← Product Code [MFK](/productcode/MFK) · P060011S045

# RayOne Galaxy; Model RAO605G, RayOne Galaxy Toric; Model RAO615X (P060011S045)

_Rayner Intraocular Lenses , Ltd. · MFK · Sep 24, 2026 · Ophthalmic · APPR_

**Canonical URL:** https://fda.innolitics.com/device/P060011S045

## Device Facts

- **Applicant:** Rayner Intraocular Lenses , Ltd.
- **Product Code:** [MFK](/productcode/MFK.md)
- **Decision Date:** Sep 24, 2026
- **Decision:** APPR
- **Regulation:** 21 CFR 886.3600
- **Device Class:** Class 3
- **Review Panel:** Ophthalmic
- **Attributes:** Therapeutic

## Indications for Use

RayOne Galaxy (Model RAO605G) is intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia, in adult patients in whom a cataractous lens has been removed. The IOL mitigates the effects of presbyopia by providing improved intermediate and near visual acuity while maintaining comparable distance visual acuity to a monofocal IOL. RayOne Galaxy is intended for implantation in patients with less than 1.00 diopter of pre-existing corneal astigmatism. The RayOne injection system is used to fold and assist in inserting the IOL into the eye. RayOne Galaxy Toric (Model RAO615X) is intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia, in adult patients in whom a cataractous lens has been removed. The IOL mitigates the effects of presbyopia by providing improved intermediate and near visual acuity while maintaining comparable distance visual acuity to a monofocal IOL. In addition, RayOne Galaxy Toric is intended to provide reduction of residual refractive astigmatism in patients with corneal astigmatism greater than or equal to 1.03 diopter, up to 3.07 diopter. The RayOne injection system is used to fold and assist in inserting the IOL into the eye.

## Device Story

RayOne Galaxy and Galaxy Toric are multifocal (trifocal) intraocular lenses (IOLs) designed to mitigate presbyopia by extending vision from distance to near. The IOLs feature a biconvex optic with a refractive spiral anterior surface and an aspheric posterior surface (toric for the Galaxy Toric model). The devices are preloaded in a RayOne injection system for implantation into the capsular bag by an ophthalmologist during cataract surgery. The spiral optic provides intermediate (+1.5 D) and near (+3.0 D) add powers. The device improves intermediate and near visual acuity while maintaining distance acuity comparable to monofocal IOLs. The Galaxy Toric model additionally reduces residual refractive astigmatism. Clinical outcomes are assessed by the surgeon post-operatively to ensure visual acuity targets are met. The device benefits patients by reducing dependence on spectacles for near and intermediate tasks following cataract extraction.

## Clinical Evidence

Prospective, multicenter, randomized, active-controlled, masked pivotal study (IDE G210105) with 230 randomized subjects. Primary endpoints: mean photopic monocular BCDVA at 4m (≤0.20 logMAR) and photopic monocular DCNVA at 40cm (superiority vs. monofocal control). Results: Mean BCDVA was 0.031 logMAR; DCNVA was significantly better in the multifocal group (-0.275 logMAR difference, p<0.0001). Safety endpoints met ISO 11979-7:2024 criteria. Adverse event rates were comparable to the monofocal control. No secondary surgical interventions related to optical properties were required.

## Technological Characteristics

Materials: Rayacryl (hydrophilic acrylic). Design: Multifocal (trifocal) refractive spiral optic, biconvex, 6.0 mm optic diameter, 12.5 mm overall diameter. Haptic: Closed C-loop. Edge: 360° posterior Enhanced Square Edge. Energy: Passive optical. Connectivity: None. Sterilization: Moist heat. Standards: ISO 11979-2 (optical), ISO 11979-3 (mechanical), ISO 11979-5 (biocompatibility), ANSI Z80.30 (toric).

## Regulatory 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

- RayOne Aspheric ([P060011](/device/P060011.md)/S014)
- RayOne EMV Toric ([P060011](/device/P060011.md)/S039)

## Reference Devices

- C-flex 570C IOL (G020115)
- Centerflex IOL

## Submission Summary (Full Text)

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>
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# SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED)

# I. GENERAL INFORMATION

Device Generic Name: Intraocular Lens

Device Trade Name: RayOne Galaxy; Model RAO605G
RayOne Galaxy Toric; Model RAO615X

Device Procode: MFK, MJP

Applicant's Name and Address: Rayner Intraocular Lenses Limited
The Ridley Innovation Centre
10 Dominion Way, Worthing, West Sussex
BN14 8AQ, United Kingdom

Date(s) of Panel Recommendation: None

Premarket Approval Application (PMA) Number: P060011/S045

Date of FDA Notice of Approval: September 24, 2026

The original PMA (P060011) was approved on May 3, 2007, for the C-flex intraocular lens and the device is indicated for primary implantation for the visual correction of aphakia in adults in whom a cataractous lens has been removed by phacoemulsification. 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. In P060011/S014, the RayOne Aspheric was approved: the previously approved 600C Aspheric Intraocular Lens preloaded within the Rayner RayOne Injection system. Supplement P060011/S039 approved RayOne EMV Toric, indicated for the correction of aphakia and the treatment of astigmatism. The current supplement was submitted to include RayOne Galaxy and RayOne Galaxy Toric, modifications of previously approved intraocular lens (IOL) models.

# II. INDICATIONS FOR USE

RayOne Galaxy (Model RAO605G) is intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia, in adult patients in whom a cataractous lens has been removed.

The IOL mitigates the effects of presbyopia by providing improved intermediate and near visual acuity while maintaining comparable distance visual acuity to a monofocal IOL. RayOne Galaxy is intended for implantation in patients with less than 1.00 diopter of pre-existing corneal astigmatism. The RayOne injection system is used to fold and assist in inserting the IOL into the eye.

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RayOne Galaxy Toric (Model RAO615X) is intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia, in adult patients in whom a cataractous lens has been removed.

The IOL mitigates the effects of presbyopia by providing improved intermediate and near visual acuity while maintaining comparable distance visual acuity to a monofocal IOL.

In addition, RayOne Galaxy Toric is intended to provide reduction of residual refractive astigmatism in patients with corneal astigmatism greater than or equal to 1.03 diopter, up to 3.07 diopter. The RayOne injection system is used to fold and assist in inserting the IOL into the eye.

### III. CONTRAINDICATIONS

There are no known contraindications.

### IV. WARNINGS AND PRECAUTIONS

The warnings and precautions can be found in the RayOne Galaxy and RayOne Galaxy Toric labeling.

### V. DEVICE DESCRIPTION

The RayOne Galaxy is a multifocal (trifocal) IOL.

The Galaxy IOL optic is designed to mitigate the effects of presbyopia by extending the range of vision from distance to near. The optic is biconvex and consists of a refractive spiral anterior optical surface and aspheric posterior surface, for the toric IOL the posterior surface is toric. The spiral optic extends from a radius of 0.55 mm to 1.6 mm and provides intermediate and near add powers of +1.5 D and +3.0 D, respectively, at the IOL plane.

The physical characteristics of RayOne Galaxy and RayOne Galaxy Toric are shown in TABLE 1.

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TABLE 1 RAYONE GALAXY AND RAYONE GALAXY TORIC PHYSICAL CHARACTERISTICS

|  Parameter | RayOne Galaxy | RayOne Galaxy Toric  |
| --- | --- | --- |
|  Lens image | ![img-0.jpeg](img-0.jpeg) | ![img-1.jpeg](img-1.jpeg)  |
|  Injector image | ![img-2.jpeg](img-2.jpeg)  |   |
|  Lens material | Rayacryl  |   |
|  Injector material | Polypropylene & TPE  |   |
|  Design features | Refractive spiral, multifocal, capsular bag fixated | Refractive spiral, toric, multifocal, capsular bag fixated  |
|  Injection system | Fully preloaded  |   |
|  Overall diameter (mm) | 12.5 ± 0.2  |   |
|  Optic diameter (mm) | 6.0 ± 0.1  |   |
|  Limb width (mm) | 0.38 ± 0.1  |   |
|  Limb thickness (mm) | 0.41 ± 0.15  |   |
|  Haptic style | Closed C-loop  |   |
|  Square edge | 360° posterior Enhanced Square Edge  |   |
|  Power range (increments) | +5.0 to +30.0 D (0.5 D) | N/A  |
|  Spherical equivalence (increments) | N/A | +6.0 to +30.0 D (0.5 D)  |
|  Cylinder power range (increments) | N/A | +1.5 to 3.75 D (0.75 D)  |
|  Index of refraction | 1.46  |   |

RayOne Galaxy Toric is available from:

• SE: +6.0 D to +30.0 D in 0.5 D increments
• Cylinder: +1.5 D to +3.75 D in 0.75 D increments

The effective corneal powers for each of the test lens plane cylindrical powers of the Galaxy Toric IOLs are shown in TABLE 2.

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TABLE 2 CYLINDER POWER AND CORNEAL ASTIGMATISM CORRECTION RANGE

|  IOL Type | IOL Power at IOL Plane (D) | Cyl Power on Corneal Plane (D) | Specified Range (D) Lower | Specified Range (D) Upper  |
| --- | --- | --- | --- | --- |
|  T3 | 1.5 | 1.03 | 1.03 | 1.53  |
|  T4 | 2.25 | 1.54 | 1.54 | 2.04  |
|  T5 | 3 | 2.05 | 2.05 | 2.56  |
|  T6 | 3.75 | 2.57 | 2.57 | 3.07  |

This medical device product has functions subject to FDA premarket review

## VI. ALTERNATIVE PRACTICES AND PROCEDURES

There are several other alternatives for the correction of restoring functional vision of the aphakic eye. Non-surgical options include special cataract glasses or contact lenses. Surgical options such as monofocal, simultaneous vision (e.g., multifocal, extended depth of focus, full visual range) 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.

