FINEVISION HP Trifocal IOLs

P240038 · Beaver Visitec International, Inc. · HQL · Sep 10, 2025 · Ophthalmic

Device Facts

• Record ID: P240038
• Device Name: FINEVISION HP Trifocal IOLs
• Applicant: Beaver Visitec International, Inc.
• Product Code: HQL · Ophthalmic
• Decision Date: Sep 10, 2025
• Decision: APPR
• Regulation: 21 CFR 886.3600
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

The FINEVISION HP Trifocal IOL is indicated for primary implantation in the capsular bag in the posterior chamber of the eye 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 by phacoemulsification. The lens mitigates the effects of presbyopia by providing improved intermediate and near visual acuity, while maintaining comparable distance visual acuity compared to a monofocal IOL.

Device Story

Single-piece, foldable, multifocal intraocular lens (IOL) for posterior chamber implantation; replaces human crystalline lens after cataract removal. Features biconvex, aspheric, apodized diffractive optic; provides distance, intermediate (+1.75 D), and near (+3.50 D) vision. Optic material is UV-absorbing and blue-light-filtering hydrophobic acrylic. Delivered via injector into capsular bag. Used by ophthalmologists in surgical settings. Output is refractive correction; improves patient visual range and reduces spectacle dependence. Benefits include improved intermediate/near acuity compared to monofocal IOLs.

Clinical Evidence

Prospective, multicenter, randomized, double-masked pivotal study (IDE G210165) of 512 randomized subjects (341 test, 171 control). Primary endpoints: non-inferiority of BCDVA (4m) and superiority of DCNVA (40cm) and DCIVA (66cm) at 6 months. Results: FINEVISION HP met non-inferiority for BCDVA and superiority for DCNVA and DCIVA (p<0.0001). Safety profile comparable to monofocal control; low rate of secondary surgical interventions (<1%).

Technological Characteristics

Single-piece, aspheric biconvex apodized non-toric diffractive IOL. Material: UV-absorbing/blue-light-filtering acrylate/methacrylate copolymer. Refractive index: 1.53. Optic diameter: 6.0mm; overall: 11.4mm. Haptic: Double C-loop (POD) quadripode. Sterilization: Moist steam. Complies with ISO 11979-2, 11979-3, 11979-5.

Indications for Use

Indicated for adult patients (age 22+) with cataracts and <1D pre-existing corneal astigmatism undergoing phacoemulsification. Mitigates presbyopia by improving intermediate and near visual acuity while maintaining distance acuity.

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.

Reference Devices

• AcrySof Monofocal IOL Model SN60AT

Submission Summary (Full Text)

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SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED)

# I. GENERAL INFORMATION

Device Generic Name: Intraocular Lens

Device Trade Name: FINEVISION HP Trifocal IOL

Device Procode: Intraocular Lens (HQL)
Multifocal Intraocular (MFK)

Applicant's Name and Address: Beaver-Visitec International, Inc.
500 Totten Pond Rd, 10 CityPoint,
Waltham, MA 02451

Date(s) of Panel Recommendation: None

Premarket Approval Application (PMA) Number: P240038

Date of FDA Notice of Approval: 9/10/2025

# II. INDICATIONS FOR USE

The FINEVISION HP Trifocal IOL is indicated for primary implantation in the capsular bag in the posterior chamber of the eye 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 by phacoemulsification. The lens mitigates the effects of presbyopia by providing improved intermediate and near visual acuity, while maintaining comparable distance visual acuity compared to a monofocal IOL.

# III. CONTRAINDICATIONS

There are no known contraindications.

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# IV. WARNINGS AND PRECAUTIONS

The warnings and precautions can be found in the FINEVISION HP Trifocal IOL labeling.

# V. DEVICE DESCRIPTION

The FINEVISION HP Trifocal IOL is an ultraviolet absorbing and blue light filtering foldable multifocal IOL. Each IOL is a single-piece design with a central optic and 4 open-loop haptics (Double C-loop) (Figure 1). The optic consists of a proprietary high refractive index hydrophobic acrylic material with a UV absorbing filter ( $&lt; 24\%$ transmittance at $400\mathrm{nm}$ for a $+20.0$ D IOL) and a blue light filtering chromophore ( $&lt; 64\%$ at $450\mathrm{nm}$ for a $+20.0$ D IOL). The optic is biconvex and consists of a 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 $6.0\mathrm{mm}$ in diameter and the lens has an overall diameter of $11.4\mathrm{mm}$ . After surgical insertion into the eye, the lens unfolds to its intended shape. The optic diffractive structure is apodized on the entire front portion of the optic and divides the incoming light to create a $+1.75$ D intermediate and a $+3.50$ D near add power at the IOL plane. The anterior surface is designed with negative spherical aberration to partially compensate for the positive spherical aberration of the cornea. The physical properties of this lens are described in Table 1 and Figures 1, 2, and 3.

Table 1: Physical Characteristics of FINEVISION HP Trifocal IOLs

| Physical Characteristic | Description |
| --- | --- |
| Optic Type | Single-piece IOL with aspheric biconvex apodized non-toric diffractive optic |
| UV cutoff at 24% T | 400 nm for +20.0 D |
| Index Of Refraction | 1.53 |
| Spherical power | +6 D to +35 D (0.5D steps) |
| Add powers | +1.75D intermediate and +3.50D near add power at the IOL plane (representing +1.20 D and +2.40 D at the corneal plane after implantation, respectively, for the average human eye) |
| Haptic configuration | Double C-loop (POD) quadripode |
| Lens Material | Ultraviolet light absorbing and blue light filtering Acrylate/Methacrylate Copolymer |
| Optic diameter | 6.00mm |
| Overall diameter | 11.40mm |
| Haptic angle | 5° |
| Sterilization | Moist steam |

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(A) Front view

Figure 1: Physical Characteristics of FINEVISION HP Trifocal IOL. (A) Front view. (B) Side view.
(B) Side view

Figure 2: Spectral Transmittance of FINEVISION HP Trifocal IOL for the entire marketed power range as well as data from human crystalline lenses of ages 4 to 53 years.
Hammond, B. R., Jr., Renzi, L. M., Sachak, S., &amp; Brint, S. F. (2010). Contralateral comparison of blue-filtering and non-blue-filtering intraocular lenses: glare disability, heterochromatic contrast, and photostress recovery. *Clinical Ophthalmology*, 4, 1465–1473.

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Figure 3: Graph of theoretical light energy repartition between the 3 foci between 2.0- and 4.5-mm pupillary aperture by increments of $0.5\mathrm{mm}$ at $546~\mathrm{nm}$ .

# Mode of Action

The FINEVISION HP Trifocal IOLs are intended to be positioned in the lens capsule in the posterior chamber of the eye, replacing the human crystalline lens. This position allows the lens to function as a refractive medium in the correction of aphakia. This IOL has a biconvex optic containing an aspheric design and a diffractive structure on the anterior surface. The diffractive structure divides incoming light to provide a range of vision from distance to intermediate to near. This IOL provides an option for clinicians to provide patients an intermediate add power of $+1.75$ D and a near add power of $+3.50$ D (in the IOL plane).

# VI. ALTERNATIVE PRACTICES AND PROCEDURES

There are several other alternatives for the correction of cataracts. These 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.

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VII. MARKETING HISTORY

The FINEVISION HP Trifocal IOLs are currently commercially available in the European Union, Albania, Australia, New Zealand, Azerbaijan, Bahrain, Bangladesh, Bolivia, Brazil, Chile, Colombia, Costa Rica, Ecuador, Egypt, Hong Kong, India, Iran, Iraq, Israel, Ivory Coast, Japan, Jordan, South Korea, Kuwait, Lebanon, Libya, Malaysia, Morocco, Oman, Peru, Philippines, Saudi Arabia, Singapore, South Africa, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, Ukraine, United Kingdom, and Vietnam. The lenses have not been withdrawn from any country for any reason including 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.

- Ocular infection (endophthalmitis, microbial keratitis)
- Inflammatory reaction (e.g. uveitis, Toxic anterior segment syndrome (TASS), hypopyon)
- Anterior capsule contraction syndrome (ACCS) (Phimosis)
- Corneal edema
- Corneal endothelial damage
- Cystoid macular edema (CME)
- Secondary surgical intervention (include, but are not limited to: lens repositioning, lens replacement, vitreous aspiration, iridectomy for pupillary block, wound leak repair, and retinal detachment repair)
- IOL dislocation, tilt, decentration, luxation, rotation
- Elevated intraocular pressure
- Pupillary block
- Posterior capsular opacification (PCO)
- Chromatic aberrations
- Dysphotopsia
- Loss of visual acuity
- Deviation from target refraction
- Hyphema
- Retinal detachment
- Iris or pupil damage
- Posterior capsular rupture
- Vitreous loss
- Wound leak (positive Seidel)

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Additional complications that may occur following implantation of a multifocal intraocular lens include objectionable visual quality under certain lighting conditions (e.g., chromatic aberrations, halos, night glare, decreased contrast), hazy/filmy images, "ghost" imaging of near and/or distant objects, diplopia and poor stereopsis. Some of these optical effects may be mitigated upon patient's adaptation to the multifocal optic. However, some of the above listed complications may require secondary surgical intervention for intraocular lens exchange or explantation.

For the specific adverse events that occurred in the clinical study, please see Section X below.

## IX. SUMMARY OF NON-CLINICAL STUDIES

### Biocompatibility Testing

The studies listed in Table 2 below were conducted to meet ISO 11979-5:2006 and ISO 10993 requirements and were as well as the United States Food and Drug Administration. Use of International Standards ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process". All tests to evaluate the biocompatibility were conducted in accordance with provisions of 21 CFR 58, Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies.

