.9) | 1 (0.9) | $^{A}$ Includes subjects who did not experience the disturbance and those reporting being not at all bothered PMA P930014/S126: FDA Summary of Safety and Effectiveness Data Page 33 {33} **Table 22: Comparison of Visual Disturbance Severity for AcrySof™ IQ Vivity™ IOL and Monofocal Control IOL 6 months Postoperative (following second eye implantation)** | Visual Disturbance | AcrySof™ IQ Vivity™ IOL N = 106 | | | | | | Monofocal Control IOL N = 113 | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | Total (N) | None^{a} n (%) | A Little n (%) | Mild n (%) | Moderate n (%) | Severe n (%) | Total (N) | None^{a} n (%) | A Little n (%) | Mild n (%) | Moderate n (%) | Severe n (%) | | | | | | | | | | | | | | | | Starbursts | 106 | 70 (66.0) | 3 (2.8) | 15 (14.2) | 14 (13.2) | 4 (3.8) | 110 | 68 (61.8) | 8 (7.3) | 18 (16.4) | 13 (11.8) | 3 (2.7) | | Halos | 106 | 78 (73.6) | 6 (5.7) | 12 (11.3) | 9 (8.5) | 1 (0.9) | 110 | 91 (82.7) | 5 (4.5) | 9 (8.2) | 4 (3.6) | 1 (0.9) | | Glare | 105 | 81 (77.1) | 0 (0.0) | 15 (14.3) | 9 (8.6) | 0 (0.0) | 111 | 81 (73.0) | 8 (7.2) | 11 (9.9) | 11 (9.9) | 0 (0.0) | | Hazy Vision | 105 | 93 (88.6) | 2 (1.9) | 5 (4.8) | 5 (4.8) | 0 (0.0) | 111 | 96 (86.5) | 3 (2.7) | 3 (2.7) | 9 (8.1) | 0 (0.0) | | Blurred Vision | 106 | 96 (90.6) | 1 (0.9) | 8 (7.5) | 1 (0.9) | 0 (0.0) | 111 | 89 (80.2) | 9 (8.1) | 10 (9.0) | 3 (2.7) | 0 (0.0) | | Double Vision | 106 | 104 (98.1) | 1 (0.9) | 1 (0.9) | 0 (0.0) | 0 (0.0) | 111 | 110 (99.1) | 0 (0.0) | 1 (0.9) | 0 (0.0) | 0 (0.0) | | Dark Area *Negative Dysphotopsia* | 106 | 96 (90.6) | 5 (4.7) | 2.8 | 1 (0.9) | 1 (0.9) | 111 | 96 (86.5) | 6 (5.4) | 7 (6.3) | 1 (0.9) | 1 (0.9) | $^{a}$ Includes subjects who did not experience the disturbance and those reporting severity of “none” ## 2. Effectiveness Results The analysis of effectiveness was based on the 107 evaluable Vivity IOL subjects and 111 evaluable control IOL subjects at the 6-month time point. Key effectiveness outcomes are presented in Tables 24 and Figures 5 and 6. ### IOL Power Calculation and Postoperative Manifest Refraction In this study, surgeons were instructed to select the lens power that targeted emmetropia (closest to 0.0D) for both the AcrySof™ IQ Vivity™ IOL and the monofocal control IOL prior to randomization. Table 23 summarizes the absolute manifest refraction spherical equivalent (MRSE) PMA P930014/S126: FDA Summary of Safety and Effectiveness Data Page 34 {34} data for AcrySof™ IQ Vivity™ IOL and monofocal control IOL subjects at 6 Months. **Table 23: Mean Absolute MRSE at 6 Months by Treatment Group** | MRSE Category | AcrySof™ IQ Vivity™ IOL | Monofocal Control IOL | | --- | --- | --- | | First Eyes N = 107 n (%) | Second Eyes N = 106 n (%) | First Eyes N = 113 n (%) | Second Eyes N = 113 n (%) | | ≤ 0.25 D | 69 (64.5) | 72 (67.9) | 63 (56.8) | 69 (62.2) | | ≤ 0.5 D | 98 (91.6) | 92 (86.8) | 96 (86.5) | 93 (83.8) | | ≤ 1.00 D | 107 (100.0) | 106 (100.0) | 108 (97.3) | 110 (99.1) | | > 1.00 D | 0 (0.0) | 0 (0.0) | 3 (2.7) | 1 (0.9) | | Total | 107 | 106 | 111 | 111 | Percentage are calculated as (n/Total)x100 ### Monocular Visual Acuity Visual Acuity was assessed under high-contrast, photopic using a computerized test system (CTS, M&S Technologies, Niles, IL). The following subsections present monocular visual acuity data collected at distance, intermediate (66 cm), and near (40 cm). Primary and secondary study endpoints included the following assessments of monocular visual acuity: - Mean monocular BCDVA, DCIVA and DCNVA by treatment group - Monocular defocus curves by