## VII. MARKETING HISTORY

RayOne Galaxy and RayOne Galaxy Toric have not been marketed in the United States. These products have been available in the European Union since receiving CE Mark in July 2024. Since launch, there have been no recalls of RayOne Galaxy and RayOne Galaxy Toric (Models RAO605G and RAO615X). Additionally, there are no countries where the devices have been removed from the market for any reason(s) related to the safety or effectiveness of the device.

## 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:

- Secondary glaucoma
- IOL replacement or extraction
- Precipitates
- Reduced vision
- Vitreous herniation
- Excessive intraoperative vitreous loss
- IOL decentration
- Secondary membrane
- Expulsive hemorrhage
- IOL dislocation and subluxation
- Retrolenticular membrane

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- Corneal edema
- Endophthalmitis and panophthalmitis
- Retinal detachment
- Corneal dystrophy
- Hemorrhage
- Iris atrophy
- Pupillary block
- Cystoid macular edema
- Severe ametropia and aniseikonia
- Iridocyclitis and hyalitis
- Deviation from target refraction
- Fibrin reaction
- Elevated IOP
- Best-corrected visual acuity loss of 2 lines (10 letters) or more on the ETDRS chart measured at 3-4 months or later from any prior post-operative visit
- Anterior chamber cells grade 0.5 or greater at 7-14 days or later
- Posterior vitreous detachment
- Subconjunctival hemorrhage
- Anterior chamber cells greater than grade 2 at Day 1-2
- Keratoconjunctivitis sicca or worsening, not specified as Sjogren's
- Double/multiple images
- Meibomian gland dysfunction
- Progression of diabetic retinopathy

Secondary surgical interventions include, but are not limited to, lens repositioning, lens replacement, vitreous aspiration or iridectomy for pupillary block, wound leak repair, Posterior capsule opacification requiring Nd:YAG capsulotomy, capsular support device, pars plana vitrectomy and retinal detachment repair.

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

### IX. SUMMARY OF NON-CLINICAL STUDIES

RayOne Galaxy and RayOne Galaxy Toric (Models RAO605G and RAO615X) are composed of identical materials to the currently approved family of hydrophilic Rayacryl intraocular lenses (P060011). Preclinical studies were performed on the material parent device (P060011) instead of the final proposed device. These tests are as follows: physicochemical and biocompatibility testing, sterilization, packaging, shelf-life, and transport stability testing.

#### Physicochemical Testing

The results of physicochemical testing are shown in TABLE 3.

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TABLE 3 PHYSICOCHEMICAL TESTING

|  Test | Purpose | Acceptance Criteria | Results  |
| --- | --- | --- | --- |
|  ISO 11979-5 Exhaustive Extraction | Soxhlet extraction to recover polymerization residuals, impurities, and additives, quantitative analysis of extracts | No prespecified acceptance criteria. The results shall be evaluated to assess the risk for potentially harmful effects due to extractable components. | Acceptable Outcome  |
|  ISO 11979-5 Leachable study | The IOL material was extracted at 35°C for 72 h with water and hexane, respectively. The extracts were analyzed for potential leachables. | No prespecified acceptable criteria The results shall be evaluated to assess the risk for potentially harmful effects due to leachable components. | Acceptable Outcome  |
|  ISO 11979-5 Test for Hydrolytic Stability | Test to verify material does not degrade by hydrolysis | Hydrolytic stability of IOLs by investigation of dioptric power, recording of transmission spectra, light microscopic inspection and scanning electron microscopic (SEM) inspection. The exposure medium shall be qualitatively and quantitatively analyzed for any chemical entities at the end of the exposure period. | Pass  |
|  ISO 11979-5 Photostability test | Exposure to UV radiation in a saline solution using a radiation source (Xenon arc lamp) in order to simulate an in vivo exposure time of 20 years to evaluate the photostability. | The investigated lens material is stable against ultraviolet/visible light exposure. No significant change shall be detected between the physical appearance, UV/Vis spectra, dioptric power and image quality of the test material exposed to UV radiation and controls receiving no radiation. The exposure medium shall be qualitatively and quantitatively analyzed for any chemical entities after irradiation and compared to non-irradiated controls. | Pass  |

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|  Test | Purpose | Acceptance Criteria | Results  |
| --- | --- | --- | --- |
|  ISO 11979-5 Nd-YAG laser exposure test | To confirm IOL sample's stability when exposed to Nd:YAG lasers, and leakage of cytotoxic compounds. | No significant difference in physical appearance, spectral transmittance, or dioptric power after the exposure. No cytotoxic substances after laser exposure were detected. The exposure medium shall be qualitatively and quantitatively analyzed for any chemical entities after laser exposure. | Pass  |
|  ISO 11979-5 Evaluation of insoluble inorganics | To assess the IOL material for the presence of residual insoluble inorganics on and in the lens arising from manufacturing materials and process aids. | NO prespecified acceptance criteria. Quantitative determination of the inorganic ions presents in the test material. | Acceptable Outcome  |

## Biocompatibility Testing

RayOne Galaxy and RayOne Galaxy Toric (Models RAO605G and RAO615X) are made of the same material that was used with previously approved hydrophilic Rayacryl intraocular lenses (P060011). Biocompatibility testing (TABLE 4) was performed to support P060011 in accordance with all relevant ISO Standards (ISO 11979-5 and ISO 10993-1), 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 biocompatibility were conducted in accordance with provisions of 21 CFR 58, Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies.

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TABLE 4 BIOCOMPATIBILITY TESTING OF THE LENSES

|  Test | Purpose | Acceptance Criteria | Result  |
| --- | --- | --- | --- |
|  **Intraocular Lens***  |   |   |   |
|  Cytotoxicity - MEM elution (ISO 10993-5, ISO 11979-5) | To evaluate the potential for cellular toxicity. | Non-cytotoxic | Pass  |
|  Cytotoxicity - Inhibition of Cell Growth Test (ISO 10993-5) | To evaluate the potential for cellular toxicity. | Non-cytotoxic | Pass  |
|  Cytotoxicity – Agarose Overlay (ISO 10993-5, ISO 11979-5) | To evaluate the potential for cellular toxicity. | Non-cytotoxic | Pass  |
|  Sensitization - Guinea Pig Maximization (ISO 10993-10, ISO 11979-5) | To assess dermal contact sensitization in guinea pig at 24 and 48 hours after patch removal. | Non-sensitizer | Pass  |
|  Sensitization - Magnusson-Kligman Maximization Test (ISO 10993-11) | To investigate delayed contact hypersensitivity of the IOL in guinea pigs. | Non-sensitizer | Pass  |
|  Ocular Irritation Study in Rabbits (ISO 10993-10) | To evaluate the potential for ocular reactions at 1, 24, 48 and 72 hours after the single exposure in rabbits. | Non-irritant | Pass  |
|  Acute Toxicity (Limit-Test) (ISO 10993-11) | To evaluate the potential for acute toxicity in rats. | Non-toxic | Pass  |
|  Genotoxicity - Mouse Peripheral Blood Micronucleus Study (ISO 10993-3, ISO 11979-5) | To evaluate the potential to produce cytogenetic damage, resulting in micronuclei formation. | No micronuclei formation | Pass  |
|  Genotoxicity - In vitro chromosome aberration test (ISO 10993-3, ISO 11979-5) | To determine genotoxic potential in Chinese hamster ovary. | Non-genotoxic | Pass  |
|  Genotoxicity - Mouse Lymphoma Assay (ISO 10993-3, ISO 11979-5) | To detect potential gene mutations or chromosomal damage. | Non-genotoxic | Pass  |
|  Genotoxicity – Mutagenic activity (ISO 10993-3, ISO 11979-5) | To evaluate mutagenic activity. | Non-mutagenic | Pass  |

* In vivo ‘Test for Local Effects’ (non-ocular) and ‘Ocular Implantation’ test is deemed unnecessary for RayOne Family of hydrophilic IOL devices, considering that they are manufactured from a raw

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material with extensive historical clinical use. (Based on the recommendations of ISO 10993-1; and as per ISO 11979-5:2020, the risks arising from the use of the material are deemed acceptable based on the information from previous clinical use and other relevant literature.)

Biocompatibility testing (TABLE 5) was performed on the patient-contacting components of the RayOne injection system.