Table 2: Biocompatibility Testing

| Test | Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| Cytotoxicity Testing – Agar Overlay | Evaluate the potential for cellular toxicity | Non-cytotoxic | Pass |
| Cytotoxicity – Agar Diffusion | Evaluate the potential for cellular toxicity | Non-cytotoxic | Pass |
| Cytotoxicity – MEM Elution Assay | Evaluate the potential for cellular toxicity | Non-cytotoxic | Pass |
| Genotoxicity – Bacterial Reverse Mutation | Evaluate the potential for mutagenic activity | Non-mutagenic | Pass |
| Genotoxicity – In vitro Micronucleus Test | Evaluate the potential for genotoxic activity | Non-genotoxic | Pass |
| Sensitization | Evaluate the potential for sensitization | Non-sensitizer | Pass |
| Primary Ocular Irritation | Determine if extracts of IOL caused irritation in the eyes of rabbits | Non-irritant to the ocular tissues of the model animal. | Pass |
| Intracutaneous Injection | See the potential to produce irritation after injection | Test article meets the requirements of ISO 10993-10 | Pass |
| Systemic Toxicity | Evaluate biological reaction to extracts | Test article meets the requirements of ISO 10993-11 | Pass |
| Material Mediated Pyrogenicity | Potential to produce a pyrogenic response | Test article is considered non-pyrogenic and meets the requirements of ISO 10993-11 | Pass |
| Intramuscular Implantation | Evaluate muscle reaction after implantation | Test article meets the requirements of ISO 10993-6 | Pass |

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| Test | Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| Complement Activation | potential for activation of the complement system. | Test article meets the requirements of ISO 10993-4 | Pass |
| Hemolysis (Extract Method) | Potential to cause hemolysis in human blood | Test article meets the requirements of ISO 10993-4 | Pass |
| Hemolysis (Direct Contact Method) | Potential to cause hemolysis in human blood | Test article meets the requirements of ISO 10993-4 | Pass |
| Biocompatibility and Capsular Bag Opacification | Assessment of capsular bag opacification | Test article meets the requirements of ISO 11979-5:2006 | Pass |

# Physiochemical Tests

The material used for FINEVISION HP Trifocal IOL has been tested to meet the recommendations in ISO 11979-5 Ophthalmic implants- intraocular Lenses Part 5-Biocompatibility and has Pass the tests listed in Table 3 below.

Table 3: Chemical Testing

| Test | Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| Exhaustive Extraction | Soxhlet extraction to recover polymerization residuals, impurities, and additives, quantitative analysis of extracts | ISO 11979-5:2020 Section 5.3 and Annex A | Pass |
| Hydrolytic Stability | Test to verify material does not degrade by hydrolysis | ISO 11979-5:2020 Section 5.5 and Annex C | Pass |
| Leachable Extraction | Extraction procedure to simulate leachable components that are expected to be released in-vivo | ISO 11979-5:2020 Section 5.4 and Annex B | Pass |
| Photostability | Test to evaluate photostability over 20 years at 300-400 nm | ISO 11979-5:2020 Section 5.6 and Annex D | Pass |
| Nd-YAG Laser Exposure | Test to evaluate material stability when exposed to Nd-YAG laser treatment, and no leakage of toxic components | ISO 11979-5:2020 Section 5.7 and Annex E | Pass |
| Insoluble Inorganics | Test to verify removal of residual inorganics residues from the manufacturing process. | ISO 11979-5:2020 Section 5.8 | Pass |

# Optical/Mechanical Testing

The mechanical and optical properties of the FINEVISION HP Trifocal IOLs (POD F GF IOLs) were assessed in compliance with ISO 11979-2 Ophthalmic Implants - Intraocular Lenses - Part 2: Optical Properties and Test Methods and ISO 11979-3 Ophthalmic Implants - Intraocular Lenses - Part 3: Mechanical Properties and Test Methods

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Table 4a lists all the tests performed.
Table 4a: Mechanical and Optical Testing

| Test | Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| Dimensions | To assess conformance to dimensional tolerances | ISO 11979-3:2012 Section 4.2 | Pass |
| Surface and Bulk Homogeneity | To ensure IOL is free of surface and bulk defects | ISO 11979-3:2012 Section 4.12 | Pass |
| Mechanical Characterization (Compression Force, Force Decay, Angle of Contact, Axial Displacement) | To characterize the mechanical properties of the IOL | ISO 11979-3:2012 Sections 4.4, 4.5, 4.8, 4.9 | Pass |
| Optic Decentration | To assess optic decentration under compression | ISO 11979-3:2012 Section 4.6 | Pass |
| Optic Tilt | To assess optic tilt under compression | ISO 11979-3:2012 Section 4.7 | Pass |
| Dynamic Fatigue | To assess the ability of the haptics to withstand cyclic compressive loading | ISO 11979-3:2012 Section 4.10 | Pass |
| Surgical Manipulation (Haptic Pull Test) | To assess the force required to separate the haptic from the optic | ISO 11979-3:2012 Section 4.11 | Pass |
| Dioptric Power and Image Quality | To assess conformance to optical power and image quality tolerances | ISO 11979-2:2014 Sections 4.2.1, 4.2.3, 4.3 | Pass |
| Image Quality with Tilt and Decentration | To assess image quality under off-axis conditions | ISO 11979-2:2014 Section 4.3 | Pass |
| Spectral Transmittance | To characterize the spectral transmittance of the IOL | ISO 11979-2:2014 Section 4.4.2 | Pass |
| Glistening Testing | To characterize glistening performance of the IOL | Average Grade 0 according to Miyata Scale | Pass |

The optical properties of the FINEVISION HP Trifocal IOL are also illustrated in the Modulation Transfer (MTF) through focus response at $50~\mathrm{lp / mm}$ for a 2.0, 3.0-, and $4.5\mathrm{-mm}$ aperture, as shown in Figure 4.

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Figure 4: Illustrative FINEVISION HP Trifocal IOL MTF through focus response at 50 lp/mm for a 2.0, 3.0-, and 4.5-mm aperture, in green light with ISO1 cornea.

# Simulated Surgical Manipulation Testing

Recovery of mechanical and optical properties of the FINEVISION HP Trifocal IOLs (POD F GF IOLs) after simulated surgical manipulation was assessed in compliance with ISO 11979-3: 2012 and ISO 11979-2: 2014. The objective was to document that the FINEVISION HP Trifocal IOLs can be successfully delivered using Medicel Accuject 2.1 inserter. Testing was performed with the INJ100 inserter and NuVisc Pro viscoelastic (OVD).

Table 4b lists all the tests performed.
Table 4b: Recovery of mechanical and optical properties testing

| Test | Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| IOL Dimensions (Pre- and Post-Delivery) | To assess conformance to dimensional tolerances | ISO 11979-3:2012 Section 5 > ISO 11979-3:2012 Section 4.2 | Pass |
| Surface and Bulk Homogeneity (Pre- and Post-Delivery) | To ensure IOL is free of surface and bulk defects | ISO 11979-3:2012 Section 5 > ISO 11979-3:2012 Section 4.12 | Pass |
| Dioptric Power and Image Quality (Post-Delivery) | To assess conformance to optical power and image quality tolerances | ISO 11979-3:2012 Section 5 > ISO 11979-2:2014 | Pass |

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| Delivery Outcome | To assess the ability of the insertion device to deliver the IOL | IOL cannot flip over upon delivery, IOL must exit inserter upon completion of delivery (no IOL stuck). | Pass |
| --- | --- | --- | --- |

# Sterilization and Stability Evaluation

Sterilization evaluation, shelf-life and transport stability testing, and bacterial endotoxin testing were performed to support the FINEVISION HP Trifocal IOL. The results are summarized in Table 5.

Table 5: Sterilization Evaluation Results

| Test | Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| Moist heat sterilization validation (Overkill method) (ISO 17665-1, ISO 17665-2 & ISO 17665-3) | Determination of process parameters for routine sterilization of product, and demonstration that these process parameters can adequately achieve a Sterility Assurance Level (SAL) of 10-6, based upon inactivation of control biological indicators (BIs, G. stearothermophilus) in process challenge devices (PCDs). | Successful performance of Installation Qualification (IQ), Operational Qualification (OQ) and both Microbiological and Physical Performance Qualification (PQ) studies. The Microbiological PQ study requires total inactivation of BIs upon exposure to a half-cycle (e.g., half of the routine full-cycle exposure time) that meets the designated parameters. The Physical PQ study requires that routine full-cycle parameters can be achieved with minimum and maximum sterilization loads. Together these PQ results will demonstrate the routine sterilization process can achieve an SAL ≤ 10-6. | Pass |

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| Test | Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| Transport stability (ISO 11979-6, ISO 11607-1, ASTM F88, ASTM F1929, & ASTM D3078) | Confirm that the sterile barrier packaging can maintain device sterility throughout anticipated transport conditions. Testing includes visual inspection, whole package integrity (bubble emission testing), and seal integrity assessments (seal peel and dye penetration testing) after transport conditioning. | Meets lens cosmetics and functional delivery requirements. Meets sterile barrier packaging visual inspection, whole package integrity & seal integrity requirements. For visual inspection, no channels, voids, punctures, or breaches observed, and labels are legible. For whole package integrity assessed by bubble emission testing of the primary vial sterile barrier, no leaks are observed. For seal integrity, assessed by seal peel and dye penetration testing of the secondary blister tray packaging, average peel strength and no penetration of dye into seal area are observed, respectively. | Pass |
| Shelf-life stability (ISO 11979-6 & ISO 11607-1) | Confirm that device performance is maintained throughout claimed shelf-life. | Meets optical, mechanical, chemical and biological testing requirements | Pass |
| Package Integrity (ISO 11979-6, ISO 11607-1, ASTM F88, ASTM F1929, & ASTM D3078) | Confirm that the primary sterile barrier packaging can maintain device sterility throughout claimed shelf life. Testing includes visual inspection, whole package integrity (bubble emission testing), and seal integrity assessments (seal peel and dye penetration testing) after aging (both accelerated aging and real-time aging conditions). | Meets sterile barrier packaging visual inspection, whole package integrity & seal integrity requirements. For visual inspection, no channels, voids, punctures, or breaches observed, and labels are legible. For whole package integrity assessed by bubble emission testing of the primary vial sterile barrier, no leaks are observed. For seal integrity, assessed by seal peel and dye penetration testing of the secondary blister tray packaging, average peel strength and no penetration of dye into seal area are observed, respectively. | Pass |
| Bacterial Endotoxin Testing (ANSI/AAMI ST72, USP<85>, FDA Guidance on Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices) | Confirm that Endotoxin present on product is below the permanent intraocular device limit to confirm product is non-pyrogenic. | ≤ 0.2 Endotoxin Units (EU)/device | Pass |
| Bioburden Estimation Testing (ISO 11737-1) | Confirm that naturally occurring Bioburden is controlled on product and in manufacturing environment. | Less than the Action Limit of < 50 Colony Forming Units (CFU)/device | Pass |

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PMA (P240038): FDA Summary of Safety and Effectiveness Data

# X. SUMMARY OF PRIMARY CLINICAL STUDY

The applicant performed a clinical study to establish a reasonable assurance of safety and effectiveness of implantation with the FINEVISION HP Trifocal IOLs for the visual correction of aphakia in adult subjects with less than 1 D of pre-existing corneal astigmatism, following removal of a cataractous lens to mitigate the effects of presbyopia by providing improved intermediate and near visual acuity, while maintaining comparable distance visual acuity to a monofocal IOL, in the US under IDE G210165. Data from this clinical study was the basis for the PMA approval decision. A summary of the clinical study is presented below.

