TECNIS PureSee IOL, Model DEN00V TECNIS PureSee Toric II IOLs, Model DET150, DET225, DET300, DET375

P980040S176 · Johnson & Johnson Surgical Vision, Inc. · HQL · Mar 11, 2026 · Ophthalmic

Device Facts

Record IDP980040S176
Device NameTECNIS PureSee IOL, Model DEN00V TECNIS PureSee Toric II IOLs, Model DET150, DET225, DET300, DET375
ApplicantJohnson & Johnson Surgical Vision, Inc.
Product CodeHQL · Ophthalmic
Decision DateMar 11, 2026
DecisionAPPR
Regulation21 CFR 886.3600
Device ClassClass 3
AttributesTherapeutic

Indications for Use

The TECNIS SIMPLICITYTM Delivery System is used to fold and assist in inserting the TECNIS PureSeeTM IOL, which is indicated for primary implantation for the visual correction of aphakia in adult patients with less than 1 diopter of pre-existing corneal astigmatism in whom a cataractous lens has been removed. The lens mitigates the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, the TECNIS PureSeeTM IOL provides improved intermediate visual acuity, while maintaining comparable distance visual acuity. The lens is intended for capsular bag placement only. The TECNIS SIMPLICITYTM Delivery System is used to fold and assist in inserting the TECNIS PureSeeTM Toric II IOLs, which are indicated for primary implantation for the visual correction of aphakia and for reduction of refractive astigmatism in adult patients with greater than or equal to 1 diopter of preoperative corneal astigmatism in whom a cataractous lens has been removed. The lenses mitigate the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, the TECNIS PureSeeTM Toric II IOLs provide improved intermediate visual acuity, while maintaining comparable distance visual acuity. The lenses are intended for capsular bag placement only.

Device Story

TECNIS PureSee™ IOLs (non-toric and toric) are ultraviolet light-absorbing posterior chamber intraocular lenses (IOLs) designed to replace the natural crystalline lens after cataract surgery. The device uses a proprietary wavefront-designed aspheric or toric-aspheric anterior optic and a purely refractive OptiCurve™ technology on the posterior optic to create a modulated power profile, extending depth of focus to mitigate presbyopia. The lenses are preloaded in the TECNIS SIMPLICITY™ Delivery System, a sterile, single-use, touch-free disposable system for folding and insertion into the capsular bag. The device is used by ophthalmologists in a surgical setting. The JJSV TECNIS™ Toric Calculator is used to select the appropriate toric model based on patient needs. By providing improved intermediate visual acuity while maintaining distance vision, the device aims to reduce spectacle dependence for patients following cataract extraction.

Clinical Evidence

Prospective, multicenter, bilateral, controlled, masked clinical study (IDE #G240043) of 245 subjects (228 implanted). Primary endpoints: monocular DCIVA at 66 cm, depth of focus, BCDVA at 4 m, and safety (SSI rates, ISO SPE rates). Results: TECNIS PureSee™ showed statistically superior DCIVA (1.5 lines improvement, p<0.0001) and 0.64 D greater depth of focus vs. monofocal control. BCDVA was non-inferior. Safety profile met ISO 11979-7:2024 criteria; no SSIs related to optical properties. Contrast sensitivity was pupil-independent and comparable to control.

Technological Characteristics

1-piece hydrophobic acrylic IOL with UV/violet light-filtering chromophore. Optic diameter 6.0 mm, overall 13.0 mm. Features wavefront-designed aspheric (or toric-aspheric) anterior surface and refractive OptiCurve™ posterior surface. TRI-FIX haptic design. Preloaded in TECNIS SIMPLICITY™ disposable delivery system. Sterilized via ethylene oxide. Complies with ISO 11979-2, ISO 11979-3, ANSI Z80.30, and ANSI Z80.35.

Indications for Use

Indicated for primary implantation for visual correction of aphakia in adult patients following cataract removal. Non-toric models for patients with <1D pre-existing corneal astigmatism; toric models for patients with ≥1D preoperative corneal astigmatism. Provides extended depth of focus to mitigate presbyopia.

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 | Device Generic Name: | Intraocular Lens | | --- | --- | | Device Trade Name: | TECNIS PureSee™ IOL with TECNIS SIMPLICITY™ Delivery System TECNIS PureSee™ Toric II IOLs with TECNIS SIMPLICITY™ Delivery System | | Device Procode: | HQL, POE, and MJP | | Applicant's Name and Address: | Johnson & Johnson Surgical Vision, Inc. 31 Technology Drive, Suite 200, Irvine, CA 92618 USA | | Date(s) of Panel Recommendation: | None | | Premarket Approval Application (PMA) Number: | P980040/S176 | | Date of FDA Notice of Approval: | March 11, 2026 | The original PMA (PMA #P980040) was approved on February 3, 2000, for the AMO® SENSAR™ Soft Acrylic UV Light-Absorbing, Posterior Chamber IOL, Model AR40, and is indicated for the visual correction of aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag. The SSED to support the indication is available on the CDRH website and is incorporated by reference here (https://www.accessdata.fda.gov/cdrh_docs/pdf/P980040B.pdf). The current supplement was submitted to expand the indications and include the TECNIS PureSee™ IOL with TECNIS SIMPLICITY™ Delivery System (Model DEN00V) and the TECNIS PureSee™ Toric II IOL with TECNIS SIMPLICITY™ Delivery System (Models DET150, DET225, DET300, DET375). The TECNIS PureSee™ Intraocular Lenses (IOLs), consist of toric and non-toric configurations and are preloaded in TECNIS SIMPLICITY™ Delivery System. Model DEN00V is the non-toric TECNIS PureSee™ IOL, while Model Series DET150, DET225, DET300 and DET375 are the toric versions of TECNIS PureSee™ IOLs with cylinder powers of 1.50D, 2.25D, 3.00D and 3.75D, respectively. Like their parent lenses, the TECNIS PureSee™ IOLs are indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by phacoemulsification and are intended to be placed in the capsular bag. The TECNIS PureSee™ IOLs are a modification of existing FDA-approved lenses, including the SENSARTM 1-Piece IOL, Model AAB00 (P980040/S015), the TECNIS™ IOL, Model Z9000 ---FDA Summary of Safety and Effectiveness Data: P980040/S176 1 of 59 {1} (P990080/S001) and the TECNISTM 3-Piece OptiBlueTM IOL, Model ZV9003 (P980040/S035). The TECNISTM Toric 1-Piece IOL, Models ZCT150, ZCT225, ZCT300, and ZCT400 (P980040/S039; approved on April 15, 2013) is the toric parent. ## II. INDICATIONS FOR USE ### TECNIS PureSeeTM IOL with TECNIS SIMPLICITYTM Delivery System The TECNIS SIMPLICITYTM Delivery System is used to fold and assist in inserting the TECNIS PureSeeTM IOL, which is indicated for primary implantation for the visual correction of aphakia in adult patients with less than 1 diopter of pre-existing corneal astigmatism in whom a cataractous lens has been removed. The lens mitigates the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, the TECNIS PureSeeTM IOL provides improved intermediate visual acuity, while maintaining comparable distance visual acuity. The lens is intended for capsular bag placement only. ### TECNIS PureSeeTM Toric II IOLs with TECNIS SIMPLICITYTM Delivery System The TECNIS SIMPLICITYTM Delivery System is used to fold and assist in inserting the TECNIS PureSeeTM Toric II IOLs, which are indicated for primary implantation for the visual correction of aphakia and for reduction of refractive astigmatism in adult patients with greater than or equal to 1 diopter of preoperative corneal astigmatism in whom a cataractous lens has been removed. The lenses mitigate the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, the TECNIS PureSeeTM Toric II IOLs provide improved intermediate visual acuity, while maintaining comparable distance visual acuity. The lenses 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 labeling for the TECNIS PureSeeTM IOLs. ## V. DEVICE DESCRIPTION The TECNIS PureSeeTM IOLs, non-toric lens model DEN00V and toric lens Models DET150, DET225, DET300, DET375, are ultraviolet light-absorbing posterior chamber IOLs that provide extended depth of focus to mitigate the effects of presbyopia. Compared to an aspheric monofocal IOL, the lens provides substantially improved and clinically significant intermediate vision while maintaining distance visual acuity, contrast sensitivity, and low levels of visual symptoms. The lens material blocks UV and violet radiation up to a 10%T cutoff wavelength of 420 nm to 440 nm. TECNIS PureSeeTM IOLs are to be positioned in the lens capsule to replace the optical function of the natural crystalline lens. Accommodation will not be restored. **Table 1** below ---FDA Summary of Safety and Effectiveness Data: P980040/S176 2 of 59 {2} describes the physical characteristics of the lenses. The biconvex optic incorporates the proprietary wavefront-designed aspheric or toric-aspheric TECNIS anterior optic, designed to compensate for corneal spherical aberration. The anteriorly located cylinder axis marks in the toric-aspheric optic denote the meridian with the lowest power and are to be aligned with the steep corneal meridian. The toric IOLs achieved the ANSI Standard for Toric IOLs, Z80.30, rotational stability requirement (>90% of eyes having ≤5° axis change between consecutive visits). The TECNIS PureSee™ IOLs share the same one-piece lens platform, the same material, lens geometry, general dimensions, overall manufacturing process, and packaging configuration as their parent lens models, and incorporate the purely refractive OptiCurve™ technology on the posterior optic of the lens to create a modulated power profile that extends the depth of focus. The TECNIS PureSee™ IOLs demonstrated pupil-independent lens performance among the pupil sizes tested. The optic is 6.0 mm in diameter and the lens has an overall diameter of 13.0 mm. The toric lenses incorporate perpendicular maximum and minimum radii of curvature and two sets of four (total of eight) axis orientation marks on their anterior optic surfaces that correct astigmatic refractive error when aligned properly with the patient's corneal astigmatism (predicted postoperative steep corneal