TABLE 5 BIOCOMPATIBILITY TESTING OF RAYONE INJECTION SYSTEM

|  Test | Purpose | Acceptance Criteria | Result  |
| --- | --- | --- | --- |
|  Cytotoxicity - Growth Inhibition Test in L929 Mouse Fibroblasts (Elution Test) (ISO 10993-5) | To evaluate the potential for cytotoxic effects using an in vitro mammalian cell culture test. | Non-cytotoxic | Pass  |
|  Systemic Toxicity – Acute Systemic Toxicity (in Swiss Albino Mice) (ISO 10993-11) | To evaluate toxic characteristics. | Non-toxic | Pass  |
|  Sensitization - Guinea Pig Maximization Sensitization Test (ISO 10993-10) | To evaluate the potential for sensitization. | Non-sensitizer | Pass  |
|  Sensitization - Test for delayed-type hypersensitivity (Guinea Pig Maximization Test) (ISO 10993-10) | To evaluate the potential for sensitization. | Non-sensitizer | Pass  |
|  Intracutaneous Reactivity Testing in Rabbits (ISO 10993-10) | To evaluate the potential for irritation. | Non-irritant | Pass  |
|  Intraocular Irritation Study in Rabbits (ISO 10993-10) | To evaluate the potential for irritation. | Non-irritant | Pass  |

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## Optical and Mechanical Testing

The optical properties of the Models 605G and 615X were tested per “ISO 11979-2: Ophthalmic implants – Intraocular lenses: Optical properties and test methods” and “ANSI Z80.30: Toric intraocular lenses.” The mechanical properties were tested per “ISO 11979-3: Ophthalmic implants – Intraocular lenses: mechanical properties and test methods.” In cases where the mechanical properties were related to the Rayacryl® material and overall IOL design (e.g. haptic design, optic body diameter), the testing is being leveraged from the parent device, Model 600C, for Models 605G and 615X, since these IOL models are manufactured from the same Rayacryl® material and are identical in non-optical design features (i.e. only differ by anterior and posterior optical surface design).

Testing was performed on lenses representing the low, the medium and the high diopter ranges:

RayOne Galaxy (Model RAO605G): power= +5.00 D, +20.00 D, +30.00 D

RayOne Galaxy Toric (Model RAO615X): spherical equivalent power (SE) = +6.0 D with cylinder = 0.75 D; SE = +20.0 D with cylinder = 0.75 D; SE = +30.0 D with cylinder = 0.75; SE = + 6.0 with cylinder 4.50; SE = + 20.0 with cylinder 4.50 D and SE = + 30.0 D with cylinder = 4.50 D.

The results of the testing demonstrate that the models 605G and 615X meet all of the ISO and ANSI standards for optical and mechanical properties, as summarized in TABLE 6, TABLE 7 and TABLE 8.

The figures showing the through-focus MTF at different apertures are available below. Please see Figure 1, Figure 2 and Figure 3 for RayOne Galaxy; and Figure 4, Figure 5, Figure 6, Figure 7, Figure 8, and Figure 9 for RayOne Galaxy Toric.

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TABLE 6 SUMMARY OF OPTICAL TESTING FOR RAYONE GALAXY – ISO 11979-2 & ANSI Z80.30

|  Test | Purpose | Acceptance Criteria | Results  |
| --- | --- | --- | --- |
|  BS EN ISO 11979-2 Clauses 4.2.1 and 4.2.3 - Dioptric power for simultaneous vision IOL (SVIOL) | To assess conformance to optical power tolerances (post injection*) | +10.0 ≤ SE ≤ +15.0 D: ± 0.3 D +15.0 < SE ≤ +25.0 D: ± 0.4 D | Passed  |
|  BS EN ISO 11979-2 Clause 4.3.4 - Determination of imaging quality - Multifocal IOL (MIOL) | To assess conformance to image quality tolerances (post injection*) | MTF measurement > 70% of the maximum theoretical MTF | Passed  |
|  BS EN ISO 11979-2 Spectral transmittance | To characterize the spectral transmission in the range 300 nm to 1100 nm, and the 10% cutoff wavelength | ≥380nm | Passed  |

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TABLE 7 SUMMARY OF OPTICAL TESTING FOR RAYONE GALAXY TORIC – ISO 11979-2 & ANSI Z80.30

|  Test | Purpose | Acceptance Criteria | Results  |
| --- | --- | --- | --- |
|  BS EN ISO 11979-2 Clauses 4.2.2 - Dioptric power for toric IOL (TIOL) – Average Power (SE) 4.2.2 - Dioptric power for toric IOL (TIOL) – Cylinder (C) Power | To assess conformance to optical power tolerances (post injection*) | +10.0 ≤ SE ≤ +15.0 D: ± 0.3 D +15.0 < SE ≤ +25.0 D: ± 0.4 D SE < 25 D and 0 < C ≤ 2.5 :±0.3 ±0,4 D SE < 25 D and 2.5 < C ≤ 4,5: ±0.4 D | Passed  |
|  BS EN ISO 11979-2 Clause 4.3.3 - Determination of imaging quality - Toric IOL (TIOL) 4.3.4 - Determination of imaging quality - Multifocal IOL (MIOL) | To assess conformance to image quality tolerances (post injection*) | MTF measurement ≥ 70% of the maximum theoretical MTF | Passed  |
|  BS EN ISO 11979-2 Clause 4.2.2 – Axis marks for toric IOL (TIOL) | To determine axis marks align with the meridian of lowest dioptric power. | ≤ 5° | Passed  |
|  BS EN ISO 11979-2 Spectral transmittance | To characterize the spectral transmission in the range 300 nm to 1100 nm, and the 10% cutoff wavelength | ≥380nm | Passed  |

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TABLE 8 SUMMARY OF MECHANICAL TESTING FOR RAYONE GALAXY AND RAYONE GALAXY TORIC – ISO 11979-3

|  Mechanical Test | Purpose | Acceptance Criteria | Results  |
| --- | --- | --- | --- |
|  BS EN ISO 11979-3:2012 Item 4.2 Clear optic diameter measurement | To verify the diameter of the clear optic zone to ensure it meets design specifications | ± 0.15 mm Min 4.25 mm | Passed  |
|  BS EN ISO 11979-3:2012 Item 4.2 Vault height measurement | To assess the distance between the IOL optic and the crystalline lens/ocular structures to verify appropriate vaulting and positioning | ± 0.25 mm 100% Pass | Passed  |
|  BS EN ISO 11979-3:2012 Item 4.11 IOL haptic pull test | To assess the force required to separate the haptic from the optic | No Broken Haptic 100% Pass | Passed  |
|  BS EN ISO 11979-3:2012 Clause 4.4 Compression force | To characterize the mechanical force exerted by the IOL haptics under compression initially | BS EN ISO 11979-3:2012: Measure and Report | Passed  |
|  BS EN ISO 11979-3:2012 Clause 4.5 Axial displacement in compression | To characterize the axial displacement of the IOL under compression | BS EN ISO 11979-3:2012: Measure and Report | Passed  |
|  BS EN ISO 11979-3:2012 Clause 4.6 Optic Decentration | To assess optic decentration under compression | (X̄ + 2σ) < 10% Clear Optic Diameter | Passed  |
|  BS EN ISO 11979-3:2012 Clause 4.7 Optic Tilt | To assess optic tilt under compression | (X̄ + 2σ) < 5° | Passed  |
|  BS EN ISO 11979-3:2012 Clause 4.8 Angle of Contact** | To characterize angle of contact of haptics under compression | Measure and Report | Passed  |

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|  Mechanical Test | Purpose | Acceptance Criteria | Results  |
| --- | --- | --- | --- |
|  BS EN ISO 11979-3:2012 Item 4.2 Clear optic diameter measurement | To verify the diameter of the clear optic zone to ensure it meets design specifications | ± 0.15 mm Min 4.25 mm | Passed  |
|  BS EN ISO 11979-3:2012 Item 4.2 Vault height measurement | To assess the distance between the IOL optic and the crystalline lens/ocular structures to verify appropriate vaulting and positioning | ± 0.25 mm 100% Pass | Passed  |
|  BS EN ISO 11979-3:2012 Item 4.11 IOL haptic pull test | To assess the force required to separate the haptic from the optic | No Broken Haptic 100% Pass | Passed  |
|  BS EN ISO 11979-3:2012 Clause 4.9 Compression Force Decay** | To characterize the mechanical force exerted by the IOL haptics under compression after 24 hours | Measure and Report | Passed  |
|  BS EN ISO 11979-3:2012 Clause 4.10 Dynamic Fatigue Durability** | To assess the capability of the haptics to cyclic compressive displacement | Withstand 250,000 cycles without damage | Passed  |
|  BS EN ISO 11979-3:2012 Clause 4.11 Surgical Manipulation | To assess the force required to separate the haptic from the IOL body | Force >0.25N | Passed  |
|  BS EN ISO 11979-3:2012 Clauses 4.12 and 5(a) Surface and Bulk Homogeneity * IOL injections of the pre-loaded IOL through RayOne injector performed with OphteisBio 3.0%, a sodium hyaluronate OVD. | To ensure the IOL is free of surface and bulk defects | The IOL shall be essentially free from defects | Passed  |
|  BS EN ISO 11979-3:2012 Clause 5 (b) Overall Diameter and Sagitta | To assess conformance to dimensional tolerances | Overall Diameter ±0.20 mm Sagitta ± 0.35 mm | Passed  |

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*Each lens is optically tested and inspected for Surface and Bulk Homogeneity prior to packaging and loading into the delivery system as part of standard manufacturing quality control. These measurements confirm compliance with ISO 11979-2 requirements for Dioptric Power and Imaging Quality, and compliance with ISO 11979-3 requirements for Surface and bulk Homogeneity Pre-Injection. Post-injection testing was performed to confirm compliance with ISO 11979-2 and ISO 11979-3 requirements, to verify the integrity of the delivery system and ensure clinical performance.

** Compression Force Decay, Angle of Contact, Dynamic Fatigue Durability testing was carried out as part of the design verification of parent IOL model RAO600C.