## A. Study Design

Subjects were treated between April 2022 and April 2023. The database for this PMA reflected data collected through 15 Aug 2024 and included 539 subjects. There were 20 US investigational sites.

The study was a prospective, multicenter, randomized, active controlled, double masked pivotal study. This study was designed to evaluate the effectiveness and safety of FINEVISION HP Trifocal IOL in providing a range of vision (distance, intermediate, and near) as compared to a standard monofocal IOL, the AcrySof Monofocal IOL Model SN60AT. Adult subjects with operable cataracts in both eyes who were eligible for phacoemulsification cataract surgery followed by IOL implantation were randomized at a 2:1 ratio to receive either the FINEVISION HP Trifocal IOL (test) or the AcrySof SN60AT Monofocal IOL (control) in both eyes. Subjects underwent cataract surgery/IOL implantation in the second eye 7 to 30 days after the first eye surgery. Subjects attended 5 post-operative evaluation visits for each eye where they underwent ophthalmic examinations over a period of approximately 12 months.

The control IOL is a legally marketed monofocal lens.

A total of 501 subjects were planned for bilateral implantation in a 2:1 ratio, in order to ensure that at least 300 eligible subjects in the test arm and 150 subjects in the control arm completed the study. This sample size assumed a dropout rate of 10% and was based on the following assumptions (Table 6). Subjects were randomly assigned to receive either the investigational FINEVISION HP Trifocal IOL or the AcrySof monofocal IOL in both eyes according to the randomization schedule (2:1 ratio) provided following the completion of informed consent and screening procedures. Randomization was stratified by site. The randomization schedule was created using computer-generated randomization methodology by an independent statistician who was not involved in the day-to-day conduct of the study.

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Table 6: Sample Size Calculations

| | Margin | Expected Difference | SD | Type I error sided | Power |
| --- | --- | --- | --- | --- | --- |
| Non-Inferiority | | | | | |
| BCDVA (4 m) | 0.1 | 0.0 | 0.10 | 5% | >99% |
| Superiority | | | | | |
| DCNVA (40 cm) | | -0.10 | 0.14 | 2.5% | >99% |
| DCIVA (66 cm) | | -0.10 | 0.14 | 2.5% | >99% |

Abbreviations: BCDVA = best Corrected Distance Visual Acuity; DCNVA = Distance-Corrected near Acuity; DCIVA = Distance-Corrected Intermediate Visual Acuity; SD = Standard Deviation

# 1. Clinical Inclusion and Exclusion Criteria

Enrollment in the FINEVISION HP Trifocal IOL study was limited to subjects who met the following inclusion criteria in both eyes:

1) Male or female adults, age 22 years or older at the Preoperative Visit.
2) Visually significant cataracts in both eyes that are eligible for phacoemulsification cataract surgery.
3) Willing to undergo cataract surgery in the second operative eye within 7 - 30 days after surgery in the first eye.
4) Projected BCDVA of 0.2 logMAR (20/32 Snellen) or better in each eye after cataract surgery/IOL implantation, as determined by the medical judgement of the Investigator
5) Eligible for receipt of an IOL power within the range of the investigational IOL (+10.0 D to +30.0 D, in 0.50 D increments) in each eye
6) Contact lens users must be willing to discontinue wear of their lenses in accordance with the following requirements:

- Rigid gas permeable lenses for $\geq 7$ days prior to the Preoperative Visit
- Soft contact lenses for $\geq 3$ days prior to the Preoperative Visit

Contact lens wearers must demonstrate a stable refraction (within $\pm 0.50$ D for both sphere and cylinder) in each eye, as determined by manifest refraction on two consecutive examination dates at least one week apart after discontinuation of contact lens wear.

7) Provide signed written consent prior to participation in any study-related procedures.
8) Ability, comprehension, and willingness to follow study instructions, and likely to complete all study visits.
9) Female subjects must be 1-year postmenopausal, surgically sterilized, or, if of childbearing potential, have a negative urine pregnancy test at the Preoperative Visit. Women of childbearing potential must use an acceptable form of contraception throughout

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the study. Acceptable methods include at least one of the following: intrauterine (intrauterine device), hormonal (oral, injection, patch, implant, ring), barrier with spermicide (condom, diaphragm), or abstinence.

Subjects were not permitted to enroll in the FINEVISION HP Trifocal IOL study if they met any of the following exclusion criteria:

1) History or presence of, or predisposition to, degenerative visual disorders (e.g., macular degeneration, retinal detachment, proliferative diabetic retinopathy, or other retinal disorders) predicted to result in BCDVA worse than 0.2 LogMAR (20/32 Snellen) in either eye during the study participation period.
2) Significant anterior segment pathology in either eye that might increase intraoperative risk or compromise IOL stability (e.g., pseudoexfoliation syndrome)
3) Reasonably expected to require secondary ocular surgical intervention or laser treatment other than YAG capsulotomy in either eye during the study participation period.
4) Presence of one or more clinically significant corneal abnormalities in either eye, including corneal dystrophy, irregularity, or edema per the Investigator's medical opinion.
5) Previous intraocular, corneal, or retinal detachment surgery, including corneal transplant, LASIK, astigmatic keratotomy and limbal relaxing incisions in either eye
6) Rubella, congenital, traumatic or complicated cataract in either eye
7) Preoperative keratometric astigmatism &gt; 1.0 D or irregular corneal astigmatism in either eye (Note: corneal incisions intended to reduce astigmatism are not permitted)
8) Clinically significant ocular inflammation or infection present ≤ 30 days in either eye prior to the Preoperative Visit.
9) Presence or history of one or more severe/serious ocular conditions (e.g., glaucoma, uveitis, ocular infection, severe dry eye) in either eye, or any other unstable medical condition (e.g., uncontrolled diabetes) that in the opinion of the Investigator would put the subject's health at risk, confound the results of the study and/or prevent the subject from completing all study visits.
10) Use of medications known to interfere with visual performance, pupil dilation, or iris structure ≤ 30 days prior to the Preoperative Visit.
11) Participation in any study of an investigational, interventional product within 30 days prior to the Preoperative Visit or at any time during the study period.
12) Pregnant or nursing females.

The following were intraoperative criteria for not implanting the device:

1) Intraoperative complications during the phacoemulsification and IOL implant that require any other additional procedures or further intervention
2) Significant detachment of Descemet's membrane

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3) Significant corneal endothelial damage
4) Wound burn
5) Capsular tear, iris incarceration or damage, posterior capsular rupture, vitreous loss or prolapse, or zonular weakness, dehiscence or rupture
6) Significant anterior chamber bleeding
7) Excessive iris mobility or need for iris manipulation
8) Mechanical or surgical manipulation required to enlarge the pupil prior to or at IOL implantation
9) Other ocular conditions or complications that could compromise IOL stability
10) Bag sulcus, sulcus-sulcus or unknown placement of haptics
11) Any method of anterior capsulotomy other than circular continuous capsulorhexis (e.g., anterior capsular tears or any areas of 'can-opener' capsulotomy or FLACS)
12) Capsular fibrosis or other opacity
13) Optic and/or haptic damage/amputation
14) Inability to fixate IOL in desired position

# 2. Follow-up schedule

All subjects were scheduled to return for follow-up examinations postoperatively as mentioned in Table 7.

Table 7: Study Design

| Scheduled Visit | Eyes Evaluated | Visit Window |
| --- | --- | --- |
| Pre-Operative Visit 0 | Both Eyes | Day -90 to -1 |
| Operative Visit 00A | 1stOperative Eye | Day 0 |
| Post-Operative Visit 1A | 1stOperative Eye | Day 1 to 2 post Operative Visit 00A |
| Post-Operative Visit 2A | 1stOperative Eye | Day 7 to 14 post Operative Visit 00A |
| Post-Operative Visit 3A | 1stOperative Eye | Day 30 to 60 post Operative Visit 00A |
| Operative Visit 00B | 2ndOperative Eye | Day 7 to 30 post Operative Visit 00A |
| Post-Operative Visit 1B | 2ndOperative Eye | Day 1 to 2 post Operative Visit 00B |
| Post-Operative Visit 2B | 2ndOperative Eye | Day 7 to 14 post Operative Visit 00B |
| Post-Operative Visit 3B | 2ndOperative Eye | Day 30 to 60 post Operative Visit 00B |
| Post-Operative Visit 4 | Both Eyes | Day 150 to 180 post Operative Visit 00A |
| Post-Operative Visit 5 | Both Eyes | Day 360 to 420 post Operative Visit 00A |

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Note: IOL implantation in the second eye was intended to occur between 7 and 30 days after IOL implantation in the first eye.

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Preoperatively, several examinations and clinical assessments were performed, as listed in Table 8. Postoperatively, objective parameters were measured during the study and are listed below, in Table 8. Specific examinations and scheduled clinical assessments are presented in Table 8. Adverse events and complications were recorded at all visits.

The key timepoints are shown below in the tables summarizing safety and effectiveness.