meridian). The physical properties of this lens are shown in Figure 1 and the packaging configurations are shown in Figure 2. The TECNIS PureSee™ IOLs packaged with the TECNIS SIMPLICITY™ Delivery System (Models DEN00V, DET150-375) are preloaded to provide a sterile, single-use, controlled and touch-free disposable system that functions as both the primary packaging and as part of an insertion system for IOL insertion into the eye during cataract surgery. The conversion table for cylinder powers is provided in the TECNIS PureSee™ IOL labeling. Light Transmittance: UV cut-off at 10% T for a spherical equivalent (SE) +5.0 diopter lens (thinnest), SE +20.0 diopter lens and a SE +34.0 diopter lens (thickest) are shown in Figure 3. The JJSV TECNIS™ Toric Calculator is a web-based calculator tool that can be used to select the most appropriate TECNIS PureSee™ Toric II IOL that best suits the visual needs of the patient. The TECNIS™ Toric Calculator is developed and controlled by JJSV's Software Development Procedures. FDA Summary of Safety and Effectiveness Data: P980040/S176 3 of 59 {3} Table 1 Summary of Technical Specifications | Attribute | TECNIS PureSee™ IOL, Model DEN00V | TECNIS PureSee™ Toric II IOLs, Models DET150-375 | | --- | --- | --- | | Lens Configuration | 1-piece lens | 1-piece lens | | Anterior Optic Profile | TECNIS wavefront-designed aspheric surface | TECNIS wavefront-designed toric-aspheric surface | | Posterior Optic Profile | Purely refractive OptiCurve™ Technology | | | Lens Material | Soft foldable hydrophobic acrylic with UVAM and proprietary violet light-filtering chromophore* | | | Index of Refraction | 1.47 at 35°C | | | Light Transmittance | UV cut-off at 10% T for a spherical equivalent (SE) +5.0 D lens (thinnest), SE +20.0 D lens and a SE +34.0 D lens (thickest) are shown in Figure 3. | | | Optic Center Thickness | 0.7 mm (+20.0 D) | | | Optic Edge Design | PROTEC 360 square posterior edge | | | Haptic Configuration | TRI-FIX design Modified C, integral with optic | TRI-FIX design Modified C, integral with optic | | Haptic Thickness | 0.46 mm | | | Cylinder Power (Diopter), IOL Plane | Spherical Equivalent (SE) Power: +5.0 D to +34.0 D in 0.5 D increments | Spherical Equivalent (SE) Power: +5.0 D to +34.0 D in 0.5 D increments Cylinder Power: Model DET150: 1.50 D Model DET225: 2.25 D Model DET300: 3.00 D Model DET375: 3.75 D (as measured at the IOL plane) | | Cylinder Power (Diopter), Corneal Plane, approximate | 0.0 | Cylinder Power: Model DET150: 1.03 D Model DET225: 1.54 D Model DET300: 2.06 D Model DET375: 2.57 D (as calculated based on the average pseudophakic eye) | *The TECNIS PureSee™ IOLs may appear slightly blue on the anterior surface under slit lamp examination, which is not detectable by patients. The violet light filter has not been shown to provide retinal phototoxicity protection. FDA Summary of Safety and Effectiveness Data: P980040/S176 4 of 59 {4} **Figure 1** **Product Drawing and photographs** | Product Drawing | TECNIS PureSee™ IOL, Model DEN00V | TECNIS PureSee™ Toric II IOLs, Model Series DET | | --- | --- | --- | | | | | **Figure 2** **TECNIS SIMPLICITY™ Packaging** ![img-0.jpeg](img-0.jpeg) FDA Summary of Safety and Effectiveness Data: P980040/S176 5 of 59 {5} Figure 3 Light Transmittance ![img-1.jpeg](img-1.jpeg) # Legend: Spectral transmittance curve of a typical 5-diopter IOL (thinnest). UV(420): UV cut-off at 10%T is 420 nm. Spectral transmittance curve of a typical 20-diopter IOL. UV(424): UV cut-off at 10%T is 424 nm. Spectral transmittance curve of a typical 34-diopter IOL (thickest). UV(426): UV cut-off at 10%T is 426 nm. Spectral transmittance curve of crystalline lenses: 30 year old and 40-49 year old from Artigas, J.M., Felipe, A., Navea, A., Fandino, A., & Artigas, C. Spectral transmission of the human crystalline lens in adult and elderly persons: color and total transmission of visible light. Invest Ophthalmol Vis Sci (2012);53(7):4076-4084. 53 year old from Boettner, E.A., and Wolter J.R. Transmission of the Ocular Media. Investigative Ophthalmology. 1962;1:776-783. ## VI. ALTERNATIVE PRACTICES AND PROCEDURES There are several other alternatives for the correction of aphakia resulting from surgical cataract removal (i.e., for patients who have had a cataractous lens removed). Nonsurgical options include eyeglasses or contact lenses. Surgical options come in the form of intraocular lenses, which may be monofocal, multifocal, extended depth of focus, full visual range, toric or accommodative, depending on the patient's needs, expectations, and lifestyle. 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. ## VII. MARKETING HISTORY The TECNIS PureSee™ IOLs in select models are currently commercially available in Australia, Canada, European Union, India, New Zealand, Singapore, and many other countries in Latin America, the Middle East-Africa region, and Asia Pacific. The lenses have not been withdrawn or recalled from any country for any reason related to safety or effectiveness. FDA Summary of Safety and Effectiveness Data: P980040/S176 6 of 59 {6} ## 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. Potential complications generally associated with cataract surgery and IOL implantation include, but are not limited to: endophthalmitis/intraocular infection, hypopyon, hyphema, IOL dislocation, persistent cystoid macular edema, pupillary block, retinal detachment/tear, persistent corneal stromal edema, persistent uveitis, persistent raised intraocular pressure (IOP) requiring treatment (e.g., AC tap), retained lens material, or toxic anterior segment syndrome, or any other adverse event that leads to permanent visual impairment or requires surgical or medical intervention to prevent permanent visual impairment. For the specific adverse events that occurred during the TECNIS PureSee™ IOL clinical study, please see Section X below. ## IX. SUMMARY OF NON-CLINICAL STUDIES Preclinical studies performed on either parent devices or subject devices demonstrate the safety and effectiveness of the TECNIS PureSee™ IOLs. The results of these studies are summarized below. ### A. Laboratory Studies #### Physicochemical Testing The TECNIS PureSee™ IOLs use the same lens material as the material parent, the TECNIS™ 3-Piece OptiBlue™ IOL, Model ZV9003 (P980040/S035); therefore, physicochemical and biological data for these associated lenses are deemed applicable to the subject devices. All physicochemical reports pertaining to the SENSAR™ violet-light filtering soft acrylic material were previously submitted to FDA in 2006 as part of the 180-Day PMA Supplement for the material parent TECNIS™ 3 Piece OptiBlue™ IOL, Model ZV9003 (P980040/S035). P980040 served as the parent lens for the P980040/S035 submission for which an SSED is available. The physicochemical characterization of the TECNIS PureSee™ IOL material met the requirements of ISO 11979-5, Ophthalmic Implants – Intraocular Lenses – Part 5: Biocompatibility and EN ISO 10993-1, Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process. The physicochemical tests are summarized in **Table 2**. All acceptance criteria for physicochemical testing were met. ---FDA Summary of Safety and Effectiveness Data: P980040/S176 7 of 59 {7} Table 2 Physicochemical Test Summary: TECNIS PureSee™ IOLs, Indicating Relationship to the SENSAR™ AR40e IOL | Physicochemical Tests | Results of Testing | | --- | --- | | Exhaustive Extraction | Pass. Equivalent to SENSAR™ soft acrylic IOL, Model AR40e (P980040) | | Leachables | Pass. Equivalent to SENSAR™ soft acrylic IOL, Model AR40e (P980040) | | Insoluble Inorganics | Pass. No hazardous components identified | | Hydrolytic Stability | Pass. Stable to 5 years equivalent age | | Photostability | Pass. Stable to 20 years equivalent age | | Nd:YAG laser | Pass. Equivalent to SENSAR™ soft acrylic IOL, Model AR40e (P980040) | Note: The SENSAR™ AR40e IOL has the OptiEdge™ design and was approved in the same PMA (P980040) as the SENSAR™ AR40 IOL, which has a rounded optic edge design. ### B. Animal Studies #### Biological Testing The TECNIS PureSee™ IOLs are made of the same soft acrylic violet-filtering material and have the same manufacturing contact materials previously qualified with the material parent, the TECNIS™ 3-Piece OptiBlue™ IOL, Model ZV9003 (P980040/S035). All physicochemical reports pertaining to the SENSAR™ violet-light filtering soft acrylic material was previously submitted to FDA in 2006 as part of the 180-Day PMA Supplement for the material parent TECNIS™ 3 Piece OptiBlue™ IOL, Model ZV9003 (P980040/S035). P980040 served as the parent lens for the P980040/S035 submission for which an SSED is available. The biocompatibility studies were performed in accordance with the requirements in ISO 10993, Biological Evaluation of Medical Devices, and 11979-5 Ophthalmic Implants – Intraocular Lenses – Part 5: Biocompatibility guidelines, to establish a complete profile of the IOL material. The results are summarized in Table 3. All acceptance criteria for biocompatibility were met. FDA Summary of Safety and Effectiveness Data: P980040/S176 8 of 59 {8} Table 3 Biocompatibility Test Summary: TECNIS PureSee™ IOL | Biological Tests | Results of Testing | | --- | --- | | Cytotoxicity: (MEM) Agar Diffusion Solid Contact & Saline Extract) | Pass Non-cytotoxic | | Percentage Inhibition of Cell Growth Method | Pass Non-inhibitory to cell growth | | Guinea Pig Maximization a. Saline Extract b. Sesame Oil Extract | Pass Non-sensitizing | | Non-Ocular Implant Study (Six-Week Subcutaneous Implantation in Rabbits) | Pass | | Six-Month Rabbit Intraocular Study | Pass | | Genotoxicity Testing (Salmonella typhimurium and Escherichia coli reverse mutation assay) | Pass Non-genotoxic, non-mutagenic | | Genotoxicity testing (chromosomal aberration assay in Chinese hamster ovary cells) Genotoxicity Testing (Mouse Lymphoma Forward Mutation Assay) | Pass Non-clastogenic Non-mutagenic under short and long exposure conditions | ### C. Additional Studies Dimensional, optical, and mechanical tests were conducted on