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FIGURE 1 +5.0 D RAO605G BATCH. FAR, INTERMEDIATE, AND NEAR ON-AXIS TF-MTF RESPONSE AT 50 LP/MM, FOR 2.0 MM (TOP), 3.0 MM (MIDDLE) AND 4.5 MM (BOTTOM) APERTURE SIZES

![img-3.jpeg](img-3.jpeg)

![img-4.jpeg](img-4.jpeg)

![img-5.jpeg](img-5.jpeg)

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FIGURE 2 +20.0 D RAO605G BATCH. FAR, INTERMEDIATE, AND NEAR ON-AXIS TF-MTF RESPONSE AT 50 LP/MM, FOR 2.0 MM (TOP), 3.0 MM (MIDDLE) AND 4.5 MM (BOTTOM) APERTURE SIZES

![img-6.jpeg](img-6.jpeg)

![img-7.jpeg](img-7.jpeg)

![img-8.jpeg](img-8.jpeg)

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FIGURE 3 +30.0 D RAO605G BATCH. FAR, INTERMEDIATE, AND NEAR ON-AXIS TF-MTF RESPONSE AT 50 LP/MM, FOR 2.0 MM (TOP), 3.0 MM (MIDDLE) AND 4.5 MM (BOTTOM) APERTURE SIZES

![img-9.jpeg](img-9.jpeg)

![img-10.jpeg](img-10.jpeg)

![img-11.jpeg](img-11.jpeg)

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FIGURE 4 +6.0D SE +0.75D CVL RAO615X BATCH. ON-AXIS TF-MTF RESPONSE AT 50 LP/MM, FOR 2.0 MM (TOP), 3.0 MM (MIDDLE) AND 4.5 MM (BOTTOM) APERTURE SIZES. TANGENTIAL DATA (BLUE LINE) IS THE LOW-POWER MERIDIAN AND SAGITTAL DATA (DOTTED-RED LINE) IS THE HIGH-POWER MERIDIAN

![img-12.jpeg](img-12.jpeg)

![img-13.jpeg](img-13.jpeg)

![img-14.jpeg](img-14.jpeg)

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FIGURE 5 +6.0D SE +4.50D CVL RA0615X BATCH. ON-AXIS TF-MTF RESPONSE AT 50 LP/MM, FOR 2.0 MM (TOP), 3.0 MM (MIDDLE) AND 4.5 MM (BOTTOM) APERTURE SIZES. TANGENTIAL DATA (BLUE LINE) IS THE LOW-POWER MERIDIAN AND SAGITTAL DATA (DOTTED-RED LINE) IS THE HIGH-POWER MERIDIAN

![img-15.jpeg](img-15.jpeg)

![img-16.jpeg](img-16.jpeg)

![img-17.jpeg](img-17.jpeg)

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FIGURE 6 +20.0D SE +0.75D CVL RAO615X BATCH. ON-AXIS TF-MTF RESPONSE AT 50 LP/MM, FOR 2.0 MM (TOP), 3.0 MM (MIDDLE) AND 4.5 MM (BOTTOM) APERTURE SIZES. TANGENTIAL DATA (BLUE LINE) IS THE LOW-POWER MERIDIAN AND SAGITTAL DATA (DOTTED-RED LINE) IS THE HIGH-POWER MERIDIAN

![img-18.jpeg](img-18.jpeg)

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FIGURE 7 +20.0D SE +4.50D CVL RAO615X BATCH. ON-AXIS TF-MTF RESPONSE AT 50 LP/MM, FOR 2.0 MM (TOP), 3.0 MM (MIDDLE) AND 4.5 MM (BOTTOM) APERTURE SIZES. TANGENTIAL DATA (BLUE LINE) IS THE LOW-POWER MERIDIAN AND SAGITTAL DATA (DOTTED-RED LINE) IS THE HIGH-POWER MERIDIAN

![img-19.jpeg](img-19.jpeg)

![img-20.jpeg](img-20.jpeg)

![img-21.jpeg](img-21.jpeg)

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FIGURE 8 +30.0D SE +0.75D CVL RAO615X BATCH. ON-AXIS TF-MTF RESPONSE AT 50 LP/MM, FOR 2.0 MM (TOP), 3.0 MM (MIDDLE) AND 4.5 MM (BOTTOM) APERTURE SIZES. TANGENTIAL DATA (BLUE LINE) IS THE LOW-POWER MERIDIAN AND SAGITTAL DATA (DOTTED-RED LINE) IS THE HIGH-POWER MERIDIAN

![img-22.jpeg](img-22.jpeg)

![img-23.jpeg](img-23.jpeg)

![img-24.jpeg](img-24.jpeg)

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FIGURE 9 +30.0D SE +4.50D CVL RA0615X BATCH. ON-AXIS TF-MTF RESPONSE AT 50 LP/MM, FOR 2.0 MM (TOP), 3.0 MM (MIDDLE) AND 4.5 MM (BOTTOM) APERTURE SIZES. TANGENTIAL DATA (BLUE LINE) IS THE LOW-POWER MERIDIAN AND SAGITTAL DATA (DOTTED-RED LINE) IS THE HIGH-POWER MERIDIAN

![img-25.jpeg](img-25.jpeg)

## Injector Validation

Injector validation was conducted as part of the mechanical and optical testing of the Galaxy, including the visual inspection of the IOL and injector pre-and post-injection. The test results summarized above reflect the compatibility of the RayOne injector and Galaxy IOL.

The testing demonstrated that the Galaxy IOL can be successfully delivered across the entire range of IOLs using OphteisBio 3.0% viscoelastics.

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## Sterilization and Shelf-Life Evaluation

The RayOne Galaxy and RayOne Galaxy Toric are sterilized by moist heat. Sterilization evaluation, shelf-life and transport stability testing, and bacterial endotoxin testing were performed to support the RayOne Galaxy and RayOne Galaxy Toric. The results are summarized in TABLE 9.

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TABLE 9 STERILIZATION AND SHELF-LIFE TESTING

|  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 1.0E-6, based upon inactivation of control biological indicators (BIs, G. stearothermophilus) in process challenge devices (PCDs). Validated process parameters will be used for parametric release upon confirmation that Independent Recorder and controller meet batch release requirements. | 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 ≤ 1.0E-6. | Passed  |
|  Transport stability (ISO 11979-6, ISO 11607-1, ASTM F1886, ASTM D4991, ASTM F1929, ASTM F88, & ASTM F1140) | Confirm that both the inner tray and outer pouch sterile barrier packaging can maintain device sterility throughout anticipated transport conditions. Testing includes visual inspection, whole package integrity (dye immersion – weight change, validated alternative method) and seal integrity assessments (seal peel and dye penetration testing for inner tray; burst test and dye penetration for outer pouch) after transport conditioning. | 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 dye immersion, - weight change, there is no reduction in weight of the inner tray after it is held under vacuum for 30 minutes in vacuum chamber. For seal peel strength, average peel strength exceeds minimum force. For burst test, internal pressure exceeds minimum burst pressure before package failure. For dye penetration, no penetration of dye into seal area is observed. | Passed  |

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|  Test | Purpose | Acceptance Criteria | Results  |
| --- | --- | --- | --- |
|  Shelf-life (ISO 11979-6, ISO 11607-1, ASTM F1886, ASTM D4991, ASTM F1929, ASTM F88, & ASTM F1140) | Confirm that both the inner tray and outer pouch sterile barrier packaging can maintain device sterility throughout claimed shelf life. Testing includes visual inspection, whole package integrity (dye immersion– weight change, validated alternative method) and seal integrity assessments (seal peel and dye penetration testing for inner tray; burst test and dye penetration for outer pouch) 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 dye immersion, - weight change, there is no reduction in weight of the inner tray after it is held under vacuum for 30 minutes in vacuum chamber. For seal peel strength, average peel strength exceeds minimum force. For burst test, internal pressure exceeds minimum burst pressure before package failure. For dye penetration, no penetration of dye into seal area is observed. | Passed  |
|  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 | Passed  |
|  Bioburden Estimation Testing (ISO 11737-1) | Confirm that naturally occurring Bioburden is controlled on product and in manufacturing environment. | Less than the Specification Limit of < 100 Colony Forming Units (CFU)/device | Passed  |

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# X. SUMMARY OF PRIMARY CLINICAL STUDIES

The applicant performed a clinical study to establish a reasonable assurance of safety and effectiveness of implantation with the RayOne Galaxy (Model RAO605G) multifocal intraocular lens for the visual correction of aphakia in adults in whom a cataractous lens has been removed by phacoemulsification extraction in the US under IDE # G210105. Data from this clinical study were the basis for the PMA approval decision.

Clinical studies have been conducted on the C-flex 570C IOL (G020115), RayOne EMV Toric (G230072) and RayOne Galaxy (G210105). RayOne EMV Toric is a combination of the optical design of the C-flex and RayOne EMV parent lenses. RayOne Galaxy Toric is a combination of the optical design of RayOne Galaxy (anterior surface) and RayOne EMV Toric (posterior surface) and was approved under P060011/S039. Clinical data from the RayOne EMV Toric was leveraged for approval of the RayOne Galaxy Toric (Model RAO615X), therefore clinical data presented in the labeling of the RayOne Galaxy Toric is not incorporated into this SSED.

Summaries of these clinical studies are presented below.