Table 8: Schedule of Assessments

| | | | Visit 0 | Visit 00 A | Visit 00 B | Visit 1 A/B | Visit 2 A/B | Visit 3 A/B | Visit 4 | Visit 5 | \( USV^2 \) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Examination | Light Condition | Monocular / Binocular | Pre-Op / Screen D -90 to -1 | Implant A1 D 0 | Implant B1 (D 7 to D 30 after Visit 00 A) | Post-Op D 1-2 | Post-Op D 7-14 | Post-Op D 30-60 | Post-Op D 150-180 (from 1st eye) | Post-Op D 360-420 (from 1st eye) | N/A |
| Informed Consent and HIPAA | | | X | | | | | | | | |
| Demographics | | | X | | | | | | | | |
| Inclusion & Exclusion Criteria Evaluation | | | X | | | | | | | | |
| Inclusion & Exclusion Criteria Review | | | | X | | | | | | | |
| Ocular and non-ocular Medical History | | | X | X | X | X | X | X | X | X | X |
| Urine Pregnancy Test (if applicable) | | | X | | | | | | | | |
| Projected Visual Acuity | | | X | | | | | | | | |
| Target Refraction | | | X | | | | | | | | |
| IOL Power Calculation | | | X | | | | | | | | |
| Axial Length and Anterior Chamber Depth | | | X | | | | | | | | |
| Keratometry Measurement | | | X | | | | | X | X | X | X |
| Corneal Topography | | | X | | | | | | | | |
| Manifest Refraction (ETDRS) – 4 meters | | | X | | | | X | X | X | X | X |
| Randomization | | | X | | | | | | | | |
| Operative Procedures | | | | X | X | | | | | | |
| Patient Reported Outcome Questionnaires3 | | | X | | | | | | X | X | X |

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| | | | | Visit 0 | Visit 00 A | Visit 00 B | Visit 1 A/B | Visit 2 A/B | Visit 3 A/B | Visit 4 | Visit 5 | \( USV^2 \) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Examination | | Light Condition | Monocular / Binocular | Pre-Op / Screen D -90 to -1 | Implant A1 D 0 | Implant B1 (D 7 to D 30 after Visit 00 A) | Post-Op D 1-2 | Post-Op D 7-14 | Post-Op D 30-60 | Post-Op D 150-180 (from 1st eye) | Post-Op D 360-420 (from 1st eye) | N/A |
| Pupil Size4 | Photopic | Monocular | X | | | | | | X | X | | |
| | | | Mesopic | X | | | | | | X | X | |
| Intraocular Pressure | | | | X | | | X | X | X | X | X | X |
| Slit Lamp Examination | | | | X | | | X | X | X | X | X | X |
| IOL Tilt and Decentration Grading | | | | | | | X | X | X | X | X | X |
| IOL Axis Orientation (selected sites only)5 | | | | | X | X | X | X | X | X | X | X |
| Dilated Fundus Examination | | | | X | | | | | X | X | X | X |
| Posterior Capsule Assessment (PCO grade assessment) | | | | | | | X | X | X | X | X | X |
| IOL Observations | | | | | | | X | X | X | X | X | X |
| Adverse Events | | | | X | X | X | X | X | X | X | X | X |
| Device Deficiencies | | | | | X | X | X | X | X | X | X | X |
| Concomitant Medications | | | | X | X | X | X | X | X | X | X | X |
| Exit from Study | | | | | | | | | | | X | |
| Visual Acuity | UCDVA (4 meters) | Photopic | Monocular | X | | | X | X | X | X | X | X |
| | | | Binocular | | | | | X | X | X | X | X |
| | (4 meters) | Photopic | Monocular | X | | | | X | X | X | X | X |
| | | | Binocular | | | | | X | X | X | X | X |
| | UCNVA (40 cm) | Photopic | Monocular | | | | | | X | X | X | |
| | | | Binocular | | | | | | X | X | X | |
| | BCNVA (40 cm) | Photopic | Monocular | | | | | | X | X | X | |
| | | | Binocular | | | | | | X | X | X | |
| | DCNVA (40 cm) | Photopic | Monocular | | | | | | X | X | X | |
| | | | Binocular | | | | | | X | X | X | |

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| | | | | Visit 0 | Visit 00 A | Visit 00 B | Visit 1 A/B | Visit 2 A/B | Visit 3 A/B | Visit 4 | Visit 5 | \( USV^2 \) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Examination | | Light Condition | Monocular / Binocular | Pre-Op / Screen D -90 to -1 | Implant A1 D 0 | Implant B1 (D 7 to D 30 after Visit 00 A) | Post-Op D 1-2 | Post-Op D 7-14 | Post-Op D 30-60 | Post-Op D 150-180 (from 1st eye) | Post-Op D 360-420 (from 1st eye) | N/A |
| | | Mesopic | Monocular | | | | | | X | X | X | |
| | | | Binocular | | | | | | X | X | X | |
| | BCIVA (80 cm) | Photopic | Monocular | | | | | | X | X | X | |
| | | | Binocular | | | | | | X | X | X | |
| | UCIVA (66 cm) | Photopic | Monocular | | | | | | X | X | X | |
| | | | Binocular | | | | | | | X | X | |
| | DCIVA (66 cm) | Photopic | Monocular | | | | | | X | X | X | |
| | | | Binocular | | | | | | | X | X | |
| | | Mesopic | Monocular | | | | | | X | X | X | |
| | | | Binocular | | | | | | | X | X | |
| | DCIVA (80 cm) | Photopic | Monocular | | | | | | X | X | X | |
| | | | Binocular | | | | | | | X | X | |
| | | Mesopic | Monocular | | | | | | X | X | X | |
| | | | Binocular | | | | | | | X | X | |
| | UCIVA (80 cm) | Photopic | Monocular | | | | | | X | X | X | |
| | | | Binocular | | | | | | | X | X | |
| Contrast Sensitivity with Glare - 2.5 meters | | Photopic | Monocular | | | | | | | X | X | |
| Contrast Sensitivity without Glare - 2.5 meters | | | | | | | | | | X | X | |
| Contrast Sensitivity with Glare - 2.5 meters | | Mesopic | Monocular | | | | | | | X | X | |
| Contrast Sensitivity without Glare - 2.5 meters | | | | | | | | | | X | X | |

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| | | | Visit 0 | Visit 00 A | Visit 00 B | Visit 1 A/B | Visit 2 A/B | Visit 3 A/B | Visit 4 | Visit 5 | \( USV^2 \) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Examination | Light Condition | Monocular / Binocular | Pre-Op / Screen D -90 to -1 | Implant A1 D 0 | Implant B1 (D 7 to D 30 after Visit 00 A) | Post-Op D 1-2 | Post-Op D 7-14 | Post-Op D 30-60 | Post-Op D 150-180 (from 1st eye) | Post-Op D 360-420 (from 1st eye) | N/A |
| Defocus Curve (Best Distance Corrected) – 4 meters6 | Monocular | | | | | | | X | X | | |
| | | Binocular | | | | | | | X | X | |

Abbreviations: ETDRS = Early Treatment Diabetic Retinopathy Study, UCDVA = Uncorrected Distance Visual Acuity, UCNVA = Uncorrected Near Visual Acuity, BCNVA = Best Corrected Near Visual Acuity, BCIVA = Best Corrected Intermediate Visual Acuity, UCIVA = Uncorrected Intermediate Visual Acuity

1 A - First Operative Eye, B - Second Operative Eye
2 USV - Unscheduled Visit; for unscheduled visits, mandatory assessments to be completed are defined in the table. Additional assessments may be performed as appropriate, based on the subject's condition.
3 Patient Reported Outcome Questionnaires include the PRSIQ, QoV and QoV Supplemental Questions
4 Pupil size measurements in mesopic and photopic lighting conditions must be taken right before contrast sensitivity testing (see instructions for Pupil Size Measurements in Manual of Procedures)
5 Subjects must be dilated for IOL axis of orientation assessment
6 Sites that are conducting rotational stability assessments will only perform monocular defocus curve testing on the first operative eye. Sites not conducting rotational stability assessments will perform binocular defocus curve testing

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3. Clinical Endpoints

With regards to safety:

- Co-primary safety objectives
- Estimate the cumulative rate of Secondary Surgical Interventions (SSIs) related to the optical properties of the IOL for the first operative eye up to Month 12 (Visit 5). Success was defined as the upper limit of the confidence interval being less than 0.014 (1.4%)
- Evaluate the mean monocular contrast sensitivity for the first operative eye, with and without glare for mesopic conditions and photopic conditions, at Month 12 (Visit 5). (No specific success criteria were pre-specified.)

- Secondary safety objectives
- Estimate rates of cumulative and persistent adverse events in first operative eyes at Month 12 (Visit 5) in comparison to the ISO Safety and Performance Endpoint (SPE) rates as described in ISO 11979-7. Success criteria for each type of event was a rate not statistically greater than the ISO SPE rate.
- Estimate visual disturbances using the Quality of Vision (QoV) questionnaire and QoV Supplemental Questions at Month 12 (Visit 5). (No specific success criteria were pre-specified.)

- Other Safety Endpoints
- All other AEs not specified by ISO SPE grid (which includes the Modified AAO Task Force AEs).
- Binocular defocus curve sub study at Visit 4 (6-months) and 5 (12-months)
- Manifest refraction at Visit 2 (1-2 weeks), 3 (1-month), 4, and 5
- Slit lamp examination findings at all study visits
- Device deficiencies
- Intraocular Pressure (IOP) at all study visits
- Dilated Fundus examination at Visit 3, 4, and 5
- Fundus visualization through multifocal IOL at Visit 3, 4, and 5

With regards to effectiveness:

- Co-primary effectiveness objectives:
- Demonstrate non-inferiority of FINEVISION HP Trifocal IOL to the control in mean photopic monocular Best Corrected Distance Visual Acuity (BCDVA) for the first operative eye at Month 6 (Visit 4). The success criterion was statistical non-inferiority of BCDVA compared to the control. The non-inferiority margin was set at 0.10 logMAR.

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○ Demonstrate superiority of FINEVISION HP Trifocal IOL to the control in mean photopic monocular Distance Corrected Near Visual Acuity (DCNVA) for the first operative eye at Month 6 (Visit 4). The success criterion was statistical superiority of DCNVA compared to the control. The superiority margin was set at 0.0 logMAR.

- The secondary effectiveness objective:

○ Demonstrate superiority of FINEVISION HP Trifocal IOL to the control in mean photopic monocular DCVA at intermediate (66 cm) for the first operative eye at Month 6 (Visit 4). The success criterion was statistical superiority of DCNVA compared to the control. The superiority margin was set at 0.0 logMAR.

- Additional effectiveness objectives (no specific success criteria were pre-specified):

○ Photopic monocular logMAR BCDVA, DCIVA (80 cm), DCIVA (66 cm), and DCNVA in first operative eyes at Month 6 (Visit 4) and Month 12 (Visit 5)

○ Mesopic monocular logMAR DCIVA (80 cm), DCIVA (66 cm), and DCNVA in first operative eyes at Month 6 (Visit 4) and Month 12 (Visit 5)

○ Photopic binocular logMAR BCDVA, DCIVA (80 cm), DCIVA (66 cm), and DCNVA at Month 6 (Visit 4) and Month 12 (Visit 5)

○ Mesopic binocular logMAR DCIVA (80 cm), DCIVA (66 cm), and DCNVA at Month 6 (Visit 4) and Month 12 (Visit 5)

○ Photopic monocular logMAR UCDVA, UCIVA (80 cm), UCIVA (66 cm), and UCNVA in first operative eyes at Month 6 (Visit 4) and Month 12 (Visit 5)

○ Photopic binocular logMAR UCDVA, UCIVA (80 cm), UCIVA (66 cm), and UCNVA at Month 6 (Visit 4) and Month 12 (Visit 5)

○ Photopic monocular logMAR BCIVA (80 cm) and BCNVA in first operative eyes at Month 6 (Visit 4) and Month 12 (Visit 5)

○ Photopic binocular logMAR BCIVA (80 cm) and BCNVA at Month 6 (Visit 4) and Month 12 (Visit 5)

○ Monocular and binocular defocus curves at Month 6 (Visit 4)

○ Spectacle Independence using the Patient-Reported Spectacle Independence Questionnaire (PRSIQ) at Month 6 (Visit 4).