finished, sterilized, TECNIS PureSee™ IOLs to verify the conformance to applicable sections of 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 ANSI Z80.30, American National Standard for Ophthalmics: Toric Intraocular Lenses, and ANSI Z80.35, American National Standard for Ophthalmics: Extended Depth of Focus Intraocular Lenses. As part of mechanical assessment, folding and insertion testing was also performed to verify recovery of lens properties (e.g., optical, etc.) following simulated insertion. Here, the TECNIS PureSee™ IOLs passed all predetermined requirements established in the aforementioned standards where applicable and internal product specifications. Table 4 summarizes the results of the dimensional, optical, and mechanical testing. Testing for the TECNIS SIMPLICITY™ Delivery System was completed on representative lenses and was focused on optical and mechanical testing on attributes that can be impacted by a change in the storage and delivery of the device; specifically, the recovery of properties following simulated surgical manipulation pertinent to the preloaded IOLs, according to testing requirements from ISO 11979-2 and ISO 11979-3. Here, the lenses met the acceptance criteria and met all predetermined requirements established in the aforementioned standards where applicable and internal product specifications. Table 5 summarizes the results of the recovery of properties following simulated surgical manipulation for the TECNIS SIMPLICITY™ Delivery System. FDA Summary of Safety and Effectiveness Data: P980040/S176 9 of 59 {9} **Dimensional, Optical and Mechanical Test Results** | Requirements | Results | | --- | --- | | **Optical Requirements** | | | Diopter Power | Pass | | Image Quality | Pass | | Spectral Transmittance | Pass | | Cylinder Power (TECNIS PureSee™ Toric II IOLs only) | Pass | | Axis Orientation Mark(s) (TECNIS PureSee™ Toric II IOLs only) | Pass | | **Mechanical and Dimensional Testing** | | | Overall Diameter | Pass | | Vault Height | Pass | | Sagitta | Pass | | Clear Optic diameter | Pass | | Optic Body Diameter | Pass | | Central Optic Thickness | Pass | | Axial Displacement in Compression | Pass | | Optic Decentration | Pass | | Optic Tilt | Pass | | Haptic Width | Pass | | Haptic Thickness | Pass | | Angle of Contact | Pass | | Compression Force and Decay | Pass | | Dynamic Fatigue Durability | Pass | | Pull Strength | Pass | **Recovery Properties Following Simulated Surgical Manipulation Test Results** | Requirements | Results | | --- | --- | | **Recovery of Properties Following Simulated Surgical Manipulation** | | | Diopter Power | Pass | | Cylinder Power (TECNIS PureSee™ Toric II IOLs only) | Pass | | Image Quality | Pass | | Axis Orientation Mark(s) (TECNIS PureSee™ Toric II IOLs only) | Pass | | Overall Diameter | Pass | | Sagitta | Pass | | Surface and Bulk Homogeneity | Pass | FDA Summary of Safety and Effectiveness Data: P980040/S176 10 of 59 {10} ## Microbiology, Sterilization, and Shelf-Life Adoption / Testing The lens material and platform, geometry, dimensions, manufacturing method, materials and equipment, sterilization method, and packaging materials and configuration of the TECNIS PureSee™ IOLs packaged in the TECNIS SIMPLICITY™ Delivery System are the same as those of the recent FDA-approved JJSV’s one-piece soft acrylic IOLs preloaded with the TECNIS SIMPLICITY™ Delivery System, such as TECNIS Synergy™ IOLs (P980040/S124), TECNIS Symfony™ OptiBlue™ IOLs (P980040/S142) and TECNIS Odyssey™ IOLs (P980040/S156/S159). The TECNIS Sterilization validations performed the TECNIS SIMPLICITY™ Delivery System are deemed applicable to the subject lenses and assure a minimum sterility assurance level of 10⁻⁶. A 3-year shelf life was established for the TECNIS PureSee™ IOLs packaged in the TECNIS SIMPLICITY™ Delivery System based on a 3-year shelf life approved by FDA for the TECNIS SIMPLICITY™ Delivery System in P980040/S098. These tests were conducted in accordance with the following standards, FDA Guidance, and United States Pharmacopeia (USP) chapter: - • ANSI/AAMI/ISO 11135-1, Sterilization of Healthcare Products – Ethylene Oxide – Part 1: Requirements for Development, Validation, and Routine Control of a Sterilization Process - • ISO 10993-7, Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals - • ANSI/AAMI/ISO 11737-1, Sterilization of health care products—Microbiological methods—Part 1: Determination of a population of microorganisms on products - • ANSI/AAMI ST72, Bacterial endotoxins—Test methods, routine monitoring, and alternatives to batch testing - • USP<85>, Bacterial Endotoxin Test - • FDA Guidance on Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices (2015) - • ISO 11979-6, Ophthalmic Implants – Intraocular Lenses – Part 6: Shelf-life and transport stability. - • ANSI/AAMI/ISO 11607-1, Packaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile barrier systems and packaging systems ---FDA Summary of Safety and Effectiveness Data: P980040/S176 11 of 59 {11} ## **X. SUMMARY OF PRIMARY CLINICAL STUDY(IES)** The applicant performed a clinical study to establish a reasonable assurance of safety and effectiveness of the TECNIS PureSee™ IOL with TECNIS SIMPLICITY™ Delivery System, Model DEN00V for the visual correction of aphakia in adult patients with less than 1 diopter of pre-existing corneal astigmatism in whom a cataractous lens has been removed. The lens mitigates the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, the TECNIS PureSee™ IOL provides improved intermediate visual acuity, while maintaining comparable distance visual acuity in the US under IDE #G240043. Data from this clinical study were the basis for the PMA approval decision. A summary of the clinical study is presented below. The TECNIS PureSee™ Toric II IOLs with TECNIS SIMPLICITY™ Delivery Systems (Models DET150, DET225, DET300, DET375) involved imposing the toric feature from the toric design parents (P980040/S039): TECNIS™ Toric 1-Piece IOL, Models ZCT150, ZCT225, ZCT300 and ZCT400. Since the study for TECNIS PureSee™ IOL Model DEN00V established safety and effectiveness, and the applicant has approved toric parent IOLs, additional clinical data was not required to support safety and effectiveness of the toric models. Because of the potential for an interaction between the toric and extended depth-of-focus (EDF) elements, an optical-bench study was conducted. In the optical-bench study of imaging quality, the highest-power toric IOL (DET375) was misaligned at the highest tilt, decentration, and rotation observed in the parent toric IOL study (G090251) and those modulation transfer function (MTF) measurements at appropriate spatial frequencies and defocus levels were compared to the non-toric device (DEN00V) and to a monofocal parent device. The results of the optical-bench study, as well as ray-tracing simulations performed on the highest toric power IOL (DET375), in the presence of the clinically relevant amounts of tilt, decentration and rotation expected for the TECNIS PureSee™ Toric II IOLs demonstrated that the EDF effect of the TECNIS PureSee™ IOLs is maintained in the presence of misalignment. ### **A. Study Design** Patients were treated between June 3, 2024, and April 23, 2025. The database for this Panel-Track Supplement reflected data collected through May 9, 2025, and included 245 enrolled subjects. There were 9 investigational sites. The study was a prospective, multicenter, bilateral, controlled, masked (sponsor, subject, and evaluator), randomized 6-month clinical study of the TECNIS PureSee™ IOL, with TECNIS SIMPLICITY™ Delivery System, Model DEN00V. The control group was the TECNIS™ 1-Piece IOL, with TECNIS SIMPLICITY™ Delivery System, Model DCB00. This study was designed according to ISO 11979-7:2024 and ANSI Z80.35:2018 to demonstrate the safety and effectiveness of the investigational TECNIS PureSee™ IOL in comparison to a monofocal control IOL. The TECNIS™ 1-Piece IOL, Model DCB00 used as the monofocal control is a legally marketed alternative with similar indications for use, except that it is not intended to provide improved vision at intermediate distance. ---FDA Summary of Safety and Effectiveness Data: P980040/S176 12 of 59 {12} Up to 250 subjects were to be enrolled to achieve approximately 224 bilaterally implanted subjects, to obtain approximately 200 evaluable subjects (100 subjects per IOL group) at 6 months. This was to account for a screen failure rate of approximately 10% and a dropout rate of about 10% through 6 months. The clinical hypotheses were that the investigational device TECNIS PureSee™ IOL, Model DEN00V would provide improved distance-corrected intermediate visual acuity (DCIVA, 66 cm) without compromising distance vision, when compared to the monofocal control, TECNIS™ 1-Piece IOL, Model DCB00, and that adverse event rates associated with the DEN00V IOL would be within the rates for posterior chamber IOLs given in ISO 11979-7:2024. The study sample size satisfied the requirements for a Level B modification of a parent lens per ISO 11979-7:2024 and ANSI Z80.35-2018 which requires a minimum of 100 bilaterally implanted evaluable subjects in each IOL group. In addition to satisfying the ISO sample size requirement, a total of 200 subjects evaluable at 6 months provided over 90% statistical power for comparing the IOL groups on the co-primary effectiveness endpoints of monocular DCIVA and best-corrected distance visual acuity (BCDVA) while controlling for the study Type I error rate of 0.05. # 1. Clinical Inclusion and Exclusion Criteria Enrollment in the Clinical Investigation of the Safety and Effectiveness of an Investigational Model of the TECNIS PureSee™ Intraocular Lens (Model DEN00V) study was limited to subjects who met the following inclusion criteria in each study eye: - Adults (Minimum 22 years of age or older at the time of participation in the study), - Clear intraocular media other than cataract, with BCDVA of 20/40 or worse and <1.0 D of preoperative keratometric astigmatism, - Potential BCDVA of 20/30 Snellen or