# Clinical Data on C-flex

The Rayner C-flex 570C intraocular lens study was a multi-center IDE clinical trial (G020115), with a historical control designed to assess safety and effectiveness. Three hundred and one (301) C-flex subjects were enrolled (unilateral implants) in this investigation. Additionally, data from one hundred and eighty-two (182) model Centerflex IOL subjects was used as supportive data. The Centerflex IOL is identical to the C-flex model in all aspects except that the C-flex additionally features an Enhanced Square Edge. This feature is a 360° raised ridge encircling the periphery of both the anterior and posterior surfaces of the optic body (including the optic-haptic junction). The Rayner C-flex IOL met or exceeded historical controls for posterior chamber IOLs in all areas, for best corrected visual acuity at the 12 months post-operative examination. Safety was evaluated regarding specific cumulative adverse event rates and persistent adverse events rates as specified in ISO 11979-7. Primary safety analyses were based on data from all enrolled procedures with follow-up to at least one-year post implantation. The pooled C-flex and Centerflex cumulative and persistent adverse event rates at 12-months were lower than the FDA historical control grid in all areas except persistent macular edema, persistent corneal edema and cumulative pupillary block. These rates were higher than the grid rate, but the differences were not statistically significant. The results achieved by 283 patients in the C-flex 570C study and 166 patients in the Centerflex IOL study followed for one year, provide the basis for the data which were used to support that the EMV IOL (200E) design can be used for the visual correction of aphakia. Clinical studies were not conducted with the EMV IOL (200E) to assess the effect of its aspheric surface or increased optic size and overall diameter on spherical aberration, visual acuity or contrast sensitivity.

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# Clinical Data on RayOne EMV Toric RAO210T

The US IDE clinical study to establish a reasonable assurance of safety and effectiveness of implantation with the RayOne EMV Toric IOL for visual correction of aphakia and corneal astigmatism following removal of a cataractous lens in the US under IDE # G230072. The study data support a significant dioptric reduction in refractive cylinder and reduction in absolute cylinder, rotational stability of the lens, and UDVA following implantation of the RayOne EMV Toric IOL. RayOne EMV Toric received marketing approval from the Agency on October 9, 2025, under Panel Track Supplement, P060011/S039.

The clinical study that supported the marketing approval of the RayOne EMV Toric (Model RAO210T) established the safety profile of the toric device. The toric feature of the RayOne EMV Toric IOL (Model RAO210T) is incorporated into the posterior surface of the RayOne Galaxy Toric (Model RAO615X) IOL, which also includes on its anterior surface, the optical design of the RayOne Galaxy (Model RAO605G) IOL.

The summary of the RayOne Galaxy (Model RAO605G) IOL clinical study is presented below. Based on the results of the RayOne Galaxy (Model RAO605G) study and the above-mentioned RayOne EMV Toric (Model RAO210T) study, no additional clinical data were required to support the safety and effectiveness of the RayOne Galaxy Toric (Model RAO615X).

In addition, the material used to manufacture the RayOne Galaxy Toric (Model RAO615X) was approved by the U.S. Food and Drug Administration under PMA P060011 on May 3, 2007.

# Clinical Data on RayOne Galaxy RAO605G

## A. Study Design

Patients were treated between September 26, 2024 and April 18, 2025. The database for this Panel Track Supplement reflected data collected through September 2, 2025 and included 254 patients. There were 10 investigational sites.

The study was a prospective, multicenter, randomized, active-controlled, masked, pivotal clinical study based on ISO 11979-7:2024.

The control group was the RayOne Aspheric (Model RAO600C) monofocal IOL, a legally marketed alternative with similar indications for use.

The study compared the RayOne Galaxy (Model RAO605G) multifocal IOL (investigational device) with the RayOne Aspheric (Model RAO600C) monofocal IOL (control device) following approximately 6 months (120 to 180 days) of post-operative assessment.

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Patients who signed the informed consent form (ICF) were considered enrolled in the study and subsequently screened for eligibility. Inclusion and exclusion criteria were required to be applied prior to subject randomization. Patients who met all protocol-specified eligibility criteria were randomized to one of the two study arms to receive either the RayOne Galaxy Multifocal IOL (test) or the RayOne Aspheric Monofocal IOL (control) in both eyes. The first eye (A) which underwent cataract surgery and IOL implantation was the eye with worse pre-operative best corrected distance visual acuity (BCDVA). If pre-operative BCDVA was the same for each eye, the right eye was selected as the first eye. Patients underwent cataract surgery and IOL implantation in the second eye (B) 7 to 30 days following surgery on the first eye.

Patients and site personnel performing post-operative manifest refraction and visual acuity assessments, including defocus curve testing and contrast sensitivity, as well as personnel administering assessments of pupil size, patient-reported outcome measures, and non-directed assessment of visual symptoms, were masked to treatment assignment. Patients were also masked to their IOL assignment.

The clinical data source was the U.S. IDE clinical trial of the RayOne Galaxy (IDE G210105), which included 230 randomized Patients at 10 U.S. investigational sites.

The statistical analysis plan included protocol-specified safety and effectiveness performance criteria and comparative hypothesis testing. Primary effectiveness analyses were conducted using the Intent-to-Treat (ITT) Set, with First Implanted eyes serving as the primary eyes for analysis. The co-primary effectiveness endpoints were mean photopic monocular BCDVA at 4 meters (m) and photopic monocular distance corrected near visual acuity (DCNVA) at 40 cm in First Implanted eyes at 120 to 180 days post-operatively (Visit 4). The BCDVA endpoint was evaluated against a prespecified performance criterion, and the DCNVA endpoint compared the Multifocal and Monofocal groups using a one-sided t-test for superiority. Up to 288 patients were planned to be enrolled, with up to 230 patients randomized and at least 100 patients in each treatment group completing the 6-month follow-up. The sample size was based on the following assumptions (TABLE 10). Missing Visit 4 values for the primary effectiveness analyses were addressed using multiple imputation under a missing-at-random assumption.

TABLE 10 SAMPLE SIZE CALCULATIONS FOR EACH DISTANCE (4M, 66 CM AND 40CM)

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

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

Randomization was stratified by site, and 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.

# 1. Clinical Inclusion and Exclusion Criteria

Enrollment in the RayOne Galaxy clinical study was limited to patients who met the following inclusion criteria and none of the exclusion criteria. All inclusion and exclusion ocular criteria were required to be satisfied in both eyes:

Inclusion Criteria:

- Male or female, 22 years or older at the pre-operative visit
- Have bilateral cataracts with BCDVA of 0.30 logMAR or worse in each eye with or without a glare source and are eligible for phacoemulsification cataract surgery in both eyes
- Be willing to undergo cataract surgery in the second eye 7 to 30 days after surgery in the first eye
- Subjects who are projected to have best corrected distance visual acuity 0.20 logMAR (20/30) or better after IOL implantation as determined by the medical judgment of the Investigator
- Clear intraocular media other than cataract
- Calculated IOL spherical equivalent power between +5.0 to +30.0 D in 0.50 D steps
- If a contact lens wearer, willing to discontinue wearing of rigid gas-permeable (RGP) contact lenses for ≥ 14 days or soft contact lenses (SCL) for ≥ 3 days prior to the pre-operative visit
- Contact lens wearers must demonstrate stability of keratometry. (For pre-operative keratometry recorded on two consecutive examination dates at least one week apart after lens discontinuation, the difference between two consecutive readings for vertical as well as horizontal are no more than 0.50 D, and changes in keratometric axes is no more than ±15°.)
- Available and willing to comply with examination procedures and study visits
- Have the capability to understand and sign an IRB approved informed consent form and privacy authorization in accordance with local regulations
- Female subjects must be postmenopausal, surgically sterilized, or, if of childbearing potential, have a negative urine pregnancy test at the Pre-operative Visit. Women of childbearing potential must use an acceptable form of contraception throughout 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.

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Patients were not permitted to enroll in the RayOne Galaxy clinical study if they met any of the following exclusion criteria:

# Exclusion Criteria:

- Previous intraocular, corneal, or retinal detachment surgery, including corneal transplant, LASIK / LASEK / PRK, SMILE, astigmatic keratotomy and limbal relaxing incisions (Note: pterygium excision was not exclusionary)
- Diagnosed degenerative visual disorders (e.g. macular degeneration, retinal detachment, proliferative diabetic retinopathy, or other retinal disorders) that are predicted to cause future acuity losses to a level of 0.20 logMAR (20/30) or worse
- Significant anterior segment pathology that might increase intraoperative risk or compromise IOL stability (e.g. pseudoexfoliation syndrome)
- Subjects with conditions associated with increased risk of zonular rupture that may affect post-operative centration or tilt of IOL
- Potentially occludable angle or ciliary body tumor, or other pathology that might increase risk to subject safety, based on gonioscopic observation
- Subjects reasonably expected to require secondary ocular surgical intervention or laser treatment (other than YAG capsulotomy)
- Subjects with clinically significant corneal pathology
- Subjects with traumatic, congenital, or complicated cataract
- Participating in a concurrent drug or device clinical trial or who have participated in a drug or device trial within 30 days of the pre-operative visit
- Subjects with any other serious ocular pathology (e.g. glaucoma, severe dry eye, history of intraocular inflammation, history of retinal surgery or retinal laser procedure) or underlying systemic medical condition (e.g., uncontrolled diabetes) or circumstance that, based on the Investigator's judgment, poses a concern for the subjects' safety or could confound the results of the study
- Use of medications known to interfere with visual performance, pupil dilation, or iris structure within 30 days of the pre-operative visit, at the discretion of the Investigator
- Pregnant or nursing females
- Subjects with pre-existing anterior keratometric corneal astigmatism of 1.00 D or greater in either eye (Note: corneal incisions intended to reduce astigmatism are not permitted)
- Irregular astigmatism in either eye

# 2. Follow-up Schedule

All patients were scheduled to return for follow-up examinations at Day 1 to 2, Day 7 to 14, and Day 30 to 60 following surgery in each eye, and Day 120 to 180 following surgery in the second implanted eye postoperatively. Cataract surgery and IOL implantation of the second eye were scheduled 7 to 30 days following surgery of the first eye.