treatment group These analyses are discussed in the following subsections. Monocular visual acuity was also assessed in low-contrast, photopic conditions; results of this testing is presented in the “Safety” section of this document. Table 24 presents monocular, photopic BCDVA (4 meters), DCIVA (66 cm), and DCNVA (40 cm) for first eyes treated with the AcrySof™ IQ Vivity™ or monofocal control IOLs at 6 Months. **Table 24: Comparison of Mean Monocular Photopic (First Eyes) BCDVA, DCIVA, and DCNVA Using Least Square Estimates All Implanted, 6 Months Postoperative** | Monocular Mean Visual Acuity | AcrySof™ IQ Vivity™ IOL | | | Monofocal Control IOL | | | 95% One- Sided UCL | P-Value | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | Total | Mean logMAR | Standard Error | Total | Mean logMAR | Standard Error | | | | BCDVA | 107 | 0.016 | 0.0091 | 111 | -0.036 | 0.0089 | 0.073^{a} | N/A | | DCIVA | 107 | 0.148 | 0.0120 | 111 | 0.312 | 0.0118 | N/A | < 0.001^{b} | | DCNVA | 107 | 0.359 | 0.0147 | 111 | 0.515 | 0.0144 | N/A | < 0.001^{b} | PMA P930014/S126: FDA Summary of Safety and Effectiveness Data Page 35 {35} ᵃNon-inferiority of AcrySof IQ Vivity IOL to the Monofocal Control IOL is demonstrated by the one-sided 95% Upper Confidence Limit (UCL) for treatment difference < 0.10 logMAR ᵇSuperiority of AcrySof IQ Vivity IOL over the Monofocal Control IOL is demonstrated by the upper bound of two-sided 95% CI for treatment difference is < 0.00 logMAR and p-value is less than alpha = 0.05. The AcrySof™ IQ Vivity™ IOL met the clinical performance co-primary endpoint for mean photopic BCDVA non-inferior to the monofocal control IOL (non-inferiority margin of 0.10 logMAR). The upper limit of the one-sided 95% confidence interval (CI) of the mean difference in BCDVA between IOL groups was less than 0.10 logMAR, demonstrating that the AcrySof™ IQ Vivity™ IOL is statistically non-inferior to the control lens in providing BCDVA. Additionally, the subjects implanted with the AcrySof™ IQ Vivity™ IOL in the first eyes achieved BCDVA of 0.30 logMAR or better at a rate of 99.1% and 100.0% in the AAS and Best-Case Analysis Set (BAS) set, respectively. This exceeded the ISO BCDVA Safety and Performance Endpoint (SPE) rates of 92.5% and 96.7%, respectively. The AcrySof™ IQ Vivity™ IOL provided mean photopic monocular DCIVA superior to the monofocal control IOL with an increase in 1.6 lines read and met the clinical performance co-primary endpoint with > 50% (72.9%) of first eyes achieving DCIVA of 0.20 logMAR or better at 6 Months. AcrySof™ IQ Vivity™ IOL provided mean photopic monocular DCNVA that was statistically superior to the monofocal control IOL, based on the observed 95% upper confidence limit of -0.115 logMAR for the difference in least squares means (LSMean) between the 2 groups (Model DFT015 – Model SN60WF), which was less than the upper confidence limit of 0.0 logMAR. A statistically significant difference in LSMeans of -0.156 logMAR (approximately 1.6 lines), in favor of Model DFT015, was observed with a two-sided p-value < 0.05 from a two-sample t-test (p < 0.001). In addition, 40.2% (95% CI: 30.8%, 50.1%) of AcrySof IQ Vivity IOL first eyes achieved monocular DCNVA of 0.30 logMAR or better at 6 Months, at a rate > 25% above that of the monofocal control IOL. However, this result did not meet the pre-specified performance target of ≥ 50% of AcrySof™ IQ Vivity™ IOL subjects achieving monocular DCNVA ≤ 0.30 logMAR. ### Monocular Defocus Curve Monocular defocus curves at 6 months for the AcrySof™ IQ Vivity™ IOL and the monofocal control