better, - Availability, ability, willingness and sufficient cognitive awareness to comply with examination procedures and complete all required postoperative visits, - Signed informed consent and HIPAA authorization or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries, and - Ability to understand and respond to a questionnaire in English. Subjects were not permitted to enroll in the TECNIS PureSee™ Intraocular Lens (Model DEN00V) study if they, or either eye, met any of the following exclusion criteria: - Clinically significant ocular surface disease that would affect study measurements based on Investigator medical opinion, - Irregular corneal astigmatism, - History of intraocular surgery, including prophylactic peripheral iridotomies and peripheral laser retinal repairs, - Recent ocular trauma that is not resolved/stable or may affect visual outcomes or increase risk to the subject, - Pregnancy, planned pregnancy, presently lactating or another condition associated with hormonal fluctuation that could lead to refractive changes, FDA Summary of Safety and Effectiveness Data: P980040/S176 13 of 59 {13} - Concurrent participation or participation within 30 days prior to preoperative visit in any other clinical trial, and In addition, there were general exclusions at the time of surgery that precluded implantation of a study lens (per ISO 11979-7:2024, Section 6.10.4.2, *General exclusion criteria at the time of surgery*). If any such complications occurred during surgery, the subject was discontinued from the study (if first eye affected) or would only be followed per the protocol for the first eye (if second eye affected). ## 2. Follow-up Schedule All subjects were scheduled to return for follow-up examinations as described in **Table 6**. **Clinical Study Visit Schedule** | Visit | Eyes Evaluated | Exam | Visit Window | | --- | --- | --- | --- | | 1 | Both Eyes | Preoperative Exam | Within 60 days prior to 1^{st} surgery | | 2 | First Eye | Operative | 0-60 days after preoperative exam | | 3 | First Eye | 1 day | 1-2 days after 1^{st} eye surgery | | 4 | First Eye | 1 week | 7-14 days after 1^{st} eye surgery | | 5 | Second Eye | Operative | 7-30 days after 1^{st} eye surgery | | 6 | Second Eye | 1 day | 1-2 days after 2^{nd} eye surgery | | 7 | Second Eye | 1 week | 7-14 days after 2^{nd} eye surgery | | 8 | First Eye | 1 month^{a} | 30-60 days after 1^{st} eye surgery | | 9 | Second Eye | 1 month^{a} | 30-60 days after 2^{nd} eye surgery | | 10 | Both Eyes | 6 months^{b,c} | 120 - 180 days after 2^{nd} eye surgery | Shaded rows indicate study visits where both eyes are evaluated at the same visit $^{a}$ If the 1-month visit window for first and second eye overlap, both eyes may be examined at a single visit. $^{b}$ If for any reason the second eye is not implanted, the first eye should be examined at the 6-month study visit 120 to 180 days following the first-eye surgery. $^{c}$ A second 6-month visit (if needed) must be scheduled within 1-14 days of the first 6-month visit. Both visits must fall within the specified 6-month window (120-180 days). Following study enrollment and informed consent procedure, the preoperative assessments, included distance visual acuity, potential acuity, anterior and posterior segment examination, intraocular pressure, biometry and IOL power calculations, subject questionnaires, and ocular/medical history. Postoperatively, only the most recently operated eye was evaluated at the 1-day, 1-week and 1-month visits. Both eyes were evaluated at the 6-month visits. Postoperative measurements included FDA Summary of Safety and Effectiveness Data: P980040/S176 14 of 59 {14} manifest refraction, uncorrected and corrected visual acuities under photopic and mesopic conditions, depth of focus testing, pupil size, contrast sensitivity, keratometry, IOP measurement, dilated fundus examination, and subject questionnaires. In addition, biomicroscopic slit-lamp examination (including IOL assessment) and ocular/visual symptoms were to be assessed at all postoperative visits. Preoperatively and postoperatively, the objective parameters measured during the study are presented in Table 7. **Summary of Procedures Required at Each Visit** | Examination (Shaded lines indicate masked testing) | Preop Both eyes | Op 1^{st} eye, 2^{nd} eye | 1 day 1^{st} eye, 2^{nd} eye | 1 week 1^{st} eye, 2^{nd} eye | 1 Month 1^{st} eye, 2^{nd} eye | 6 Month Both eyes ^{1,2} | | --- | --- | --- | --- | --- | --- | --- | | Informed consent, demographics, medical and ocular history, potential visual acuity, axial length, anterior chamber depth, targeted refraction, IOL power calculations | X | | | | | | | Inclusion/exclusion criteria and randomization if required | X | | | | | | | Lens power/serial number (masked)/operative procedures | | X | | | | | | Keratometry | X | | | | | X | | Corneal Topography | X | | | | | | | UCDVA - photopic, monocular (each eye), binocular | X | | X | X | X | X | | Manifest refraction (Snellen preop; ETDRS postop) | X | | | X | X | X | | BCDVA - photopic monocular (each eye), binocular | X | | | X | X | X | | UCIVA – photopic monocular (each eye), binocular at 66 cm | | | | | X | X | | DCIVA – photopic, monocular (each eye), binocular at 66 cm | | | | | X | X | | Depth of focus testing, monocular (first eye), binocular | | | | | | X | | UCNVA – photopic, monocular (each eye), binocular at 40 cm | | | | | X | X | | DCNVA – photopic, monocular (each eye), binocular at 40 cm | | | | | X | X | | Photopic pupil size – monocular (first eyes) | | | | | | X | | Mesopic pupil size (with and without glare) – monocular (first eyes) | | | | | | X | | BCDVA- mesopic monocular (first eye), binocular | | | | | | X | | DCIVA – mesopic, monocular (first eye), binocular at 66 cm | | | | | | X | | Far Contrast sensitivity – monocular (first eye), binocular (mesopic with and without glare condition) | | | | | | X | | Biomicroscopic slit-lamp exam | X | | X | X | X | X | | Lens Stability (Tilt/Decentration) | | | X | X | X | X | | Gonioscopy | X | | | | | | | Intraocular pressure | X | | X | X | X | X | | Dilated Fundus Exam with fundus visualization and findings | X | | X | X | X | X | | Adverse event assessment | X | X | X | X | X | X | | Ocular medications | X | X | X | X | X | X | | Ocular/visual symptoms (non-directed) | X | | X | X | X | X | | Lens recommendation (self-administered) | | | | | X | X | | Subject questionnaires (PRVSQv2) (self-administered) | X | | | | X | X | FDA Summary of Safety and Effectiveness Data: P980040/S176 15 of 59 {15} ### 3. Clinical Endpoints For the remainder of the clinical summary section, “TECNIS PureSee™” refers to the TECNIS PureSee™ IOL, Model DEN00V, and “control” refers to the TECNIS™ 1-Piece IOL, Model DCB00. Of note, the numbering of endpoints below is intended to facilitate ease of reference to the results below and does not connote any statistical hierarchy. With regards to safety, the primary safety endpoints and success criteria were: 1. The incidence of secondary surgical interventions (SSIs) related to optical properties of the lens for eyes in the test lens group. 2. The incidence of all Safety and Performance Endpoints (SPE) Rates, including total SSIs as defined in ISO 11979-7:2024 for eyes in the test lens group. Success was achieved if TECNIS PureSee™ rates were not statistically significantly higher than ISO SPE rates. 3. The percentage of eyes that achieves monocular best corrected distance visual acuity (BCDVA) 0.30 LogMAR or better acuity in the test lens group, as described in ISO 11979-7:2024, at the 6-month visit. Success was achieved if the rate of eyes achieving BCDVA 0.30 LogMAR or better for the PureSee group was not statistically significantly lower than ISO SPE rates. 4. Mean monocular BCDVA at 4 meters (first eyes and all eyes). Statistical success was achieved if the PureSee group mean was statistically significantly non-inferior to that of the control by a -0.10 LogMAR margin. 5. Incidence of all other non-SPE serious adverse events (SAEs) and/or device-related adverse events (ADEs) for eyes in the test lens group. There was no success criteria as descriptive statistics were used for this endpoint. 6. Monocular mesopic contrast sensitivity without glare at 6 months (first eyes): Clinical success was achieved if the mean difference between lens groups at any spatial frequency was ≤ 0.3 log units. 7. Investigator’s assessment of his/her ability to clinically visualize fundus at 6 months. There was no success criteria as descriptive statistics were used for this endpoint. With regards to effectiveness, the primary effectiveness endpoints and success criteria were: 1. Monocular (first eyes) photopic distance-corrected intermediate visual acuity (DCIVA) at 66 cm at 6 months. The mean value for TECNIS PureSee™ group was to be statistically significantly superior to that of control group. Clinical success was achieved if the median and mean DCIVA for the PureSee group were 0.20 LogMAR or better. 2. Monocular (first eyes) distance-corrected depth of focus at 6 months. Clinical success was achieved if the intercept of the depth of focus curves at the 0.20 LogMAR threshold for the PureSee group was at least 0.50 D greater than that for the control group. 3. Monocular (first eyes) photopic BCDVA at 4 m at 6 months. The mean value for the TECNIS PureSee™ group was to be statistically significantly non-inferior to that of the control group by a 0.10 LogMAR margin. 