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The full schedule of events is provided in TABLE 11. The study comprised 10 scheduled visits, as shown below:

1. Pre-operative Visit A/B – Form 00 (-90 to 0 days)
2. Operative Visit A – Form 0 (Day 0)
3. Visit 1A – Form 1 (1 to 2 days post-operative)
4. Visit 2A – Form 2 (7 to 14 days post-operative)
5. Visit 3A – Form 3 (30 to 60 days post-operative)
6. Operative Visit B – Form 0 (Day 0)
7. Visit 1B – Form 1 (1 to 2 days post-operative)
8. Visit 2B – Form 2 (7 to 14 days post-operative)
9. Visit 3B – Form 3 (30 to 60 days post-operative)
10. Visit 4 – Form 4 (120 to 180 days post-operative from second implanted eye)

Preoperatively, informed consent, demographics, concomitant medications, ocular and significant non-ocular medical history, urine pregnancy testing (if applicable), photopic pupil size, photopic monocular UCDVA at 4 meters, manifest refraction, photopic monocular BCDVA at 4 m, potential visual acuity, corneal topography, keratometry/biometry/target refraction/IOL power calculation, slit lamp biomicroscopy, intraocular pressure, gonioscopy, and dilated fundus examination were performed in relation to the index procedure. Visual acuity assessments were performed using the M&S Clinical Trial Suite (M&S Technologies, Niles, IL, USA) computerized test system, early treatment diabetic retinopathy study (ETDRS) visual acuity testing.

Postoperatively, the objective parameters measured during the study included uncorrected distance visual acuity (UCDVA), manifest refraction, BCDVA, uncorrected intermediate visual acuity (UCIVA), DCIVA, uncorrected near visual acuity (UCNVA), DCNVA, pupil size, intraocular pressure, slit lamp biomicroscopy, posterior capsule opacification (PCO) assessment, IOL observations, lens stability (decentration and tilt), and dilated fundus examination. Visual acuity assessments were also performed using the M&S Clinical Trial Suite computerized test system, ETDRS visual acuity testing. At Visit 4, additional assessments included monocular and binocular visual acuity assessments, monocular and binocular best distance corrected defocus curves, monocular best corrected contrast sensitivity under mesopic without glare, mesopic with glare, and photopic with glare conditions, and patient reported outcome questionnaires. Contrast sensitivity was assessed monocularly using the M&S System with sin-wave gratings at 1.5, 3, 6, 12 and/or 189 cycles per degree (CPD) at a test distance of 2.5m. Non-directed assessment of visual symptoms was performed at postoperative visits. The specific assessments and the visits at which they were performed are provided in TABLE 11. Adverse events and complications were recorded at all visits.

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TABLE 11 SCHEDULE OF EVENTS

|   | Both Eyes | First Implanted Eye (A)^{1} |   |   |   | Second Implanted Eye (B) |   |   |   | Both Eyes  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   |  Visit 00A/B Pre-Op | Visit 0A Operative | Visit 1A Post-Op | Visit 2A Post-Op | Visit 3A Post-Op | Visit 0B Operative^{2} | Visit 1B Post-Op | Visit 2B Post-Op | Visit 3B Post-Op | Visit 4 Post-Op  |
|  Procedure | D -90 –D 0 (V0A)^{3} | Day 0 | Day 1-2 | Day 7-14 | Day 30-60 | Day 0 | Day 1-2 | Day 7-14 | Day 30-60 | Day 120-180 from 2nd eye  |
|  Informed Consent/HIPAA | X |  |  |  |  |  |  |  |  |   |
|  Inclusion/Exclusion Criteria Review | X | X^{4} |  |  |  | X^{4} |  |  |  |   |
|  Demographics | X |  |  |  |  |  |  |  |  |   |
|  Ocular and Significant Non-ocular Medical History | X* | X |  |  |  | X |  |  |  |   |
|  Urine Pregnancy Test (if applicable) | X |  |  |  |  |  |  |  |  |   |
|  Potential Visual Acuity | X* |  |  |  |  |  |  |  |  |   |
|  Keratometry / Biometry / Target refraction / IOL power calculation | X* |  |  |  |  |  |  |  |  |   |
|  Corneal Topography | X* |  |  |  |  |  |  |  |  |   |
|  Gonioscopy | X* |  |  |  |  |  |  |  |  |   |
|  Randomization | X |  |  |  |  |  |  |  |  |   |
|  Operative Procedures |  | X |  |  |  | X |  |  |  |   |
|  Non-directed Assessment of Visual Symptoms^{5} |  |  | X | X | X |  | X | X | X | X  |
|  Patient Reported Outcome Questionnaires^{5,6} |  |  |  |  |  |  |  |  | X | X  |
|  Photopic Pupil size | X |  |  |  |  |  |  |  |  | X  |
|  Mesopic Pupil size^{5,7} |  |  |  |  | X |  |  |  | X | X  |
|  Manifest Refraction^{#} – 4 m^{5} | X |  |  | X | X |  |  | X | X | X  |

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|   | Both Eyes | First Implanted Eye (A)^{1} |   |   |   | Second Implanted Eye (B) |   |   |   | Both Eyes  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   |  Visit 00A/B Pre-Op | Visit 0A Operative | Visit 1A Post-Op | Visit 2A Post-Op | Visit 3A Post-Op | Visit 0B Operative^{2} | Visit 1B Post-Op | Visit 2B Post-Op | Visit 3B Post-Op | Visit 4 Post-Op  |
|  Procedure | D -90 –D 0 (V0A)^{3} | Day 0 | Day 1-2 | Day 7-14 | Day 30-60 | Day 0 | Day 1-2 | Day 7-14 | Day 30-60 | Day 120-180 from 2nd eye  |
|  UCDVA - Photopic, Monocular^{#} – 4 m^{5} | X |  | X | X | X |  | X | X | X | X  |
|  UCDVA - Photopic, Binocular^{#} – 4 m |  |  |  |  |  |  |  | X | X | X  |
|  BCDVA - Photopic, Monocular^{#} – 4 m^{5} | X |  |  | X | X |  |  | X | X | X  |
|  BCDVA - Photopic, Binocular^{#} – 4 m |  |  |  |  |  |  |  | X | X | X  |
|  BCDVA – Mesopic, Monocular^{#} – 4 m |  |  |  |  |  |  |  |  |  | X  |
|  BCDVA – Mesopic, Binocular^{#} – 4 m |  |  |  |  |  |  |  |  |  | X  |
|  UCNVA - Photopic Monocular^{#} – 40 cm |  |  |  |  | X |  |  |  | X | X  |
|  UCNVA - Photopic Binocular^{#} – 40 cm |  |  |  |  |  |  |  |  | X | X  |
|  DCNVA - Photopic Monocular^{#} – 40 cm |  |  |  |  | X |  |  |  | X | X  |
|  DCNVA - Photopic Binocular^{#} – 40 cm |  |  |  |  |  |  |  |  | X | X  |
|  DCNVA - Mesopic Monocular^{#} – 40 cm |  |  |  |  | X |  |  |  | X | X  |
|  DCNVA - Mesopic Binocular^{#} – 40 cm |  |  |  |  |  |  |  |  | X | X  |
|  BCNVA – Photopic Monocular^{#} – 40 cm |  |  |  |  |  |  |  |  |  | X  |
|  BCNVA – Photopic Binocular^{#} – 40 cm |  |  |  |  |  |  |  |  |  | X  |
|  UCIVA - Photopic Monocular^{#} – 66 cm |  |  |  |  | X |  |  |  | X | X  |
|  UCIVA - Photopic Binocular^{#} – 66 cm |  |  |  |  |  |  |  |  | X | X  |
|  DCIVA - Photopic Monocular^{#} – 66 cm |  |  |  |  | X |  |  |  | X | X  |
|  DCIVA - Photopic Binocular^{#} – 66 cm |  |  |  |  |  |  |  |  | X | X  |

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|   | Both Eyes | First Implanted Eye (A)^{1} |   |   |   | Second Implanted Eye (B) |   |   |   | Both Eyes  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   |  Visit 00A/B Pre-Op | Visit 0A Operative | Visit 1A Post-Op | Visit 2A Post-Op | Visit 3A Post-Op | Visit 0B Operative^{2} | Visit 1B Post-Op | Visit 2B Post-Op | Visit 3B Post-Op | Visit 4 Post-Op  |
|  Procedure | D -90 –D 0 (V0A)^{3} | Day 0 | Day 1-2 | Day 7-14 | Day 30-60 | Day 0 | Day 1-2 | Day 7-14 | Day 30-60 | Day 120-180 from 2nd eye  |
|  DCIVA - Mesopic Monocular^{#} – 66 cm |  |  |  |  | X |  |  |  | X | X  |
|  DCIVA - Mesopic Binocular^{#} – 66 cm |  |  |  |  |  |  |  |  | X | X  |
|  Monocular Best Distance Corrected Defocus Curves – 4 m (first implanted eyes) |  |  |  |  |  |  |  |  |  | X  |
|  Binocular Best Distance Corrected Defocus Curves – 4 m |  |  |  |  |  |  |  |  |  | X  |
|  Contrast Sensitivity - Monocular Best Corrected (Mesopic without glare) – 2.5 m (first implanted eyes) |  |  |  |  |  |  |  |  |  | X  |
|  Contrast Sensitivity - Monocular Best Corrected (Mesopic with glare) – 2.5 m (first implanted eyes) |  |  |  |  |  |  |  |  |  | X  |
|  Contrast Sensitivity - Monocular Best Corrected (Photopic with glare) – 2.5 m (first implanted eyes) |  |  |  |  |  |  |  |  |  | X  |
|  Intraocular Pressure^{5} | X* |  | X | X | X |  | X | X | X | X  |
|  Slit lamp Biomicroscopy^{5} | X* |  | X | X | X |  | X | X | X | X  |
|  Posterior Capsule Opacification (PCO) Assessment^{5} (dilated) |  |  | X | X | X |  | X | X | X | X  |
|  IOL Observations^{5} (dilated) |  |  | X | X | X |  | X | X | X | X  |