IOL reflecting 95% confidence limits and ±1 standard deviation (SD) are depicted in Figures 5 and 6. Data were obtained from 107 and 111 subjects respectively in each arm using a PMA P930014/S126: FDA Summary of Safety and Effectiveness Data Page 36 {36} computerized visual acuity test system (CTS, M&S Technologies, Niles, IL). The Vivity™ IOL group demonstrated a mean defocus range of 1.53 D compared to 0.99 D for the Monofocal Control IOL, providing an increase of 0.54 D in depth of focus at 0.20 logMAR. Therefore, the AcrySof™ IQ Vivity™ IOL met the clinical performance co-primary endpoint, demonstrating a monocular defocus range of > 0.5 D greater than the monofocal control IOL at 0.20 logMAR at 6 Months. Figure 5: Mean Monocular (First Eyes) Defocus Curve with 95% Confidence Limits by Lens Model at 6 Months Postoperative All Implanted ![img-5.jpeg](img-5.jpeg) PMA P930014/S126: FDA Summary of Safety and Effectiveness Data Page 37 {37} Figure 6: Mean Monocular (First Eyes) Defocus Curve with ±1 SD by Lens Model at 6 Months Postoperative All Implanted ![img-6.jpeg](img-6.jpeg) Monocular defocus curves stratified by post-operative (Month 6) photopic pupil size in the Vivity and Monofocal IOL groups are presented in Figures 7 and 8, respectively. PMA P930014/S126: FDA Summary of Safety and Effectiveness Data Page 38 {38} Figure 7: Monocular Mean Defocus Curve by Post-Operative Pupil Size at 6 Months, Vivity IOL Group All Implanted ![img-7.jpeg](img-7.jpeg) PMA P930014/S126: FDA Summary of Safety and Effectiveness Data Page 39 {39} Figure 8: Monocular Mean Defocus Curve by Post-Operative Pupil Size at 6 Months, Monofocal IOL Group All Implanted ![img-8.jpeg](img-8.jpeg) # Binocular Visual Acuity Binocular visual acuities were analyzed as supportive effectiveness endpoints. Descriptive and categorical analyses of binocular uncorrected and best corrected distance visual acuities (UCDVA and BCDVA), uncorrected and distance corrected intermediate visual acuities (UCIVA and DCIVA), and uncorrected and distance corrected near visual acuities (UCNVA and DCNVA), in addition to binocular defocus curves are presented in the following subsections. Binocular mean BCDVA, UCDVA, DCIVA, UCIVA, DCNVA, and UCNVA are presented by treatment group in Table 25. One of the subjects in the AcrySof™ IQ Vivity™ IOL group was not bilaterally implanted and does not contribute to binocular assessments. PMA P930014/S126: FDA Summary of Safety and Effectiveness Data Page 40 {40} **Table 25: Comparison of Binocular Mean Photopic BCDVA, UCDVA, DCIVA, UCIVA, DCNVA, and UCNVA** **All Implanted, 6 Months Postoperative** | Binocular Mean Visual Acuity | AcrySof™ IQ Vivity™ IOL N = 106 | | | Monofocal Control IOL N = 113 | | | | --- | --- | --- | --- | --- | --- | --- | | | n | Mean logMAR | Standard Deviation | n | Mean logMAR | Standard Deviation | | BCDVA | 106 | -0.028 | 0.084 | 111 | -0.071 | 0.086 | | UCDVA | 106 | 0.035 | 0.102 | 111 | -0.022 | 0.107 | | DCIVA | 106 | 0.054 | 0.093 | 111 | 0.196 | 0.113 | | UCIVA | 106 | 0.058 | 0.083 | 111 | 0.139 | 0.122 | | DCNVA | 106 | 0.253 | 0.118 | 111 | 0.391 | 0.135 | | UCNVA | 106 | 0.208 | 0.104 | 111 | 0.339 | 0.149 | ### Binocular Categorical Visual Acuity Tables 26 and 27 present the percentage of subjects achieving binocular photopic BCDVA and UCDVA by Snellen and logMAR categories, respectively, at 6 Months. **Table 26: Binocular Photopic Distance Best Corrected and Uncorrected Visual Acuity (Snellen)** **All Implanted, 6 Months Postoperative** | Binocula…
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