4. Monocular (first eyes) photopic distance-corrected distance visual acuity (DCVA) at 100 cm at 6 months. Clinical success was achieved if the mean DCIVA for the TECNIS PureSee™ group was 0.20 LogMAR or better. With regard to success/failure criteria, the study success will be demonstrated if all success criteria for all primary effectiveness and primary safety endpoints are simultaneously met. FDA Summary of Safety and Effectiveness Data: P980040/S176 16 of 59 {16} Additional Study Endpoints Discussed in the Results Section Below: Manifest refraction Photopic monocular and binocular UCDVA at 4 m, UCIVA at 66 cm, UCNVA at 40 cm Photopic binocular BCDVA at 4 m, DCIVA at 66cm, DCNVA at 40 cm Photopic monocular DCNVA at 40 cm Mesopic monocular and binocular BCDVA at 4 m and DCIVA at 66 cm Binocular distance-corrected depth of focus Monocular mesopic contrast sensitivity with glare Binocular mesopic contrast sensitivity with and without glare Non-serious, non-device related adverse events Medical Findings, Lens findings Increases in Intraocular Pressure (IOP) PRO instrument (Patient Reported Visual Symptoms Questionnaire, PRVSQv2) Ocular/visual symptoms (non-directed responses as obtained from the open-ended question “Are you having any difficulties with your eyes or vision?”) PRO instrument (Patient Reported Spectacle Independence Questionnaire, PRSIQv2) The Analysis Populations were: - **Intent-to-treat (ITT) Population:** All subjects randomized with a study lens implanted in the first eye. As there were some general exclusion criteria at the time of surgery, per ISO 11979-7:2024 Section 6.10.4.2, the ITT population excluded subjects who experienced such exclusion criteria during the first-eye surgery. Subjects were analyzed per the planned randomization schema. - **Safety Population (SP):** All subjects for whom a study IOL touched the eye. Subjects were analyzed per IOL received. - **Per-Protocol (PP) Population:** Subjects implanted with a study lens, evaluated within the proper 6-month study interval and without clinically relevant protocol deviations (deviations that could potentially impact the primary endpoints), as determined prior to database lock. - **Best-Case Population:** Eyes in the safety population with no preoperative ocular pathology, no macular degeneration detected at any time, and no previous surgery for the correction of refractive error, as determined prior to database lock. The ITT Population was the primary analysis set for the primary effectiveness endpoints and the SP was the primary analysis set for the primary safety endpoints and other endpoints. In addition, the PP Population was also the primary analysis set for a primary effectiveness BCDVA endpoint. First eyes were considered the primary eyes and presented in the tables for monocular endpoints, unless specified otherwise. All results presented are based on the SP with observed case (i.e., available data with no data imputation) unless specified otherwise. ## **B. Accountability of PMA Cohort** At the time of database lock, a total of 245 subjects enrolled in the PMA study, 97.8% (223 out of the 228 bilaterally implanted) are available for analysis at the completion of the study, the 6-month FDA Summary of Safety and Effectiveness Data: P980040/S176 17 of 59 {17} post-operative visit. The study was conducted between June 2024 and April 2025 across 9 investigational sites in the USA. Of the 228 bilaterally implanted subjects in the SP population, 115 subjects were in the TECNIS PureSee™ group and 113 in the control group. Subject accountability at 6 months was 98.3% (113/115) in the TECNIS PureSee™ group (Table 8) and 97.3% (110/113) in the control group (Table 9). The PP population included 218 of 228 subjects (95.6% of SP), with 111 subjects in the TECNIS PureSee™ group and 107 in the control group. While the ITT and SP populations were comprised of 228 subjects each, the number of subjects in the TECNIS PureSee™ and control groups differed due to 1 subject who was randomized to the TECNIS PureSee™ group but was inadvertently implanted with the control lens in both eyes. All other subjects were bilaterally implanted according to the randomization schedule. Table 8 Accountability First Eyes – TECNIS PureSee™ | Status | 1 Day | | 1 Week | | 1 Month | | 6 Months^{a} | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | n | % | n | % | n | % | n | % | | **Treated (N)** | **115** | | **115** | | **115** | | **115** | | | Available for Analysis | 115 | 100.0% | 115 | 100.0% | 114 | 99.1% | 113 | 98.3% | | In Interval | 115 | 100.0% | 115 | 100.0% | 112 | 97.4% | 111 | 96.5% | | Out of Interval | 0 | 0.0% | 0 | 0.0% | 2 | 1.7% | 2 | 1.7% | | Missing Data | 0 | 0.0% | 0 | 0.0% | 1 | 0.9% | 2 | 1.7% | | o Discontinued/ early study exit | 0 | 0.0% | 0 | 0.0% | 1 | 0.9% | 2 | 1.7% | | o Lost-to-follow-up | 0 | 0.0% | 0 | 0.0% | 0 | 0.0% | 0 | 0.0% | | o Not seen but accounted for (missed visit) | 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 (ISO 11979-7:2024)^{b} | - | 100.0% | - | 100.0% | - | 100.0% | - | 100.0% | $^{a}$ Based on the first day of the 6-month visit if the visit was conducted over 2 days. $^{b}$ Percent accountability = (available for analyses * 100)/(treated - discontinued - active) FDA Summary of Safety and Effectiveness Data: P980040/S176 18 of 59 {18} **Accountability First Eyes – Control** | Status | 1 Day | | 1 Week | | 1 Month | | 6 Months^{a} | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | n | % | n | % | n | % | n | % | | **Treated (N)** | **113** | | **113** | | **113** | | **113** | | | Available for Analysis | 113 | 100.0% | 113 | 100.0% | 110 | 97.3% | 110 | 97.3% | | In Interval | 113 | 100.0% | 110 | 97.3% | 106 | 93.8% | 108 | 95.6% | | Out of Interval | 0 | 0.0% | 3 | 2.7% | 4 | 3.5% | 2 | 1.8% | | Missing Data | 0 | 0.0% | 0 | 0.0% | 3 | 2.7% | 3 | 2.7% | | o Discontinued/ early study exit | 0 | 0.0% | 0 | 0.0% | 3 | 2.7% | 3 | 2.7% | | o Lost-to-follow-up | 0 | 0.0% | 0 | 0.0% | 0 | 0.0% | 0 | 0.0% | | o Not seen but accounted for (missed visit) | 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 (ISO 11979-7:2024)^{b} | - | 100.0% | - | 100.0% | - | 100.0% | - | 100.0% | $^{a}$ Based on the first day of the 6-month visit if the visit was conducted over 2 days. $^{b}$ Percent accountability = (available for analyses * 100)/(treated - discontinued - active) ### **C. Study Population Demographics and Baseline Parameters** The demographics of the study population are typical for a cataract surgery and IOL implantation study performed in the US. **Table 10** shows the demographic results for the SP population. The population was on average 68.5 (Standard Deviation [SD] of 6.7) years of age with 77.2% (176/228) of subjects 65 years or older. Most subjects were female (61.8%; 141/228) and white (81.1%; 185/228) with brown/black irises (54.4%; 124/228). Similar demographic characteristics were observed for age, sex, race, ethnicity, or iris color between lens groups. Additionally, the demographic characteristics were similar for the ITT and PP populations. FDA Summary of Safety and Effectiveness Data: P980040/S176 19 of 59 {19} **Demographics – TECNIS PureSee™ and Control Subjects** | | | TECNIS PureSee™ N=115 | | Control N=113 | | Total (N=228) | | | --- | --- | --- | --- | --- | --- | --- | --- | | Age (years) | N | 115 | | 113 | | 228 | | | | Mean | 69.0 | | 68.0 | | 68.5 | | | | SD | 6.9 | | 6.4 | | 6.7 | | | | Median | 70.0 | | 68.0 | | 69.0 | | | | Min | 45 | | 44 | | 44 | | | | Max | 82 | | 84 | | 84 | | | | | **n** | **%** | **n** | **%** | **n** | **%** | | Age Group | <65 years | 25 | 21.7% | 27 | 23.9% | 52 | 22.8% | | | >=65years | 90 | 78.3% | 86 | 76.1% | 176 | 77.2% | | | Total n | 115 | 100.0% | 113 | 100.0% | 228 | 100.0% | | Sex | Male | 44 | 38.3% | 43 | 38.1% | 87 | 38.2% | | | Female | 71 | 61.7% | 70 | 61.9% | 141 | 61.8% | | | Total n | 115 | 100.0% | 113 | 100.0% | 228 | 100.0% | | Race | American Indian/Alaska Native | 0 | 0.0% | 1 | 0.9% | 1 | 0.4% | | | Asian (Includes Indian) | 5 | 4.3% | 3 | 2.7% | 8 | 3.5% | | | Black or African American | 13 | 11.3% | 16 | 14.2% | 29 | 12.7% | | | Native Hawaiian/Other Pacific Islander | 1 | 0.9% | 0 | 0.0% | 1 | 0.4% | | | White | 93 | 80.9% | 92 | 81.4% | 185 | 81.1% | | | Other | 3 | 2.6% | 1 | 0.9% | 4 | 1.8% | | | Total n | 115 | 100.0% | 113 | 100.0% | 228 | 100.0% | | Ethnicity | Hispanic/Latino | 18 | 15.7% | 10 | 8.8% | 28 | 12.3% | | | Not Hispanic/Latino | 97 | 84.3% | 103 | 91.2% | 200 | 87.7% | | | Total n | 115 | 100.0% | 113 | 100.0% | 228 | 100.0% | | Iris Color | Blue/Gray | 35 | 30.4% | 23 | 20.4% | 58 | 25.4% | | | Brown/Black | 61 | 53.0% | 63 | 55.8% | 124 | 54.4% | | | Green/Hazel | 19 | 16.5% | 27 | 23.9% | 46 | 20.2% | | | Total n | 115 | 100.0% | 113 | 100.0% | 228 | 100.0% | %=n/N *100 (Total N - Not Reported) **Table 11** presents the preoperative MRSE and Keratometric Cylinder for TECNIS PureSee™ and control subjects in the SP population. The mean differences between lens groups for preoperative intended MRSE and preoperative keratometric cylinder were small and not clinically significant (difference of 0.02 D and -0.01 D, respectively). These results were similar for the ITT and PP populations. FDA Summary of Safety and Effectiveness Data: P980040/S176 20 of 59 {20} Table 11 Mean Intended MRSE and Preoperative Keratometric Cylinder First Eyes | Variable | IOL | n | Mean | Standard Deviation | Median | Minimum | Maximum | | --- | --- | --- | --- | --- | --- | --- | --- | | Intended MRSE (D) | TECNIS PureSee™ | 115 | -0.06 | 0.104 | -0.04 | -0.32 | 0.19 | | | Control | 113 | -0.08 | 0.111 | -0.08 | -0.35 | 0.23 | | | Difference | | 0.02 | | | | | | Keratometric Cylinder (D) | TECNIS PureSee™ | 115 | 0.51 | 0.244 | 0.54 | 0.00 | 0.98 | | | Control | 113 | 0.51 | 0.232 | 0.51 | 0.00 | 1.00 | | | Difference | | -0.01 | | | | | ### D. Safety and Effectiveness Results #### 1. Safety Results The analysis of safety results was based on the SP cohort of 228 subjects treated, 223 were available for the 6-month evaluation. The primary analysis sets for all primary safety endpoints were the SP first eyes and all eyes, except for contrast sensitivity which was SP first eyes only. The SP was also the primary analysis set for the other safety endpoints reported. In addition, the Best-Case population first eyes was also a primary analysis set for the BCDVA vs ISO Safety and Performance (SPE) rate endpoint. The success criteria for all primary safety endpoints were met for the TECNIS PureSee™ lens. The key safety outcomes for this study are presented below in Tables 12-24, Figures 4-7. Adverse effects are reported in Tables 12-18. **Adverse