With regard to success/failure criteria, all primary safety and effectiveness endpoints with success criteria were required to demonstrate statistical study success. Individual subject success was not defined.

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The following analyses sets were utilized in the study:

AAS (All Implanted analyses Set)- Includes all eyes with successful IOL implantation and at least one post-operative visit.

Best Case Set- Includes all eyes successfully implanted that had at least one postoperative visit and had no preoperative ocular pathology or macular degeneration at any time, and no major protocol deviations.

Intent-to-Treat (ITT) Set- Includes all randomized subjects (eyes).

Safety Analysis Set- Includes all subjects with at least one eye implanted with a study lens.

# B. Accountability of PMA Cohort

At the time of database lock, of 539 subjects enrolled in the PMA study, $92.6\%$ (474/512) subjects were available for analysis at the completion of the study, the 12-14-month postoperative visit. The disposition of 512 all randomized subjects is summarized in Table 9.

Table 9: Subject Disposition (All Enrolled Subjects)

| | FINEVISION HP n (%) | AcrySof SN60AT n (%) | All Subjects n (%) |
| --- | --- | --- | --- |
| Screened | | | 539 |
| Screen Failures Prior to Randomization | | | 27 |
| Randomized (N) | 341 | 171 | 512 |
| Implanted | 332 (97.4%) | 164 (95.9%) | 496 (96.9%) |
| Randomized But Not Implanted | 9 (2.6%) | 7 (4.1%) | 16 (3.1%) |
| Analysis Populations [1] | | | |
| Intent-to-Treat Set | 341 (100.0%) | 171 (100.0%) | 512 (100.0%) |
| All-Implanted Analysis Set | 332 (97.4%) | 164 (95.9%) | 496 (96.9%) |
| Best Case Set | 312 (91.5%) | 152 (88.9%) | 464 (90.6%) |
| Safety Set | 332 (97.4%) | 164 (95.9%) | 496 (96.9%) |
| Rotational Analysis Set | 148 (43.4%) | 0 | 148 (28.9%) |
| Completed Study | 315 (92.4%) | 159 (93.0%) | 474 (92.6%) |
| Discontinued | 26 (7.6%) | 10 (5.8%) | 36 (7.0%) |
| Reason for Discontinuation [2] | | | |
| Adverse Event | 0 | 0 | 0 |
| Death | 1 (3.8%) | 2 (20.0%) | 3 (8.3%) |
| Lost to Follow-up | 10 (38.5%) | 2 (20.0%) | 12 (33.3%) |
| Physician Decision | 0 | 0 | 0 |
| Protocol Deviation | 0 | 0 | 0 |
| Study Terminated by Sponsor | 0 | 0 | 0 |
| Withdrawal by Subject | 9 (34.6%) | 1 (10.0%) | 10 (27.8%) |
| Other | 6 (23.1%) | 5 (50.0%) | 11 (30.6%) |
| Protocol Deviations [3,4] | | | |

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| | FINEVISION HP n (%) | AcrySof SN60AT n (%) | All Subjects n (%) |
| --- | --- | --- | --- |
| Any Deviation | 148 (43.4%) | 60 (35.1%) | 208 (40.6%) |
| Major Deviation | 21 (6.2%) | 13 (7.6%) | 34 (6.6%) |
| Minor Deviation | 140 (41.6%) | 54 (31.6%) | 196 (38.3%) |

Abbreviations: IOL = Intraocular Lens; ITT = Intent-to-Treat.

Rotational Analysis Set (RAS)- Includes all subjects with successful FINEVISION HP Trifocal IOL implantation from a sub-set of clinical sites that examined subjects for rotational stability.

Note: Percentages are based on the number of randomized subjects in the respective treatment group unless otherwise stated. Two subjects (07-0730, 07-0735) who were randomized to the AcrySof SN60AT group and were not implanted with an IOL were recorded as screen failures per the protocol but were not recorded as discontinuations because they did not complete end of study case report forms.

[1] For the treatment assignments, ITT includes subjects as randomized, while all other populations include subjects as treated.
[2] Percentages are based on the number of subjects who discontinued for the respective treatment group.
[3] Classifications for all but eight deviations were assigned by the sponsor prior to database lock and unmasking. Of the eight deviations classified after unmasking, five deviations were inadvertently omitted from the deviation classification meetings prior to database lock, and three deviations were added to the database after lock. Of these eight deviations, three were classified as Major, which resulted in the exclusion of the respective three subjects, 05-0510, 06-0616, and 07-0718, from the Best-Case Set. The remaining five deviations were classified as Minor and had no impact on the Best-Case Set.
[4] Subjects with multiple deviations are only counted once in each category.

# 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 study population demographics and baseline parameters are reported in Tables 10 and 11. The demographic and baseline characteristics were similar between the two groups.

Table 10: Demographics (All implanted Analysis Set)

| Variable | FINEVISION HP (N=332) | AcrySof SN60AT (N=164) | All Subjects (N=496) |
| --- | --- | --- | --- |
| Age (years) | | | |
| Mean (SD) | 67.1 (7.41) | 67.8 (6.78) | 67.3 (7.21) |
| Median | 68.0 | 68.0 | 68.0 |
| Range | 40.0-80.0 | 40.0-80.0 | 40.0-80.0 |

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| Variable | FINEVISION HP (N=332) | AcrySof SN60AT (N=164) | All Subjects (N=496) |
| --- | --- | --- | --- |
| Min, Max | 41, 84 | 44, 90 | 41, 90 |
| Age Category: n (%) | | | |
| <65 years | 99 (29.8%) | 38 (23.2%) | 137 (27.6%) |
| >=65 years | 233 (70.2%) | 126 (76.8%) | 359 (72.4%) |
| Sex: n (%) | | | |
| Male | 121 (36.4%) | 62 (37.8%) | 183 (36.9%) |
| Female | 211 (63.6%) | 102 (62.2%) | 313 (63.1%) |
| Ethnicity: n (%) | | | |
| Hispanic or Latino | 27 (8.1%) | 7 (4.3%) | 34 (6.9%) |
| Not Hispanic or Latino | 305 (91.9%) | 157 (95.7%) | 462 (93.1%) |
| Race: n (%) | | | |
| American Indian or Alaska Native | 1 (0.3%) | 0 | 1 (0.2%) |
| Asian | 13 (3.9%) | 3 (1.8%) | 16 (3.2%) |
| Black or African American | 19 (5.7%) | 11 (6.7%) | 30 (6.0%) |
| Native Hawaiian or Other Pacific Islander | 1 (0.3%) | 1 (0.6%) | 2 (0.4%) |
| White | 294 (88.6%) | 148 (90.2%) | 442 (89.1%) |
| Other | 4 (1.2%) | 1 (0.6%) | 5 (1.0%) |
| Multi-Racial | 0 | 0 | 0 |

Note: N in the headers represents the number of subjects in the respective treatment group for the population being analyzed. Percentages are based on the number of subjects (N) in each respective treatment group. Subjects who selected more than one race are summarized in the Multi-Racial group. Age is calculated using the following equation: Age = (Informed Consent Date - Date of Birth) / 365.25, truncated as an integer.

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Table 11: Baseline Characteristics (All implanted Analysis Set)

| | FINEVISION HP (N=332) | | AcrySof SN60AT (N=164) | | All Subjects (N=496) | |
| --- | --- | --- | --- | --- | --- | --- |
| Variable | Right Eye (OD) | Left Eye (OS) | Right Eye (OD) | Left Eye (OS) | Right Eye (OD) | Left Eye (OS) |
| Potential Visual Acuity (logMAR) | | | | | | |
| n | 332 | 332 | 164 | 164 | 496 | 496 |
| Mean (SD) | 0.03 (0.056) | 0.03 (0.056) | 0.02 (0.047) | 0.02 (0.047) | 0.03 (0.053) | 0.03 (0.053) |
| Median | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 |
| Min, Max | 0.0, 0.2 | 0.0, 0.2 | 0.0, 0.2 | 0.0, 0.2 | 0.0, 0.2 | 0.0, 0.2 |
| Target Refraction Sphere (D) | | | | | | |
| n | 332 | 332 | 164 | 164 | 496 | 496 |
| Mean (SD) | -0.044 (0.1095) | -0.059 (0.1201) | -0.072 (0.1144) | -0.070 (0.1289) | -0.053 (0.1118) | -0.063 (0.1230) |
| Median | 0.000 | -0.020 | -0.040 | -0.030 | -0.020 | -0.030 |
| Min, Max | -0.34, 0.20 | -0.83, 0.17 | -0.44, 0.24 | -0.50, 0.20 | -0.44, 0.24 | -0.83, 0.20 |
| Target Refraction Cylinder (D) | | | | | | |
| n | 215 | 215 | 107 | 107 | 322 | 322 |
| Mean (SD) | 0.0 (0.00) | 0.0 (0.00) | 0.0 (0.00) | 0.0 (0.00) | 0.0 (0.00) | 0.0 (0.00) |
| Median | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
| Min, Max | 0, 0 | 0, 0 | 0, 0 | 0, 0 | 0, 0 | 0, 0 |
| Target Refraction Axis (deg) | | | | | | |
| n | 215 | 215 | 107 | 107 | 322 | 322 |
| Mean (SD) | 138.8 (75.08) | 138.7 (75.15) | 139.6 (75.43) | 139.6 (75.43) | 139.1 (75.08) | 139.0 (75.13) |
| Median | 180.0 | 180.0 | 180.0 | 180.0 | 180.0 | 180.0 |
| Min, Max | 0, 180 | 0, 180 | 0, 180 | 0, 180 | 0, 180 | 0, 180 |
| IOL Power Calculation (D) | | | | | | |
| n | 332 | 332 | 164 | 164 | 496 | 496 |
| Mean (SD) | 20.53 (3.092) | 20.55 (3.136) | 19.52 (2.671) | 19.63 (2.652) | 20.20 (2.995) | 20.24 (3.013) |
| Median | 21.00 | 21.00 | 20.00 | 20.00 | 20.50 | 20.50 |
| Min, Max | 11.0, 28.0 | 10.0, 27.5 | 11.0, 25.0 | 12.0, 25.0 | 11.0, 28.0 | 10.0, 27.5 |

Abbreviations: D = Diopters; deg = Degrees; IOL = Intraocular Lens; logMAR = Logarithm of the Minimum Angle of Resolution.
Note: N in the headers represents the number of subjects in the respective treatment group for the population being analyzed. Baseline refers to assessments performed during the Pre-Operative Visit.