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|   | Both Eyes | First Implanted Eye (A)^{1} |   |   |   | Second Implanted Eye (B) |   |   |   | Both Eyes  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   |  Visit 00A/B Pre-Op | Visit 0A Operative | Visit 1A Post-Op | Visit 2A Post-Op | Visit 3A Post-Op | Visit 0B Operative^{2} | Visit 1B Post-Op | Visit 2B Post-Op | Visit 3B Post-Op | Visit 4 Post-Op  |
|  Procedure | D -90 –D 0 (V0A)^{3} | Day 0 | Day 1-2 | Day 7-14 | Day 30-60 | Day 0 | Day 1-2 | Day 7-14 | Day 30-60 | Day 120-180 from 2nd eye  |
|  Lens Stability - decentration and tilt (dilated)^{5} |  |  |  |  | X |  |  |  | X | X  |
|  Dilated Fundus Exam^{[5]} (including Fundus Visualization at follow-up) | X* |  |  |  | X |  |  |  | X | X  |
|  Adverse Events^{5} | X | X | X | X | X | X | X | X | X | X  |
|  Device Deficiencies^{5} |  | X | X | X | X | X | X | X | X | X  |
|  Concomitant Medications^{5} | X | X | X | X | X | X | X | X | X | X  |
|  Exit from Study |  |  |  |  |  |  |  |  |  | X  |

1. The first implanted eye (A) was the eye with the worse preoperative BCDVA. If BCDVA of both eyes is the same, the first implanted eye (A) was the right eye

2. Must occur 7-30 days after first eye (A) Operative Visit

3. Pre-operative window for both eyes is within 90 days of the Operative visit for the first implanted eye (Visit 0A)

4. Review of inclusion/exclusion criteria before surgery

5. To be completed at post-operative Unscheduled Visit (USV), as specified

6. To be completed at any USV after Visit 2B post-operative

7. To be assessed at any USV or after Visit 3, if subject complains of severe visual symptoms. (Note: mesopic pupil size is included in the assessments at scheduled visits of V3 and V4)

* Assessments performed as standard of care within the -90 – 0 pre-operative visit screening window may be used as qualifying assessments prior to date of informed consent.

[ ] Optional at USV, based on Investigator's discretion

# Visual acuity assessments performed using computerized ETDRS charts

Note: For study visits designated A or B, 'A' represents the first eye implanted (Eye A), and 'B' represents the second eye implanted (Eye B). Monocular assessments were performed at Visits 1 A/B, 2 A/B, and 3 A/B for only Eye A or only Eye B, respectively, unless binocular assessments are specified. At Visit 4, monocular assessments and binocular assessments were completed for both eyes, unless otherwise noted.

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

### 3. Clinical Endpoints

With regards to safety:

- *Primary Safety Endpoints*

○ Rates of device-related secondary surgical interventions related to the optical properties of the investigational device through 120 to 180 days post-operatively (Visit 4)
○ Rates of BCDVA of 0.30 logMAR or better at 120 to 180 days post-operatively (Visit 4) compared to the ISO Safety and Performance Endpoint (SPE) rates as described in ISO 11979-7 (2024)
○ Rates of IOL adverse events through 120 to 180 days post-operatively (Visit 4) compared to the ISO SPE rates as described in ISO 11979-7 (2024)
○ Rates of all other adverse events not included in IOL adverse events from ISO 11979-7 (2024) through 120 to 180 days post-operatively (Visit 4)
○ Rates of adverse events defined in Masket et al.¹ through 120 to 180 days post-operatively (Visit 4)

- *Secondary Safety Endpoint*

○ Frequency and proportion of subjects with visual disturbances reported as severe or most bothersome, collected via a Patient-Reported Outcomes (PRO) survey using the Quality of Vision (QoV) questionnaire and Patient Vision Questionnaire 120 to 180 days post-operatively (Visit 4)

- *Additional Safety Endpoints*

○ Mean monocular distance contrast sensitivity (mesopic without glare, mesopic with glare, photopic with glare) in first implanted eyes 120 to 180 days post-operatively (Visit 4)

○ BCDVA at 120 to 180 days post-operatively (Visit 4) stratified by:

▪ Age (< 65 and ≥ 65 years)
▪ Investigator

¹ Masket S, Rorer E, Stark W, Holladay JT, MacRae S, Tarver ME, Glasser A, Calogero D, Hilmantel G, Nguyen T, Eydelman M. Special Report: The American Academy of Ophthalmology Task Force Consensus Statement on Adverse Events with Intraocular Lenses. Ophthalmology. 2017 Jan;124(1):142-144. doi: 10.1016/j.ophtha.2016.09.031.

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Adverse Events

○ Rates and causes of loss of BCDVA of 0.20 logMAR or worse between one form evaluation and a second later form evaluation
○ Frequency and proportion of subjects with visual disturbances collected via a PRO survey using the QoV questionnaire and Patient Vision Questionnaire 120 to 180 days post-operatively (Visit 4)
○ Frequency and proportion of eyes with ocular/visual symptoms (non-directed complaints) collected via open-ended questions at 120 to 180 days (Visit 4)
○ Frequency and percentage of fundus visualization at 120 to 180 days post-operatively (Visit 4)

With regards to effectiveness:

• Primary Effectiveness Endpoints

○ Mean photopic monocular best corrected distance visual acuity (BCDVA) at 4 meters in First Implanted eyes (performance criterion: ≤ 0.20 logMAR) 120 to 180 days post-operatively (Visit 4)
○ Photopic monocular distance-corrected near visual acuity (DCNVA) at 40 cm in First Implanted eyes 120 to 180 days post-operatively (Visit 4)

• Secondary Effectiveness Endpoints

1. Photopic monocular BCDVA at 4 meters in First Implanted eyes 120 to 180 days post-operatively (Visit 4)
2. Photopic monocular distance-corrected intermediate visual acuity (DCIVA) at 66 cm in First Implanted eyes 120 to 180 days post-operatively (Visit 4)
3. Mean photopic monocular DCIVA at 66 cm in First Implanted eyes (performance criterion: ≤ 0.20 logMAR) 120 to 180 days postoperatively (Visit 4)
4. Mean photopic distance-corrected visual acuity (DCVA) in First Implanted eyes (performance criterion: ≤ 0.20 logMAR) 120 to 180 days postoperatively (Visit 4) at the following distances:

▪ 1.0 m
▪ 50 cm

5. Mean photopic monocular DCNVA at 40 cm in First Implanted eyes (performance criterion: ≤ 0.20 logMAR) 120 to 180 days postoperatively (Visit 4)

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6. Binocular best corrected distance defocus curves at 120 to 180 days post-operatively (Visit 4)

• Additional Effectiveness Endpoints

○ Photopic monocular logMAR BCDVA (4 m), DCIVA (66 cm), and DCNVA (40 cm) in first eyes implanted, second (“fellow”) eyes, and all eyes

○ Photopic monocular logMAR BCNVA (40 cm) in first eyes implanted, second (“fellow”) eyes, and all eyes

○ Mesopic monocular logMAR BCDVA (4m), DCIVA (66 cm) and DCNVA (40 cm) in first eyes implanted, second (“fellow”) eyes, and all eyes

○ Photopic binocular logMAR BCDVA (4 m), DCIVA (66 cm), and DCNVA (40 cm)

○ Photopic binocular logMAR BCNVA (40 cm)

○ Mesopic binocular logMAR BCDVA (4m), DCIVA (66 cm) and DCNVA (40 cm)

○ Mesopic monocular logMAR DCIVA (Multifocal (test) group) compared to mesopic monocular logMAR BCDVA (control group) in first implanted eyes, second (“fellow”) eyes, and all eyes

○ Mesopic monocular logMAR DCNVA (Multifocal (test) group) compared to mesopic monocular logMAR BCDVA (control group) in first implanted eyes, second (“fellow”) eyes, and all eyes

○ Photopic monocular logMAR UCDVA (4 m), UCIVA (66 cm), and UCNVA (40 cm) in first implanted eyes, second (“fellow”) eyes, and all eyes

○ Photopic binocular logMAR UCDVA (4 m), UCIVA (66 cm), and UCNVA (40 cm)

○ Residual manifest refractive error from subjective manifest refraction in first implanted eyes, second (“fellow”) eyes, and all eyes 120 to 180 days post-operatively (Visit 4)

▪ Mean error
▪ Mean and median absolute error

○ Percentage of eyes (first implanted eyes, second (“fellow”) eyes, and all eyes) that achieve intended vs achieved Spherical Equivalent within

▪ - +/- 0.50 D
▪ - +/-1.00 D

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○ Percentage of eyes (first implanted eyes, second (“fellow”) eyes, and all eyes) that achieve UCDVA within

▪ 0.00 logMAR or better
▪ 0.20 logMAR or better

○ Percentage of eyes (first implanted eyes, second (“fellow”) eyes, and all eyes) that achieve BCDVA within

▪ 0.00 logMAR or better
▪ 0.20 logMAR or better

Monocular best corrected distance defocus curves in first implanted eyes at 120 to 180 days post-operatively (Visit 4)

With regard to success/failure criteria, the RayOne Galaxy (Model RAO605G) IOL was considered successful as an MIOL if both primary effectiveness endpoints and all primary safety endpoints were met. Secondary effectiveness endpoints were evaluated using a fixed-sequence testing approach. Each secondary effectiveness endpoint was considered successful if the endpoint and all preceding secondary effectiveness endpoints were successful. The RayOne Galaxy (Model RAO605G) IOL would have been considered successful as a full visual range (FVR) IOL if all secondary effectiveness endpoints were met. A separate composite definition of individual patient success was not prespecified.