effects that occurred in the PMA clinical study:** The second co-primary safety endpoint was persistent (present at the final visit) and cumulative rates of ISO 11979-7 SPE AEs among first eyes and all eyes in the TECNIS PureSee™ lens group. This primary safety endpoint met the study success criteria because the rates were below or not statistically significantly higher than the ISO SPE rates (Table 12 and Table 13). Overall, there were 2 SAEs in first eyes and 3 SAEs in all eyes associated with ISO SPEs. FDA Summary of Safety and Effectiveness Data: P980040/S176 21 of 59 {21} **Table 12** **6-Month Persistent Adverse Events vs. ISO 11979-7 SPEᵃ Rates** **TECNIS PureSee™ Group** | Persistent Medical Complication/Adverse Event | ISO SPE Rate | First Eyes N=113 | | All Eyes N=226 | | | --- | --- | --- | --- | --- | --- | | | % | n (%) | Lower Bound of 1-sided 95% CI | n (%) | Lower Bound of 1-sided 95% CI | | Corneal edema | 0.3 | 0 (0.0%) | 0.00 | 0 (0.0%) | 0.00 | | Cystoid macular edema | 0.5 | 1 (0.9%) | 0.05 | 2 (0.9%) | 0.16 | | Iritis | 0.3 | 0 (0.0%) | 0.00 | 0 (0.0%) | 0.00 | | Raised IOP requiring treatment | 0.4 | 0 (0.0%) | 0.00 | 0 (0.0%) | 0.00 | ᵃ SPE: Safety and Performance Endpoint. Confidence intervals were calculated using the Clopper-Pearson method. **Table 13** **6-Month Cumulative Adverse Events vs. ISO 11979-7 SPEᵃ Rates** **TECNIS PureSee™ Group** | Cumulative Medical Complication/Adverse Event | ISO SPE Rate | First Eyes N=115 | | All Eyes N=230 | | | --- | --- | --- | --- | --- | --- | | | % | n (%) | Lower Bound of 1-sided 95% CI | n (%) | Lower Bound of 1-sided 95% CI | | Cystoid macular edemaᵇ | 3.0 | 1 (0.9%) | 0.04 | 3 (1.3%) | 0.36 | | Hypopyon | 0.3 | 0 (0.0%) | 0.00 | 0 (0.0%) | 0.00 | | Endophthalmitis | 0.1 | 0 (0.0%) | 0.00 | 0 (0.0%) | 0.00 | | Lens dislocated from posterior chamber | 0.1 | 0 (0.0%) | 0.00 | 0 (0.0%) | 0.00 | | Pupillary block | 0.1 | 0 (0.0%) | 0.00 | 0 (0.0%) | 0.00 | | Retinal detachment | 0.3 | 0 (0.0%) | 0.00 | 0 (0.0%) | 0.00 | | Eyes with secondary surgical interventionᶜ | 0.8 | 1 (0.9%) | 0.04 | 1 (0.4%) | 0.02 | | o Device related | - | 0 (0.0%) | 0.00 | 0 (0.0%) | 0.00 | | o Not device related | - | 1 (0.9%) | 0.04 | 1 (0.4%) | 0.02 | % = (n/N) *100 ᵃ SPE: Safety and Performance Endpoint. ᵇ All incidence of cystoid macular edema reported per ISO, regardless of clinical significance as defined by Masket et al. AAO Task Force criteria. ᶜ Excluding wound burp. Confidence intervals were calculated using the Clopper-Pearson method. The first co-primary safety endpoint was SSIs related to the optical properties of the IOL and during the pivotal trial there were zero SSIs related to the optical properties of the IOL (i.e., “Eyes with secondary surgical intervention, device related”) (Table 14). In addition, SSIs not related to the optical properties of the IOL, including non-ISO SPE SSIs procedures (such as tap, wound burp, and paracentesis) are listed in Table 14. FDA Summary of Safety and Effectiveness Data: P980040/S176 22 of 59 {22} **Table 14** Secondary Surgical Interventions by IOL Group | | TECNIS PureSee™ | | | | Control | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | First Eyes N=115 | | All Eyes N=230 | | First Eyes N=113 | | All Eyes N=226 | | | | n | % | n | % | n | % | n | % | | **Secondary Surgical Interventions (SSIs)** | | | | | | | | | | ○ Anterior chamber washout for retained lens material | 1 | 0.9% | 1 | 0.4% | 0 | 0.0% | 0 | 0.0% | | ○ Wound burp | 0 | 0.0% | 2 | 0.9% | 2 | 1.8% | 3 | 1.3% | | ○ Pars plana vitrectomy for vitreous in the anterior chamber | 0 | 0.0% | 0 | 0.0% | 0 | 0.0% | 1 | 0.4% | | ○ Related to Optical Properties | 0 | 0.0% | 0 | 0.0% | 0 | 0.0% | 0 | 0.0% | | **Total Eyes with SSIs** | **1** | **0.9%** | **3** | **1.3%** | **2** | **1.8%** | **4** | **1.8%** | % = (n/N) *100 The incidence of all other non-SPE serious AEs and/or device-related adverse events for eyes in the test lens group was the fifth co-primary safety endpoint. A summary of the results is described below and in **Table 15** and **Table 16**. In the TECNIS PureSee™ group, the incidence rates of non-SPE ocular serious and/or device-related adverse events were 4.3% (5/115) for first eyes and 4.8% (11/230) for all eyes. - Non-SPE SAEs: 1.7% (2/115) of TECNIS PureSee™ first eyes and 2.6% (6/230) of all eyes experienced increased intraocular pressure (IOP), deemed as serious but non-device related; all events were resolved without sequelae. - Non-SPE ADEs: 2.6% (3/115) of TECNIS PureSee™ first eyes and 2.2% (5/230) of all eyes reported undesirable optical phenomena (or inadequate visual clarity) deemed device-related but non-serious; of these, 4 (from 2 subjects) from the all-eyes set were ongoing at study end. Only 1 of 115 (0.9%) subject in the TECNIS PureSee™ group reported optical phenomena to cause bother or difficulty that interfered with daily activity for more than 3 months. FDA Summary of Safety and Effectiveness Data: P980040/S176 23 of 59 {23} **Table 15** **Ocular Non-SPE Related Serious and/or Device-Related Adverse Events** **Safety Population - First Eyes** | Adverse Event | DEN00V N=115 | | Control N=113 | | | --- | --- | --- | --- | --- | | | n (%) | 95% CI | n (%) | 95% CI | | Inadequate visual clarity | 1 (0.9) | (0.02, 4.75) | 0 (0.0) | (0.00, 3.21) | | Increased IOP | 2 (1.7) | (0.21, 6.14) | 3 (2.7) | (0.55, 7.56) | | Undesirable optical phenomena | 2 (1.7) | (0.21, 6.14) | 3 (2.7) | (0.55, 7.56) | | Total^{a} | 5 (4.3) | (1.43, 9.85) | 6 (5.3) | (1.97, 11.20) | Confidence intervals are calculated using the Clopper-Pearson method. $^{a}$ Total represents the number of unique eyes with at least 1 event. **Table 16** **Ocular Non-SPE Related Serious and/or Device-Related Adverse Events** **Safety Population - All Eyes** | Adverse Event | DEN00V N=230 | | Control N=226 | | | --- | --- | --- | --- | --- | | | n (%) | 95% CI | n (%) | 95% CI | | Inadequate visual clarity | 2 (0.9) | (0.11, 3.11) | 0 (0.0) | (0.00, 1.62) | | Increased IOP | 6 (2.6) | (0.96, 5.59) | 4 (1.8) | (0.48, 4.47) | | Undesirable optical phenomena | 3 (1.3) | (0.27, 3.76) | 6 (2.7) | (0.98, 5.69) | | Total^{a} | 11 (4.8) | (2.41, 8.40) | 10 (4.4) | (2.14, 7.99) | Confidence intervals are calculated using the Clopper-Pearson method. $^{a}$ Total represents the number of unique eyes with at least 1 event. Additional safety measurements based on the modified consensus definitions as set forth by the American Academy of Ophthalmology's Task Force (Masket et al., Ophthalmology 2017) are shown in **Table 17**. FDA Summary of Safety and Effectiveness Data: P980040/S176 24 of 59 {24} **Ocular Adverse Events Based on a Modified Version of the AAO Task Force Consensus** | Adverse Event | First Eyes | All Eyes | Subjects | | --- | --- | --- | --- | | TECNIS PureSee™ N=115 n (%) | Control N=113 n (%) | TECNIS PureSee™ N=230 n (%) | Control N=226 n (%) | TECNIS PureSee™ N=115 n (%) | Control N=113 n (%) | | Increased IOP | 3 (2.6) | 7 (6.2) | 7 (3.0) | 9 (4.0) | 6 (5.2) | 8 (7.1) | | Chronic anterior uveitis | 2 (1.7) | 0 (0.0) | 3 (1.3) | 0 (0.0) | 3 (2.6) | 0 (0.0) | | Clinically significant cystoid macular edema | 0 (0.0) | 1 (0.9) | 0 (0.0) | 2 (0.9) | 0 (0.0) | 2 (1.8) | | Corneal edema | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | | Toxic anterior segment syndrome | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | | Endophthalmitis | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | | Mechanical pupillary block | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | | Rhegmatogenous RD | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | | Secondary IOL intervention | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | | Exchange | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | | Removal | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | | Reposition | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | % = n/N Adverse Events are presented in descending order by the incidence rate of TECNIS PureSee™ first eyes. n=Number of unique eyes or unique subject. **Table 18** presents the incidence rates of medical findings/general AEs for the TECNIS PureSee™ and control all-eyes at 6 months. The most reported medical findings for all eyes in both IOL groups were posterior vitreous detachment/floaters and posterior capsule opacification (PCO). Of the reports of PCO (any), most were of trace severity and there were no cases of moderate or severe PCO were reported in either IOL group. **Medical Findings/Adverse Events at 6 Months** | Medical Finding | TECNIS PureSee™ N=226 | | Control N=220 | | | --- | --- | --- | --- | --- | | | n | % | n | % | | Posterior vitreous detachment/floaters | 99 | 43.8% | 77 | 35.0% | | Posterior capsule opacification (any) | 69 | 30.5% | 80 | 36.4% | | o Trace | 65 | 28.8% | 73 | 33.2% | | o Mild | 4 | 1.8% | 7 | 3.2% | | o Moderate | 0 | 0.0% | 0 | 0.0% | | o Severe | 0 | 0.0% | 0 | 0.0% | | Blepharitis/meibomianitis | 60 | 26.5% | 54 | 24.5% | | Dermatochalasis | 56 | 24.8% | 48 | 21.8% | | Dry eye/superficial punctate keratopathy/punctate epithelial erosion/tear film insufficiency | 29 | 12.8% | 16 | 7.3% | | Pinguecula | 19 | 8.4% | 25 | 11.4% | | Arcus | 16 | 7.1% | 15 | 6.8% | FDA Summary of Safety and Effectiveness Data: P980040/S176 25 of 59 {25} | Medical Finding | TECNIS PureSee™ N=226 | | Control N=220 | | | --- | --- | --- | --- | --- | | | n | % | n | % | | Posterior capsule striae/wrinkles | 15 | 6.6% | 11 | 5.0% | | Peripapillary atrophy | 9 | 4.0% | 7 | 3.2% | | Meibomian gland dysfunction | 8 | 3.5% | 4 | 1.8% | | Corneal scar | 5 | 2.2% | 9 | 4.1% | | Epiretinal membrane | 5 | 2.2% | 8 | 3.6% | | Ptosis | 5 | 2.2% | 5 | 2.3% | | Drusen | 4 | 1.8% | 14 | 6.4% | | Intra-ocular injection | 4 | 1.8% | 0 | 0.0% | | Retinal pigment epithelium (RPE) changes | 4 | 1.8% | 9 | 4.1% | | Telangiectasia | 4 | 1.8% | 4 | 1.8% | | Corneal dystrophy | 3 | 1.3% | 2 | 0.9% | | Corneal pigmentation | 3 | 1.3% | 2 | 0.9% | | Eye naevus | 3 | 1.3% | 2 | 0.9% | | Posterior capsule reticulation | 3 | 1.3% | 9 | 4.1% | | Pterygium | 3 | 1.3% | 2 | 0.9% | | Strabismus | 3 | 1.3% | 0 | 0.0% | | Blepharal papilloma | 2 | 0.9% | 0 | 0.0% | | Cystoid macular edema | 2 | 0.9% | 1 | 0.5% | | Diabetic retinopathy | 2 | 0.9% | 0 | 0.0% | | Guttata | 2 | 0.9% | 1 | 0.5% | | Lens disorder | 2 | 0.9% | 0 | 0.0% | | Melanosis | 2 | 0.9% | 0 | 0.0% | | Optic disc pigmentation | 2 | 0.9% | 0 | 0.0% | | Punctal plug insertion | 2 | 0.9% | 0 | 0.0% | | Retinal aneurysm | 2 | 0.9% | 0 | 0.0% | | Retinal degeneration | 2 | 0.9% | 5 | 2.3% | | Retinal detachment/tear | 2 | 0.9% | 0 | 0.0% | FDA Summary of Safety and Effectiveness Data: P980040/S176 26 of 59 {26} | Medical Finding | TECNIS PureSee™ N=226 | | Control N=220 | | | --- | --- | --- | --- | --- | | | n | % | n | % | | Rosacea | 2 | 0.9% | 0 | 0.0% | | Choroidal dystrophy | 1 | 0.4% | 0 | 0.0% | | Corneal deposits | 1 | 0.4% | 0 | 0.0% | | Cranial nerve paralysis | 1 | 0.4% | 0 | 0.0% | | Hyalosis asteroid | 1 | 0.4% | 0 | 0.0% | | Iris atrophy/abnormality | 1 | 0.4% | 0 | 0.0% | | Retinal scar | 1 | 0.4% | 1 | 0.5% | | Scleral disorder | 1 | 0.4% | 0 | 0.0% | | Chorioretinal scar | 0 | 0.0% | 1 | 0.5% | | Conjunctivochalasis | 0 | 0.0% | 2 | 0.9% | | Cornea verticillata | 0 | 0.0% | 2 | 0.9% | | Macular atrophy | 0 | 0.0% | 1 | 0.5% | | Macular degeneration | 0 | 0.0% | 4 | 1.8% | | Maculopathy | 0 | 0.0% | 1 | 0.5% | | Optic atrophy | 0 | 0.0% | 1 | 0.5% | | Pigment | 0 | 0.0% | 2 | 0.9% | | Retinal pigmentation | 0 | 0.0% | 1 | 0.5% | | Retinal vascular disorder | 0 | 0.0% | 1 | 0.5% | | Steatoblepharon | 0 | 0.0% | 2 | 0.9% | | Vitreous adhesions | 0 | 0.0% | 1 | 0.5% | | Vitreous degeneration | 0 | 0.0% | 3 | 1.4% | Only findings reported with an incidence >0 are presented. % = (n/N) *100 N=Number of all eyes (first and second). ### Visual Acuity Related Primary Safety Endpoints The third co-primary safety endpoint was the percentage of eyes achieving BCDVA 0.30 logMAR or better acuity in the test lens group, as described in ISO 11979-7:2024, at the 6-month visit. The success criterion for the primary safety endpoint was achieved, as 100% of first eyes and all eyes in the safety population and 100% of first eyes in the best-case population achieved BCDVA 0.30 LogMAR (Table 19). FDA Summary of Safety and Effectiveness Data: P980040/S176 27 of 59 {27} **Monocular Best-Corrected Distance Visual Acuity of 0.30 LogMAR or Better at 6 Months vs ISO 11979-7 SPE$^{a}$ Rates** | Analysis Population | Cohort | LogMAR Threshold | ISO SPE (%) | n (%) | Upper bound of 1-sided 95% CI | | --- | --- | --- | --- | --- | --- | | Safety Population | First Eyes (N=113) | ≤0.30 | 92.5 | 113 (100.0) | 100.00 | | | All Eyes (N=226) | ≤0.30 | 92.5 | 226 (100.0) | 100.00 | | Best Case Population | First Eyes (N=112) | ≤0.30 | 96.7 | 112 (100.0) | 100.00 | $^{a}$ SPE: Safety and Performance Endpoint. Confidence intervals are calculated using the Clopper-Pearson method. The fourth co-primary endpoint was mean monocular photopic BCDVA where distance is defined as 4 meters. The results demonstrated that the test lens group was non-inferior to the control lens group by -0.10 logMAR margin, at the 6-month visit. Among first eyes in the SP at 6 months, the difference in mean monocular BCDVA between lens groups was -0.04 LogMAR. The lower limit of the 2-sided 90% CI of the mean difference was -0.06, which was greater than the -0.10 LogMAR non-inferiority margin; thus, the statistical success criterion of this primary safety endpoint was met. Similar to the first-eye results, for all eyes in the SP at 6 months, the difference in mean monocular (all-eye) BCDVA between lens groups was -0.04 LogMAR. The lower limit of the 2-sided 90% CI of the mean difference was -0.05, which was greater than the -0.10 LogMAR non-inferiority margin; thus, the statistical success criterion of this primary safety endpoint was also met (Table 20). **Monocular Best-Corrected Distance Visual Acuity at 4 m at 6 Months Safety Population** | Cohort | Lens Group | N | Mean Monocular LogMAR | Monocular Snellen Equiv. | 90% CI | | --- | --- | --- | --- | --- | --- | | First Eyes | TECNIS PureSee™ | 113 | -0.04 | 20/18 | (-0.05, -0.03) | | | Control | 110 | -0.08 | 20/16 | (-0.09, -0.06) | | | Difference | | -0.04 | -0.4 lines^{a} | (-0.06, -0.02) | | All Eyes (first and second) | TECNIS PureSee™ | 226 | -0.04 | 20/18 | (-0.05, -0.03) | | | Control | 220 | -0.08 | 20/16 | (-0.09, -0.07) | | | Difference | | -0.04 | -0.4 lines^{a} | (-0.05, -0.03) | $^{a}$ Line difference (Control minus TECNIS PureSee™) converted directly from LogMAR difference. Non-inferiority margin of -0.10 LogMAR. ## Mesopic Contrast Sensitivity The between-lens groups differences (Figure 4 and Table 21) in mean monocular (first eye) contrast sensitivity (CS) values under mesopic conditions without glare were ≤0.3 log units at all spatial frequencies, meeting the clinical success criterion of the sixth co-primary safety endpoint according to ISO 11979-7:2024. Likewise, the median differences were ≤0.3 log units at all spatial FDA Summary of Safety and Effectiveness Data: P980040/S176 28 of 59 {28} frequencies. All subjects (100.0%) in both lens groups were able to see the reference pattern for the contrast sensitivity tests at all tested conditions. Similar to the monocular mesopic without glare CS outcomes, the between-lens group mean and median differences in both monocular CS with glare (Figure 4 and Table 21) and binocular CS with and without glare (Figure 5) under mesopic conditions were ≤0.3 log units at all spatial frequencies. **Monocular Best Corrected Distance Mesopic Contrast Sensitivity (Log Unit) at 6 Months** | Spatial Frequency | Lens Model | N | Without Glare | | With Glare | | | --- | --- | --- | --- | --- | --- | --- | | | | | Did not see reference pattern | | Did not see reference pattern | | | | | | Mean | % | Mean | % | | **1.5 cpd** | TECNIS PureSee™ | 113 | 1.95 | 0.0% | 1.73 | 0.0% | | | Control | 110 | 1.91 | 0.0% | 1.75 | 0.0% | | | Difference | | 0.04 | | -0.02 | | | **3.0 cpd** | TECNIS PureSee™ | 113 | 2.00 | 0.0% | 1.81 | 0.0% | | | Control | 110 | 2.01 | 0.0% | 1.88 | 0.0% | | | Difference | | -0.01 | | -0.08 | | | **6.0 cpd** | TECNIS PureSee™ | 113 | 1.65 | 0.0% | 1.50 | 0.0% | | | Control | 110 | 1.75 | 0.0% | 1.70 | 0.0% | | | Difference | | -0.10 | | -0.20 | | | **12.0 cpd** | TECNIS PureSee™ | 113 | 0.98 | 0.0% | 0.88 | 0.0% | | | Control | 110 | 1.11 | 0.0% | 1.06 | 0.0% | | | Difference | | -0.13 | | -0.18 | | cpd = Cycles per degree FDA Summary of Safety and Effectiveness Data: P980040/S176 29 of 59 {29} **Mean ($\pm 1$ SD) Monocular Best Corrected Distance Mesopic Contrast Sensitivity (Log Unit) at 6 Months** ![img-2.jpeg](img-2.jpeg) **Mean ($\pm 1$ SD) Binocular Best Corrected Distance Mesopic Contrast Sensitivity (Log Unit) at 6 Months** ![img-3.jpeg](img-3.jpeg) Monocular best corrected distance CS results were stratified by pupil size categories of “small” ($\leq 3.0$ mm), “medium” ($>3.0$ mm to $<4.0$ mm) or “large” ($\geq 4.0$ mm) where pupil size was measured under mesopic conditions. **Figure 6** and **Figure 7** show that the results for monocular mesopic CS without glare and with glare are consistent for all pupil size categories for the TECNIS PureSee™ and control group. There were no clinically meaningful differences ($\leq 0.3$ log units) between lens groups or between pupil size categories. FDA Summary of Safety and Effectiveness Data: P980040/S176 30 of 59 {30} **Mean Monocular Best Corrected Distance Mesopic Contrast Sensitivity Without Glare (Log Unit) By Pupil Size at 6 Months** ![img-4.jpeg](img-4.jpeg) **Mean Monocular Best Corrected Distance Mesopic Contrast Sensitivity With Glare (Log Unit) By Pupil Size at 6 Months** ![img-5.jpeg](img-5.jpeg) ### Ocular/Visual Symptoms The study pre-identified some 'additional endpoints' as supportive clinical information, including ocular/visual symptoms. The study was not designed for statistical comparison of this endpoint. Therefore, only descriptive statistics are presented here. At 6 months, subjects in both lens groups spontaneously reported ocular/visual symptoms in response to the open-ended question, 'Are you having any difficulties with your eyes or vision?'. These subject-reported outcomes for both lens groups are in **Table 22**. The spontaneous reports of halos, night glare, and starbursts ranged from 4.4% (5/113) to 5.3% (6/113) among PureSee™ subjects and 0.9% (1/110) to 4.5% (5/110) among control subjects. When queried in follow-up to the spontaneous report, none of the subjects in the PureSee™ group reported severe halos, night glare, or starbursts. In the control group, one subject reported severe halos and none reported severe night glare or starbursts. FDA Summary of Safety and Effectiveness Data: P980040/S176 31 of 59 {31} **Spontaneous (Non-directed$^{a}$) Reports of Ocular/Visual Symptoms (First Eyes) at 6 Months** | | TECNIS PureSee™ N=113 | | Control N=110 | | | --- | --- | --- | --- | --- | | | n | % | n | % | | Blurred Vision^{b} | | | | | | Overall | 5 | 4.4% | 1 | 0.9% | | Distance | 3 | 2.7% | 0 | 0.0% | | Intermediate | 3 | 2.7% | 7 | 6.4% | | Near | 19 | 16.8% | 22 | 20.0% | | Decreased Vision^{b} | | | | | | Overall | 0 | 0.0% | 0 | 0.0% | | Distance | 0 | 0.0% | 0 | 0.0% | | Intermediate | 0 | 0.0% | 0 | 0.0% | | Near | 1 | 0.9% | 0 | 0.0% | | Halos^{b} | | | | | | Mild | 6 | 5.3% | 5 | 4.5% | | Moderate | 3 | 2.7% | 4 | 3.6% | | Severe | 3 | 2.7% | 0 | 0.0% | | | 0 | 0.0% | 1 | 0.9% | | Night Glare^{b} | | | | | | Mild | 5 | 4.4% | 2 | 1.8% | | Moderate | 0 | 0.0% | 1 | 0.9% | | Severe | 5 | 4.4% | 1 | 0.9% | | | 0 | 0.0% | 0 | 0.0% | | Starbursts^{b} | | | | | | Mild | 6 | 5.3% | 1 | 0.9% | | Moderate | 2 | 1.8% | 1 | 0.9% | | Severe | 4 | 3.5% | 0 | 0.0% | | | 0 | 0.0% | 0 | 0.0% | | Photophobia | 8 | 7.1% | 6 | 5.5% | | Day glare | 2 | 1.8% | 1 | 0.9% | | Night vision difficulty (overall) | 2 | 1.8% | 1 | 0.9% | % = (n/N)*100 Subjects may have reported multiple symptoms. $^{a}$ Responses to the question, “Are you having any difficulties with your eyes or vision?” $^{b}$ Severity collected in follow-up response In addition to spontaneous (non-directed) reports of visual symptoms, the validated Patient Reported Visual Symptoms Questionnaire (PRVSQv2) was included in the study as another “additional endpoint.” The study was not designed for statistical comparison of this endpoint. Therefore, only descriptive statistics are presented here. Subjects were asked about seven specific visual symptoms in the PRVSQv2 that were defined. For example, “occlusions” were defined as “fixed dark or light blocked areas within your vision” and “glare related to scattered light” was defined as “decreases the ability to distinguish differences between objects and their background.” FDA Summary of Safety and Effectiveness Data: P980040/S176 32 of 59 {32} A subject could report multiple symptoms. As shown in Table 23, the most frequently reported questionnaire-directed symptoms at 6 months were sensitivity to light and poor low light vision. In the PureSee™ group, 38 subjects reported experiencing sensitivity to light “sometimes” or more frequently, and 40 subjects reported experiencing poor low light vision “sometimes” or more frequently. In the control group, 37 subjects reported experiencing sensitivity to light “sometimes” or more frequently, and 25 subjects reported experiencing poor low light vision “sometimes” or more frequently. The frequencies of experiencing other symptoms assessed in the PRVSQv2 are below in Table 23. ---FDA Summary of Safety and Effectiveness Data: P980040/S176 33 of 59 {33} **Visual Symptoms at 6 Months** | | | PureSee™ N=113 | | Control N=110 | | | --- | --- | --- | --- | --- | --- | | | | n | % | n | % | | **Halos** | Not Reported | 0 | 0.0% | 0 | 0.0% | | | Never | 83 | 73.5% | 75 | 68.2% | | | Rarely | 8 | 7.1% | 14 | 12.7% | | | Sometimes | 14 | 12.4% | 13 | 11.8% | | | Often | 3 | 2.7% | 5 | 4.5% | | | Always | 5 | 4.4% | 3 | 2.7% | | **Starbursts** | Not Reported | 0 | 0.0% | 0 | 0.0% | | | Never | 80 | 70.8% | 81 | 73.6% | | | Rarely | 7 | 6.2% | 11 | 10.0% | | | Sometimes | 12 | 10.6% | 8 | 7.3% | | | Often | 6 | 5.3% | 7 | 6.4% | | | Always | 8 | 7.1% | 3 | 2.7% | | **Multiple or Double Vision** | Not Reported | 0 | 0.0% | 0 | 0.0% | | | Never | 97 | 85.8% | 103 | 93.6% | | | Rarely | 4 | 3.5% | 1 | 0.9% | | | Sometimes | 10 | 8.8% | 3 | 2.7% | | | Often | 0 | 0.0% | 2 | 1.8% | | | Always | 2 | 1.8% | 1 | 0.9% | | **Sensitivity to Light** | Not Reported | 0 | 0.0% | 0 | 0.0% | | | Never | 62 | 54.9% | 61 | 55.5% | | | Rarely | 13 | 11.5% | 12 | 10.9% | | | Sometimes | 26 | 23.0% | 26 | 23.6% | | | Often | 6 | 5.3% | 8 | 7.3% | | | Always | 6 | 5.3% | 3 | 2.7% | | **Glare Related to Scattered Light** | Not Reported | 0 | 0.0% | 0 | 0.0% | | | Never | 92 | 81.4% | 91 | 82.7% | | | Rarely | 8 | 7.1% | 4 | 3.6% | | | Sometimes | 8 | 7.1% | 10 | 9.1% | | | Often | 3 | 2.7% | 3 | 2.7% | | | Always | 2 | 1.8% | 2 | 1.8% | | **Occlusions** | Not Reported | 0 | 0.0% | 0 | 0.0% | | | Never | 110 | 97.3% | 109 | 99.1% | | | Rarely | 1 | 0.9% | 0 | 0.0% | FDA Summary of Safety and Effectiveness Data: P980040/S176 34 of 59 {34} | | Sometimes | 0 | 0.0% | 0 | 0.0% | | --- | --- | --- | --- | --- | --- | | | Often | 0 | 0.0% | 1 | 0.9% | | | Always | 2 | 1.8% | 0 | 0.0% | | **Poor Low Light Vision** | Not Reported | 0 | 0.0% | 0 | 0.0% | | | Never | 62 | 54.9% | 72 | 65.5% | | | Rarely | 11 | 9.7% | 13 | 11.8% | | | Sometimes | 29 | 25.7% | 17 | 15.5% | | | Often | 7 | 6.2% | 5 | 4.5% | | | Always | 4 | 3.5% | 3 | 2.7% | % = (n/N)*100 NR = Not Reported If subjects reported experiencing a particular symptom, they were then asked to rate how bothered they were by the symptom (Table 24) and if there was anything they had a lot of difficulty with, or did not do, because of the symptom (Table 25). Among subjects reporting sensitivity to light or poor low light vision in the PureSee™ group, 7 reported very or extremely bothered for sensitivity to light and 5 reported very or extremely bothered for poor low light vision. In the control group, 7 reported very or extremely bothered for sensitivity to light and 3 reported very or extremely bothered for poor low light vision. Among subjects reporting halos, glare, or starbursts in the PureSee™ group, 3 reported very or extremely bothered for each symptom at 6 months. In the control group, 3 reported very or extremely bothered for halos and starbursts, and 6 reported very or extremely bothered for glare at 6 months. Among subjects reporting a particular symptom, the number of subjects reporting there was anything they had a lot of difficulty with or did not do because of that symptom at 6 months ranged from 0 to 7 subjects in the PureSee™ group and 1 to 8 subjects in the control group. **Experience/Bother With Visual Symptoms at 6 Months** | | | TECNIS PureSee™ N=113 | | Control N=110 | | | --- | --- | --- | --- | --- | --- | | | | n | % | n | % | | **Halos** | Did not experience or NR | 83 | 73.5% | 75 | 68.2% | | | Not at all bothered | 10 | 8.8% | 14 | 12.7% | | | Slightly bothered | 10 | 8.8% | 13 | 11.8% | | | Moderately bothered | 7 | 6.2% | 5 | 4.5% | | | Very bothered | 3 | 2.7% | 3 | 2.7% | | | Extremely bothered | 0 | 0.0% | 0 | 0.0% | | **Starbursts** | Did not experience or NR | 80 | 70.8% | 81 | 73.6% | | | Not at all bothered | 8 | 7.1% | 9 | 8.2% | | | Slightly bothered | 11 | 9.7% | 12 | 10.9% | | | Moderately bothered | 11 | 9.7% | 5 | 4.5% | | | Very bothered | 2 | 1.8% | 3 | 2.7% | FDA Summary of Safety and Effectiveness Data: P980040/S176 35 of 59 {35} | | Extremely bothered | 1 | 0.9% | 0 | 0.0% | | --- | --- | --- | --- | --- | --- | | **Multiple or Double Vision** | Did not experience or NR | 97 | 85.8% | 103 | 93.6% | | | Not at all bothered | 2 | 1.8% | 0 | 0.0% | | | Slightly bothered | 7 | 6.2% | 3 | 2.7% | | | Moderately bothered | 4 | 3.5% | 2 | 1.8% | | | Very bothered | 3 | 2.7% | 1 | 0.9% | | | Extremely bothered | 0 | 0.0% | 1 | 0.9% | | **Sensitivity to Light** | Did not experience or NR | 62 | 54.9% | 61 | 55.5% | | | Not at all bothered | 5 | 4.4% | 3 | 2.7% | | | Slightly bothered | 28 | 24.8% | 19 | 17.3% | | | Moderately bothered | 11 | 9.7% | 20 | 18.2% | | | Very bothered | 6 | 5.3% | 4 | 3.6% | | | Extremely bothered | 1 | 0.9% | 3 | 2.7% | | **Glare Related to Scattered Light** | Did not experience or NR | 92 | 81.4% | 91 | 82.7% | | | Not at all bothered | 2 | 1.8% | 2 | 1.8% | | | Slightly bothered | 12 | 10.6% | 10 | 9.1% | | | Moderately bothered | 4 | 3.5% | 1 | 0.9% | | | Very bothered | 3 | 2.7% | 6 | 5.5% | | | Extremely bothered | 0 | 0.0% | 0 | 0.0% | | **Occlusions** | Did not experience or NR | 110 | 97.3% | 109 | 99.1% | | | Not at all bothered | 1 | 0.9% | 1 | 0.0% | | | Slightly bothered | 1 | 0.9% | 0 | 0.0% | | | Moderately bothered | 1 | 0.9% | 0 | 0.0% | | | Very bothered | 0 | 0.0% | 1 | 0.9% | | | Extremely bothered | 0 | 0.0% | 0 | 0.0% | | **Poor Low Light Vision** | Did not experience or NR | 62 | 54.9% | 72 | 65.5% | | | Not at all bothered | 7 | 6.2% | 8 | 7.3% | | | Slightly bothered | 31 | 27.4% | 16 | 14.5% | | | Moderately bothered | 8 | 7.1% | 11 | 10.0% | | | Very bothered | 4 | 3.5% | 3 | 2.7% | | | Extremely bothered | 1 | 0.9% | 0 | 0.0% | % = (n/N)*100 NR = Not Reported FDA Summary of Safety and Effectiveness Data: P980040/S176 36 of 59 {36} **Difficulty With Activity Due to Visual Symptoms at 6 Months** | (Directed Questionnaire) | TECNIS PureSee™ N=113 | | Control N=110 | | | | --- | --- | --- | --- | --- | --- | | | | n | % | n | % | | **Halos** | Did not experience or NR | 83 | 73.5% | 75 | 68.2% | | | No | 26 | 23.0% | 34 | 30.9% | | | Yes | 4 | 3.5% | 1 | 0.9% | | **Starbursts** | Did not experience or NR | 80 | 70.8% | 81 | 73.6% | | | No | 28 | 24.8% | 27 | 24.5% | | | Yes | 5 | 4.4% | 2 | 1.8% | | **Multiple or Double Vision** | Did not experience or NR | 97 | 85.8% | 103 | 93.6% | | | No | 12 | 10.6% | 5 | 4.5% | | | Yes | 4 | 3.5% | 2 | 1.8% | | **Sensitivity to Light** | Did not experience or NR | 62 | 54.9% | 61 | 55.5% | | | No | 46 | 40.7% | 42 | 38.2% | | | Yes | 5 | 4.4% | 7 | 6.4% | | **Glare Related to Scattered Light** | Did not experience or NR | 92 | 81.4% | 91 | 82.7% | | | No | 16 | 14.2% | 15 | 13.6% | | | Yes | 5 | 4.4% | 4 | 3.6% | | **Occlusions** | Did not experience or NR | 110 | 97.3% | 109 | 99.1% | | | No | 3 | 2.7% | 0 | 0.0% | | | Yes | 0 | 0.0% | 1 | 0.9% | | **Poor Low Light Vision** | Did not experience or NR | 62 | 54.9% | 72 | 65.5% | | | No | 44 | 38.9% | 30 | 27.3% | | | Yes | 7 | 6.2% | 8 | 7.3% | % = (n/N)*100 NR = Not Reported ## Lens Findings Lens findings was another pre-identified “additional endpoint” for supportive clinical information. The study was not designed for statistical comparison of this endpoint. Therefore, only descriptive statistics are presented here. There were no reports of any lens findings (e.g. lens instability, glistenings) at 6 months for TECNIS PureSee™ or control IOLs. ## Fundus Visualization The investigator’s assessment of his/her ability to clinically visualize the fundus at 6 months (seventh co-primary safety endpoint), was adequate for all first eyes (100.0%) and all-eyes (100.0%) in the study. FDA Summary of Safety and Effectiveness Data: P980040/S176 37 of 59 {37} ## 2. Effectiveness Results The analysis of effectiveness was based on the 223 evaluable subjects at the 6-month time point. The Intent-To-Treat (ITT) population was the primary analysis set for all primary effectiveness endpoints. In addition, the Per-Protocol (PP) population first eyes was a primary analysis set for the BCDVA primary effectiveness endpoint. All other effectiveness results are shown for the Safety Population (SP) with observed case (i.e., available data with no imputation) unless specified otherwise. First eyes were primary eyes and presented in the monocular data tables, unless specified otherwise. All success criteria for all primary effectiveness endpoints were met for the TECNIS PureSee™ lens. Key effectiveness outcomes are presented in Tables 26 to 50 and Figur…
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