# D. Safety and Effectiveness Results

# 1. Safety Results

The analysis of safety was based on the safety cohort of 496 implanted subjects: 332 FINEVISION HP Trifocal IOL subjects and 164 control subjects available for the 12-14-

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month evaluation. The key safety outcomes for this study are presented below in Tables 12 to16 and Figures 5 to 8. Adverse events are reported in Tables 17 to 20.

The first co-primary safety endpoints were to estimate the cumulative rate of Secondary Surgical Interventions (SSIs) related to the optical properties of the IOL for the first operative eye up to Month 12 (Visit 5). (Table 12)

The second co-primary safety endpoint was to evaluate the mean monocular contrast sensitivity for the first operative eye, with and without glare for mesopic conditions and photopic conditions, at Month 12 (Visit 5). (Figures 5 to 8)

There were two secondary co-primary endpoints. The first was to estimate rates of cumulative and persistent adverse events in first operative eyes at Month 12 (Visit 5) in comparison to the ISO Safety and Performance Endpoint (SPE) rates as described in ISO 11979-7 (Table13). The second was to estimate visual disturbances using the Quality of Vision (QoV) questionnaire and QoV Supplemental Questions at Month 12 (Visit 5). (Tables 17 to 19).

## SSI related to the optical properties of the IOLs

The first co-primary safety objective was to estimate the cumulative rate of secondary surgical interventions (SSIs) related to the optical properties of the IOL for the first operative eyes through Month 12 (Visit 5). Noninferiority of FINEVISION HP Trifocal IOL compared to AcrySof SN60AT IOL in the proportions of first operative eyes with secondary surgical interventions related to the optical properties of the IOL was evaluated using two-sided 90% Farrington method confidence intervals around the difference in proportions between the FINEVISION HP Trifocal IOL and AcrySof SN60AT IOL. Success was defined as the upper limit of the confidence interval being less than 0.014 (1.4%). Results of the cumulative rate of SSIs related to the optical properties of the IOL in first operative eyes through Month 12 (Visit 5) are shown in Table 12. Only one SSI related to the optical properties of the IOLs was reported in the clinical study. In the first operative eye for a FINEVISION HP Trifocal IOL subject, there was an explant of the IOL due to subjective complaints of dissatisfaction with the level of vision. The analysis demonstrates that the FINEVISION HP Trifocal IOL is considered statistically non-inferior to the AcrySof SN60AT IOL in rate of SSIs related to the optical properties of the IOL.

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Table 12: Cumulative Secondary Surgical Interventions Related to the Optical Properties of the IOL, Safety Set – First Operative Eyes up to Month 12 (Visit 5)

| | FINEVISION HP (N=332) | AcrySof SN60AT (N=164) |
| --- | --- | --- |
| Any Secondary Surgical Interventions Related to the Optical Properties of the IOL: n (%) | 1 (0.3) | 0 |
| Difference in Percentages | 0.3 | |
| 90% CI for Difference in Percentages [1] | (-0.76, 1.36) | |

Abbreviations: IOL = Intraocular Lens.

Note: N in the headers represents the number of eyes in the respective treatment group for the population being analyzed. Percentages are based on the number of eyes (N) in each respective treatment group for the population being analyzed.

[1] Confidence interval (CI) computed using the Farrington-Manning method.

## Contrast Sensitivity

The second co-primary safety objective was to evaluate the mean monocular contrast sensitivity for the first operative eye with and without glare for photopic and mesopic conditions at Month 12 (Visit 5).

Contrast sensitivity was measured monocularly at Month 12 (Visit 5) under four conditions: photopic without glare, photopic with glare, mesopic without glare, and mesopic with glare, using the M&amp;S System (Clinical Trial Suite, M&amp;S Technologies, Niles, IL, USA) for sine-wave gratings 1.5, 3, 6, 12 and/or 18 cycles per degree (CPD) at a test distance of 2.5 meters. The luminance for photopic testing was $85~\mathrm{cd / m^2}$ . For mesopic testing, a neutral density filter was placed in front of the screen to reduce lighting to $3 + / - 0.5~\mathrm{cd / m^2}$ . In all testing conditions, mean monocular distance contrast sensitivity (mesopic with and without glare at 1.5, 3, 6, and 12 cycles per degree (cpd) measured at $2.5\mathrm{m}$ , and photopic with and without glare at 3, 6, 12, and 18 cpd, measured at $2.5\mathrm{m}$ ) was slightly better for eyes in the monofocal IOL group than in the FINEVISION HP Trifocal IOL group in first operative eyes at Month 12 (Visit 5), however, the difference in means was not clinically significant. The results are shown for the best-case set in Figures 5-8. More positive outcomes are indicative of better performance.

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Figure 5: Mean Monocular Log Contrast Sensitivity at Month 12 with $95\%$ CIs for Means, Best Case Set - First Operative Eyes
Light Condition: Photopic Without Glare

Abbreviations: cpd = Cycles per Degree.

Note: Numbers at bottom of figure are the number of subjects with non-missing data for the respective treatment group and sine-wave grating level. Raw data were collected as log10(contrast threshold) which were converted to log contrast sensitivities representing -log10(contrast threshold). $95\%$ confidence intervals for means are based on the t-distribution.

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Figure 6: Mean Monocular Log Contrast Sensitivity at Month 12 with 95% CIs for Means, Best Case Set – First Operative Eyes
Light Condition: Photopic with Glare

Abbreviations: cpd = Cycles per Degree.

Note: Numbers at bottom of figure are the number of subjects with non-missing data for the respective treatment group and sine-wave grating level. Raw data were collected as log10(contrast threshold) which were converted to log contrast sensitivities representing -log10(contrast threshold). 95% confidence intervals for means are based on the t-distribution.

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Figure 7: Mean Monocular Log Contrast Sensitivity at Month 12 with $95\%$ CIs for Means, Best Case Set - First Operative Eyes
Light Condition: Mesopic without Glare

Abbreviations: cpd = Cycles per Degree.

Note: Numbers at bottom of figure are the number of subjects with non-missing data for the respective treatment group and sine-wave grating level. Raw data were collected as log10(contrast threshold) which were converted to log contrast sensitivities representing -log10(contrast threshold). $95\%$ confidence intervals for means are based on the t-distribution.

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Figure 8: Mean Monocular Log Contrast Sensitivity at Month 12 with $95\%$ CIs for Means, Best Case Set - First Operative Eyes
Light Condition: Mesopic with Glare

Abbreviations: cpd = Cycles per Degree.

Note: Numbers at bottom of figure are the number of subjects with non-missing data for the respective treatment group and sine-wave grating level. Raw data were collected as log10(contrast threshold) which were converted to log contrast sensitivities representing -log10(contrast threshold). 95% confidence intervals for means are based on the t-distribution.

# Cumulative and Persistent Adverse events rate

The first secondary safety objective was to evaluate rates of cumulative and persistent adverse events in first operative eyes at Month 12 (Visit 5) in comparison to the ISO Safety and Performance Endpoint (SPE) rates as described in ISO 11979-7.

The results are provided in Tables 13-14. If the same event occurred multiple times in an eye, only the first occurrence is counted in the table below. All SPE rates for FINEVISION HP Trifocal IOL or the control group were below the SPE threshold as set forth by ISO 11979-7.

Table 13: Cumulative and Persistent Adverse Events, Safety Set - First Implanted Eyes

| Adverse Event | SPE Rate (%) [3] | FINEVISION HP (N=332) (m=315) | | |
| --- | --- | --- | --- | --- |
| | | n (%) | 2-sided 95% CI [4] | 1-sided 95% Lower CL [4] |
| Cumulative | | | | |
| Cystoid macular edema | 3.0 | 1 | (0.01, 1.67) | 0.02 |

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Abbreviations: CL = Confidence Limit; IOL = Intraocular Lens; IOP = Intraocular Pressure; SPE = Safety and Performance Endpoints.

Note: At each level of summarization, n represents the number of unique subjects with at least one specific event. Cumulative AEs are AEs which occur at any time during the study. If a subject experiences a specific cumulative AE more than once during the study, it is counted once for that specific cumulative AE. Percentages for cumulative AEs are based on the number of subjects (N) in each respective treatment group for the population being analyzed. Persistent AEs are AEs which are classified as ongoing at the time of study exit for subjects seen at Visit 5 (Day 360 to 420). A subject is counted once for a specific persistent AE. Percentages for persistent AEs are based on the number of subjects (m) seen at Visit 5 (Day 360 to 420) in each respective treatment group for the population being analyzed.

[1] Endophthalmitis is defined as inflammatory reaction (sterile or infectious) involving the vitreous body.
[2] Excludes posterior capsulotomies.
[3] The SPE rate is from Table E.2 (Posterior chamber IOL adverse event rates) of ISO 11979-7:2018(E).
[4] Confidence intervals and confidence limits for adverse event rates are computed using the Clopper-Pearson method.

Table 14: Cumulative and Persistent Adverse Events, Safety Set – Second Implanted Eyes

| Adverse Event | SPE Rate (%) [3] | FINEVISION HP (N=329) (m=314) | | |
| --- | --- | --- | --- | --- |
| | | n (%) | 2-sided 95% CI [4] | 1-sided 95% Lower CL [4] |
| Cumulative | | | | |
| Cystoid macular edema | 3.0 | 5 (1.5% [5/329]) | (0.50, 3.51) | 0.60 |
| Hypopyon | 0.3 | 0 | (0.00, 1.11) | 0.00 |
| Endophthalmitis [1] | 0.1 | 0 | (0.00, 1.11) | 0.00 |
| Lens dislocated from posterior chamber | 0.1 | 0 | (0.00, 1.11) | 0.00 |
| Pupillary block | 0.1 | 0 | (0.00, 1.11) | 0.00 |
| Retinal detachment | 0.3 | 2 | (0.07, 2.18) | 0.11 |
| Secondary surgical intervention [2] | 0.8 | 6 (1.8% [6/332]) | (0.67, 3.89) | 0.79 |
| Persistent | | | | |
| Corneal stroma edema | 0.3 | 0 | (0.00, 1.16) | 0.00 |
| Cystoid macular edema | 0.5 | 0 | (0.00, 1.16) | 0.00 |
| Iritis | 0.3 | 0 | (0.00, 1.16) | 0.00 |
| Raised IOP requiring treatment | 0.4 | 0 | (0.00, 1.16) | 0.00 |

Note: At each level of summarization, n represents the number of unique subjects with at least one specific event. Cumulative AEs are AEs which occur at any time during the study. If a subject experiences a specific cumulative AE more than once during the study, it is counted once for that specific cumulative AE. Percentages for cumulative AEs are based on the number of subjects (N) in each respective treatment group for the population being analyzed. Persistent AEs are AEs which are classified as ongoing at the time of study exit for subjects seen at Visit 5 (Day 360 to 420). A subject is counted once for a specific persistent AE. Percentages for persistent AEs are based on the number of subjects (m) seen at Visit 5 (Day 360 to 420) in each respective treatment group for the population being analyzed.

[1] Endophthalmitis is defined as inflammatory reaction (sterile or infectious) involving the vitreous body.
[2] Excludes posterior capsulotomies.
[3] The SPE rate is from Table E.2 (Posterior chamber IOL adverse event rates) of ISO 11979-7:2018(E).
[4] Confidence intervals and confidence limits for adverse event rates are computed using the Clopper-Pearson method.

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Table 15: Secondary Surgical Interventions by Category – Safety Set – First Operative Eyes

| SSI Category | FINEVISION HP (N=332) n (%) | AcrySof® SN60AT (N=164) n (%) |
| --- | --- | --- |
| Any SSI | 8 (2.4) | 4 (2.4) |
| | | |
| Anterior chamber reinflation | 0 | 1 (0.6) |
| IOL removal | 1 (0.3) | 0 |
| Lens material removal | 1 (0.3) | 0 |
| Paracentesis | 2 (0.6) | 1 (0.6) |
| Re-suturing of main incision | 0 | 1 (0.6) |
| Retinal laser | 0 | 0 |

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| SSI Category | FINEVISION HP (N=332) n (%) | AcrySof® SN60AT (N=164) n (%) |
| --- | --- | --- |
| Vitrectomy | 4 (1.2) | 1 (0.6) |
| Abbreviations: IOL=Intraocular Lens; SSI = Secondary Surgical Intervention Note: Percentages are based on the number of eyes (N) in the respective treatment group for the population being analyzed. | | |

Table 16: Secondary Surgical Interventions by Category – Safety Set – Second Operative Eyes

| SSI Category | FINEVISION HP (N=329) n (%) | AcrySof® SN60AT (N=164) n(%) |
| --- | --- | --- |
| Any SSI | 6 (1.8) | 2 (1.2) |
| | | |
| Anterior chamber reinflation | 0 | 0 |
| IOL removal | 0 | 0 |
| Lens material removal | 0 | 0 |
| Paracentesis | 3 (0.9) | 2 (1.2) |
| Re-suturing of main incision | 0 | 0 |
| Retinal laser | 1 (0.3) | 0 |
| Vitrectomy | 2 (0.6) | 0 |
| Abbreviations: IOL=Intraocular Lens; SSI = Secondary Surgical Intervention. Note: At each level of summarization, n represents the number of unique eyes with at least one specific SSI. Percentages are based on the number of eyes (N) in the respective treatment group for the population being analyzed. | | |

# Visual Disturbances

The second secondary safety objective was to estimate the rates of Visual disturbances using the Quality of Vision (QoV) questionnaire and QoV Supplemental Questions at Month 12 (Visit 5). Table 17-19 report rates of visual disturbances in FINEVISION HP Trifocal IOL and Control groups. Most visual symptoms—such as glare, hazy or blurred vision, image distortion, double or multiple images, trouble focusing, difficulty judging distance or depth, and vision fluctuations—occurred at similar or slightly lower rates in the FINEVISION HP Trifocal IOL group compared to the control group. However, two symptoms—starbursts and halos—were reported more frequently by participants with the FINEVISION HP Trifocal IOL than those with the monofocal control lens.

Outcomes of the QoV Supplemental Questions at Month 12 (Visit 5) overall showed that subjects favored the trifocal IOL for near vision and slightly favored the monofocal IOL for distance vision. Perceived trouble with night driving was lower in the monofocal IOL group by a moderate margin, and trouble with color disturbances was comparable between the study groups. A larger proportion

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of participants reported they would have this device implanted again in the FINEVISION HP Trifocal IOL group as compared to the control group.

Table 17: Quality of Vision (QoV) categorical summary of the frequency of each visual disturbance at Visit 5 (Day 360 to 420), Safety Set

| | FINEVISION HP (%) | | | | | Monofocal (%) | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Visual Disturbance | N | Never | Occasionally | Quite Often | Very Often | N | Never | Occasionally | Quite Often | Very Often |
| Glare | 315 | 38.4% [121/315] | 47.3% [149/315] | 11.1% [35/315] | 3.2% [10/315] | 159 | 38.4% [61/159] | 51.6% [82/159] | 8.2% [13/159] | 1.9% [3/159] |
| Haloes | 315 | 22.2% [70/315] | 39.0% [123/315] | 21.0% [66/315] | 17.8% [56/315] | 159 | 70.4% [112/159] | 23.3% [37/159] | 3.8% [6/159] | 2.5% [4/159] |
| Starbursts | 315 | 50.2% [158/315] | 31.4% [99/315] | 11.7% [37/315] | 6.7% [21/315] | 159 | 61.6% [98/159] | 30.8% [49/159] | 5.7% [9/159] | 1.9% [3/159] |
| Hazy Vision | 315 | 67.9% [214/315] | 24.4% [77/315] | 5.1% [16/315] | 2.5% [8/315] | 159 | 67.3% [107/159] | 24.5% [39/159] | 5.7% [9/159] | 2.5% [4/159] |
| Blurred Vision | 315 | 61.3% [193/315] | 32.7% [103/315] | 4.8% [15/315] | 1.3% [4/315] | 159 | 50.9% [81/159] | 38.4% [61/159] | 8.2% [13/159] | 2.5% [4/159] |
| Distortion | 315 | 90.5% [285/315] | 8.6% [27/315] | 1.0% [3/315] | 0.0% | 159 | 91.8% [146/159] | 5.7% [9/159] | 2.5% [4/159] | 0.0% |
| Double or multiple images | 315 | 88.6% [279/315] | 10.5% [33/315] | 0.6% [2/315] | 0.3% [1/315] | 159 | 88.7% [141/159] | 9.4% [15/159] | 1.3% [2/159] | 0.6% [1/159] |
| Fluctuation in Vision | 315 | 48.3% [152/315] | 42.5% [134/315] | 7.3% [23/315] | 1.9% [6/315] | 159 | 50.3% [80/159] | 44.0% [70/159] | 3.8% [6/159] | 1.9% [3/159] |
| Focusing Difficulties | 315 | 44.1% [139/315] | 47.9% [151/315] | 5.4% [17/315] | 2.5% [8/315] | 159 | 39.6% [63/159] | 46.5% [74/159] | 9.4% [15/159] | 4.4% [7/159] |
| Difficulty Judging Distance or Depth Perception | 315 | 73.7% [232/315] | 19.0% [60/315] | 4.4% [14/315] | 2.9% [9/315] | 159 | 66.0% [105/159] | 25.8% [41/159] | 6.3% [10/159] | 1.9% [3/159] |
| Note: Percentages are based on the number of subjects (N) seen at Visit 5 (Day 360 to 420) for the respective treatment group for the population being analyzed. | | | | | | | | | | |

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Table 18: Quality of Vision (QoV) categorical summary of the severity of each visual disturbance at Visit 5 (Day 360 to 420) excluding subjects who reported frequency of "Never", Safety Set

| | FINEVISION HP (%) | | | | | | Monofocal (%) | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Visual Disturbance | N | Not at all | Mild | Moderate | Severe | Missing | N | Not at all | Mild | Moderate | Severe | Missing |
| Glare | 194 | 4.1% [8/194] | 67.0% [130/194] | 24.7% [48/194] | 3.6% [7/194] | 0.5% [1/194] | 98 | 6.1% [6/98] | 59.2% [58/98] | 31.6% [31/98] | 3.1% [3/98] | 0.0% |
| Haloes | 245 | 3.3% [8/245] | 52.7% [129/245] | 33.9% [83/245] | 9.8% [24/245] | 0.4% [1/245] | 47 | 6.4% [3/47] | 70.2% [33/47] | 21.3% [10/47] | 2.1% [1/47] | 0.0% |
| Starbursts | 157 | 8.3% [13/157] | 54.8% [86/157] | 31.2% [49/157] | 5.7% [9/157] | 0.0% | 61 | 8.2% [5/61] | 65.6% [40/61] | 23.0% [14/61] | 3.3% [2/61] | 0.0% |
| Hazy Vision | 101 | 7.9% [8/101] | 65.3% [66/101] | 24.8% [25/101] | 1.0% [1/101] | 1.0% [1/101] | 52 | 7.7% [4/52] | 71.2% [37/52] | 15.4% [8/52] | 5.8% [3/52] | 0.0% |
| Blurred Vision | 122 | 7.4% [9/122] | 73.0% [89/122] | 17.2% [21/122] | 2.5% [3/122] | 0.0% | 78 | 3.8% [3/78] | 66.7% [52/78] | 24.4% [19/78] | 5.1% [4/78] | 0.0% |
| Distortion | 30 | 13.3% [4/30] | 73.3% [22/30] | 13.3% [4/30] | 0.0% | 0.0% | 13 | 7.7% [1/13] | 69.2% [9/13] | 23.1% [3/13] | 0.0% | 0.0% |
| Double or multiple images | 36 | 8.3% [3/36] | 83.3% [30/36] | 8.3% [3/36] | 0.0% | 0.0% | 18 | 11.1% [2/18] | 61.1% [11/18] | 16.7% [3/18] | 11.1% [2/18] | 0.0% |
| Fluctuation in Vision | 163 | 9.2% [15/163] | 69.9% [114/163] | 17.8% [29/163] | 2.5% [4/163] | 0.6% [1/163] | 79 | 8.9% [7/79] | 75.9% [60/79] | 12.7% [10/79] | 2.5% [2/79] | 0.0% |
| Focusing Difficulties | 176 | 12.5% [22/176] | 69.9% [123/176] | 14.8% [26/176] | 2.8% [5/176] | 0.0% | 96 | 2.1% [2/96] | 71.9% [69/96] | 21.9% [21/96] | 4.2% [4/96] | 0.0% |
| Difficulty Judging Distance or Depth Perception | 83 | 8.4% [7/83] | 68.7% [57/83] | 19.3% [16/83] | 3.6% [3/83] | 0.0% | 54 | 1.9% [1/54] | 68.5% [37/54] | 27.8% [15/54] | 1.9% [1/54] | 0.0% |
| Note: Percentages are based on the number of subjects (N) seen at Visit 5 (Day 360 to 420) who did not report a frequency of “Never” for the visual disturbance and treatment group for the population being analyzed. | | | | | | | | | | | | |

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Table 19: Quality of Vision (QoV) categorical summary of the bothersomeness of each visual disturbance at Visit 5 (Day 360 to 420) excluding subjects who reported frequency of “Never”, Safety Set

| | FINEVISION HP (%) | | | | | | Monofocal (%) | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Visual Disturbance | N | Not at all | A little | Quite | Very | Missing | N | Not at all | A little | Quite | Very | Missing |
| Glare | 194 | 15.5% [30/194] | 67.5% [131/194] | 10.8% [21/194] | 5.7% [11/194] | 0.5% [1/194] | 98 | 17.3% [17/98] | 62.2% [61/98] | 15.3% [15/98] | 5.1% [5/98] | 0.0% |
| Haloes | 245 | 23.7% [58/245] | 47.3% [116/245] | 18.0% [44/245] | 10.6% [26/245] | 0.4% [1/245] | 47 | 25.5% [12/47] | 59.6% [28/47] | 12.8% [6/47] | 2.1% [1/47] | 0.0% |
| Starbursts | 157 | 24.2% [38/157] | 46.5% [73/157] | 21.7% [34/157] | 7.6% [12/157] | 0.0% | 61 | 21.3% [13/61] | 65.6% [40/61] | 9.8% [6/61] | 3.3% [2/61] | 0.0% |
| Hazy Vision | 101 | 15.8% [16/101] | 63.4% [64/101] | 16.8% [17/101] | 4.0% [4/101] | 0.0% | 52 | 21.2% [11/52] | 57.7% [30/52] | 13.5% [7/52] | 7.7% [4/52] | 0.0% |
| Blurred Vision | 122 | 12.3% [15/122] | 68.0% [83/122] | 16.4% [20/122] | 3.3% [4/122] | 0.0% | 78 | 12.8% [10/78] | 57.7% [45/78] | 20.5% [16/78] | 9.0% [7/78] | 0.0% |
| Distortion | 30 | 23.3% [7/30] | 60.0% [18/30] | 16.7% [5/30] | 0.0% | 0.0% | 13 | 15.4% [2/13] | 53.8% [7/13] | 30.8% [4/13] | 0.0% | 0.0% |
| Double or multiple images | 36 | 22.2% [8/36] | 66.7% [24/36] | 8.3% [3/36] | 2.8% [1/36] | 0.0% | 18 | 11.1% [2/18] | 61.1% [11/18] | 16.7% [3/18] | 11.1% [2/18] | 0.0% |
| Fluctuation in Vision | 163 | 23.9% [39/163] | 63.8% [104/163] | 8.6% [14/163] | 3.1% [5/163] | 0.6% [1/163] | 79 | 16.5% [13/79] | 63.3% [50/79] | 13.9% [11/79] | 6.3% [5/79] | 0.0% |
| Focusing Difficulties | 176 | 21.0% [37/176] | 61.9% [109/176] | 11.9% [21/176] | 4.5% [8/176] | 0.6% [1/176] | 96 | 12.5% [12/96] | 66.7% [64/96] | 15.6% [15/96] | 5.2% [5/96] | 0.0% |
| Difficulty Judging Distance or Depth Perception | 83 | 10.8% [9/83] | 68.7% [57/83] | 14.5% [12/83] | 6.0% [5/83] | 0.0% | 54 | 5.6% [3/54] | 74.1% [40/54] | 13.0% [7/54] | 7.4% [4/54] | 0.0% |
| Note: Percentages are based on the number of subjects (N) seen at Visit 5 (Day 360 to 420) who did not report a frequency of “Never” for the visual disturbance and treatment group for the population being analyzed. | | | | | | | | | | | | |

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# Adverse events that occurred in the PMA clinical study:

The ocular treatment-emergent adverse events (TEAEs; serious and non-serious) for both the study and control lens, first eye, are presented in Table 20. The most common ocular TEAEs overall were vitreous detachment and increased IOP, which were observed at comparable rates between study and treatments groups (6.1% [40/661] vs 7.6% [25/328] and 3.9% [26/661] vs 4.3% [14/328], respectively). Other TEAEs observed at rates from 1-2% in the study group were corneal dystrophy, iritis, punctate keratitis, meibomian gland dysfunction, and dry eye. In the AcrySof SN60AT IOL group, punctate keratitis was reported in 2.7% [9/328] of eyes. There were no non-ocular TEAEs reported in more than 1% of subjects. Results for the second eyes were similar to the first eyes (Table 21).

Table 20: Ocular Treatment-Emergent Adverse Events by Preferred Term, Safety Set – First Operative Eyes

| Preferred Term (PT) | FINEVISION HP
(N=332)
n (%) | AcrySof SN60AT
(N=164)
n (%) |
| --- | --- | --- |
| Any Ocular TEAE | 86 (25.9) | 33 (20.1) |
| Vitreous detachment | 17 (5.1) | 13 (7.9) |
| Intraocular pressure increased | 12 (3.6) | 7 (4.3) |
| Iritis | 6 (1.8) | 1 (0.6) |
| Punctate keratitis | 6 (1.8) | 5 (3.0) |
| Conjunctival hemorrhage | 4 (1.2) | 0 |
| Dry eye | 4 (1.2) | 1 (0.6) |
| Meibomian gland dysfunction | 4 (1.2) | 0 |
| Corneal dystrophy | 3 (0.9) | 1 (0.6) |
| Blepharitis | 3 (0.9) | 0 |
| Conjunctivitis allergic | 3 (0.9) | 0 |
| Retinal detachment | 3 (0.9) | 0 |
| Punctal plug insertion | 3 (0.9) | 0 |
| Vitrectomy | 3 (0.9) | 0 |
| Conjunctivitis | 2 (0.6) | 0 |
| Conjunctivitis viral | 2 (0.6) | 0 |
| Diabetic retinopathy | 2 (0.6) | 1 (0.6) |

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| Preferred Term (PT) | FINEVISION HP (N=332) n (%) | AcrySof SN60AT (N=164) n (%) |
| --- | --- | --- |
| Eye pain | 2 (0.6) | 0 |
| Macular hole | 2 (0.6) | 1 (0.6) |
| Retinal degeneration | 2 (0.6) | 0 |
| Retinal depigmentation | 2 (0.6) | 2 (1.2) |
| Vitreous floaters | 2 (0.6) | 1 (0.6) |
| Tilted disc syndrome | 1 (0.3) | 0 |
| Conjunctival hyperemia | 1 (0.3) | 0 |
| Conjunctival edema | 1 (0.3) | 0 |
| Conjunctivochalasis | 1 (0.3) | 0 |
| Corneal deposits | 1 (0.3) | 0 |
| Corneal epithelium defect | 1 (0.3) | 0 |
| Cystoid macular edema | 1 (0.3) | 1 (0.6) |
| Dermatochalasis | 1 (0.3) | 0 |
| Eye irritation | 1 (0.3) | 0 |
| Eye pruritus | 1 (0.3) | 0 |
| Eyelid ptosis | 1 (0.3) | 0 |
| Glare | 1 (0.3) | 0 |
| Halo vision | 1 (0.3) | 0 |
| Iris transillumination defect | 1 (0.3) | 0 |
| Keratic precipitates | 1 (0.3) | 0 |
| Herpes ophthalmic | 1 (0.3) | 0 |
| Hordeolum | 1 (0.3) | 0 |
| Cataract operation complication | 1 (0.3) | 1 (0.6) |
| Foreign body in eye | 1 (0.3) | 0 |
| Periorbital hemorrhage | 1 (0.3) | 0 |
| Basal cell carcinoma | 1 (0.3) | 0 |
| Lens extraction | 1 (0.3) | 0 |

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| Preferred Term (PT) | FINEVISION HP
(N=332)
n (%) | AcrySof SN60AT
(N=164)
n (%) |
| --- | --- | --- |
| Scleral buckling surgery | 1 (0.3) | 0 |
| Lacrimation disorder | 1 (0.3) | 0 |
| Optic disc hemorrhage | 1 (0.3) | 0 |
| Retinal drusen | 1 (0.3) | 0 |
| Retinal hemorrhage | 1 (0.3) | 0 |
| Visual acuity reduced | 1 (0.3) | 0 |
| Vitreous prolapse | 1 (0.3) | 0 |
| Vitritis | 1 (0.3) | 0 |
| Anterior capsule contraction | 0 | 1 (0.6) |
| Diplopia | 0 | 1 (0.6) |
| Epiretinal membrane | 0 | 1 (0.6) |
| Exposure keratitis | 0 | 1 (0.6) |
| Flat anterior chamber of eye | 0 | 1 (0.6) |
| Vitreous degeneration | 0 | 1 (0.6) |
| Ophthalmic herpes simplex | 0 | 1 (0.6) |
| Corneal abrasion | 0 | 1 (0.6) |
| Retinal operation | 0 | 1 (0.6) |

Abbreviations: MedDRA = Medical Dictionary for Regulatory Activities; PT = Preferred Term; TEAE = Treatment-Emergent Adverse Event.

Note: At each level of summarization, n represents the number of unique eyes with at least one specific event. Percentages are based on the number of eyes (N) in the respective treatment group for the population being analyzed. Ocular TEAEs for a respective eye include all AEs occurring or worsening during or after the operation for the respective eye. Adverse events are coded using MedDRA Version 24.1. PTs are listed in order of descending frequency for the FINEVISION HP Trifocal IOL group.

PMA (P240038): FDA Summary of Safety and Effectiveness Data

{41}

Table 21: Ocular Treatment-Emergent Adverse Events by Preferred Term, Safety Set – Second Operative Eyes

| Preferred Term (PT) | FINEVISION HP
(N=329)
n (%) | AcrySof SN60AT
(N=164)
n (%) |
| --- | --- | --- |
| Any Ocular TEAE | 81 (24.6) | 31 (18.9) |
| Vitreous detachment | 23 (7.0) | 12 (7.3) |
| Intraocular pressure increased | 14 (4.3) | 7 (4.3) |
| Cystoid macular edema | 5 (1.5) | 2 (1.2) |
| Iritis | 5 (1…