### B. Accountability of PMA Cohort

At the time of database lock, of 254 patients enrolled in the PMA study, 230 patients were randomized and constituted the ITT population, of whom 95.2% (219/230) were available for analysis at the completion of the study, the 6-month (120 to 180 days) post-operative visit (Visit 4), the final visit evaluated for safety and effectiveness as the basis for the PMA submission.

#### i. Analysis Sets

Refer to TABLE 12 for the number and percentage of subjects included in the study analysis sets. In all tables, ‘N’ refers to the total number of subjects (Multifocal or Monofocal) in the specified analysis set (e.g., ITT or Safety, as indicated). The sets are defined as follows:

- All Enrolled Set – All subjects who signed informed consent.
- Intent-to-Treat (ITT) Set – All enrolled subjects who were randomized.
- Safety Set (SAF) – All ITT subjects who underwent surgery and were exposed to an IOL. Summaries and analyses based on the Safety Set were analyzed according to IOL actually implanted. If no IOL was successfully implanted, but the IOL touched the eye, the subject was analyzed by the attempted lens. If a subject underwent surgery yet no IOL touched the eye, the subject was analyzed in a separate Not Treated group. If it was confirmed that a subject did not undergo surgery, then the subject was excluded from all safety analyses.

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- Per Protocol (PP) Set – All SAF subjects who were successfully implanted with a study lens and who had no major protocol deviations.

- Best Case Set (BCS) – All PP subjects who also met the following criteria:

o No clinically significant pre-operative ocular pathology in the first implanted eye, including any of the following present prior to the Operative Visit:

- Pseudoexfoliation
- Glaucoma
- Uveitis
- Retinal detachment
- Diabetic retinopathy
- Macular degeneration
- Amblyopia
- Other preoperative pathologies that are likely to affect central acuity

o No macular degeneration detected at any time.

o No previous surgery for the correction of refractive errors, which would have resulted in exclusion of the subject from the study.

TABLE 12 SUBJECT ANALYSIS SETS

|  Population (N=230 Randomized) | n (%)  |
| --- | --- |
|  **Intent-to-Treat Set** | 230  |
|  RAO605G Multifocal IOL | 114 (49.6%)  |
|  RAO600C Monofocal IOL | 116 (50.4%)  |
|  |   |
|  **Safety Set** | 227 (98.7%)  |
|  RAO605G Multifocal IOL | 112 (49.3%)  |
|  RAO600C Monofocal IOL | 115 (50.7%)  |
|  |   |
|  **Per Protocol Set** | 209 (90.9%)  |
|  RAO605G Multifocal IOL | 101 (48.3%)  |
|  RAO600C Monofocal IOL | 108 (51.7%)  |
|  |   |
|  **Best Case Set** | 207 (90.0%)  |
|  RAO605G Multifocal IOL | 101 (48.8%)  |
|  RAO600C Monofocal IOL | 106 (51.2%)  |

Abbreviations: n = number of subjects in the specified analysis set or treatment group; N = total number of randomized subjects. Analysis-set percentages are based on the total number of randomized subjects (N = 230). Treatment-group percentages within each analysis set are based on the total number of subjects in that analysis set.

### ii. Accountability of PMA Cohort

Accountability for the ITT set of the Multifocal and Monofocal groups are shown in TABLE 13.

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TABLE 12 presents the number of subjects in each analysis set for all randomized subjects. A total of 230 subjects were randomized in the study and constituted the Intent-to-Treat (ITT) set (114 Multifocal, 116 Monofocal). Of the 230 ITT subjects, 227 underwent surgery and comprised the Safety set. Of these, 209 subjects had no major protocol deviations and thus comprised the Per-Protocol (PP) set; all but two (2) PP subjects were included in the Best Case Set (BCS; n = 207). Eventually, the Multifocal IOL was implanted in 112 subjects, and the Monofocal IOL in 115 subjects.

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TABLE 13 ACCOUNTABILITY - MULTIFOCAL AND MONOFOCAL EYES (ITT SET)

|  Eye | Accountability | Visit 1 (Day 1-2) | Visit 2 (Day 7-14) | Visit 3 (Day 30-60) | Visit 4 (Day 120-180)  |
| --- | --- | --- | --- | --- | --- |
|  **Multifocal Eyes**  |   |   |   |   |   |
|  First Eye (N=114) | Available for Analysis (In Window) | 112 (98.2%) | 107 (93.9%) | 104 (91.2%) | 110 (96.5%)  |
|   |  Available for Analysis (Out of Window) | 0 | 5 (4.4%) | 5 (4.4%) | 0  |
|   |  Missed Visit | 0 | 0 | 1 (0.9%) | 0  |
|   |  Discontinued | 2 (1.8%) | 2 (1.8%) | 2 (1.8%) | 2 (1.8%)  |
|   |  Lost to Follow-up | 0 | 0 | 2 (1.8%) | 2 (1.8%)  |
|   |  % Accountability | 112/112 (100%) | 112/112 (100%) | 109/112 (97.3%) | 110/112 (98.2%)  |
|  Second Eye (N=114) | Available for Analysis (In Window) | 109 (95.6%) | 107 (93.9%) | 107 (93.9%) | 110 (96.5%)  |
|   |  Available for Analysis (Out of Window) | 1 (0.9%) | 2 (1.8%) | 1 (0.9%) | 0  |
|   |  Missed Visit | 1 (0.9%) | 2 (1.8%) | 2 (1.8%) | 0  |
|   |  Discontinued | 2 (1.8%) | 2 (1.8%) | 2 (1.8%) | 2 (1.8%)  |
|   |  Lost to Follow-up | 1 (0.9%) | 1 (0.9%) | 2 (1.8%) | 2 (1.8%)  |
|   |  % Accountability | 110/112 (98.2%) | 109/112 (97.3%) | 108/112 (96.4%) | 110/112 (98.2%)  |
|  All RAO605G Multifocal Eyes (N=228) | Available for Analysis (In Window) | 221 (96.9%) | 214 (93.9%) | 211 (92.5%) | 220 (96.5%)  |
|   |  Available for Analysis (Out of Window) | 1 (0.4%) | 7 (3.1%) | 6 (2.6%) | 0  |
|   |  Missed Visit | 1 (0.4%) | 2 (0.9%) | 3 (1.3%) | 0  |
|   |  Discontinued | 4 (1.8%) | 4 (1.8%) | 4 (1.8%) | 4 (1.8%)  |

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|  Eye | Accountability | Visit 1 (Day 1-2) | Visit 2 (Day 7-14) | Visit 3 (Day 30-60) | Visit 4 (Day 120-180)  |
| --- | --- | --- | --- | --- | --- |
|   | Lost to Follow-up | 1 (0.4%) | 1 (0.4%) | 4 (1.8%) | 4 (1.8%)  |
|   | % Accountability | 222/224 (99.1%) | 221/224 (98.7%) | 217/224 (96.9%) | 220/224 (98.2%)  |
|  **Monofocal Eyes**  |   |   |   |   |   |
|  First Implanted Eye (N=116) | Available for Analysis (In Window) | 113 (97.4%) | 112 (96.6%) | 109 (94.0%) | 109 (94.0%)  |
|   |  Available for Analysis (Out of Window) | 2 (1.7%) | 2 (1.7%) | 4 (3.4%) | 2 (1.7%)  |
|   |  Missed Visit | 0 | 0 | 0 | 0  |
|   |  Discontinued | 1 (0.9%) | 1 (0.9%) | 2 (1.7%) | 3 (2.6%)  |
|   |  Lost to Follow-up | 0 | 1 (0.9%) | 1 (0.9%) | 2 (1.7%)  |
|   |  % Accountability | 115/115 (100%) | 114/115 (99.1%) | 113/114 (99.1%) | 111/113 (98.2%)  |
|  Second Implanted Eye (N=116) | Available for Analysis (In Window) | 113 (97.4%) | 111 (95.7%) | 109 (94.0%) | 108 (93.1%)  |
|   |  Available for Analysis (Out of Window) | 1 (0.9%) | 2 (1.7%) | 2 (1.7%) | 2 (1.7%)  |
|   |  Missed Visit | 0 | 0 | 1 (0.9%) | 0  |
|   |  Discontinued | 2 (1.7%) | 2 (1.7%) | 3 (2.6%) | 4 (3.4%)  |
|   |  Lost to Follow-up | 0 | 1 (0.9%) | 1 (0.9%) | 2 (1.7%)  |
|   |  % Accountability | 114/114 (100%) | 113/114 (99.1%) | 111/113 (98.2%) | 110/112 (98.2%)  |
|  All RAO600C Monofocal Eyes (N=232) | Available for Analysis (In Window) | 226 (97.4%) | 223 (96.1%) | 218 (94.0%) | 217 (93.5%)  |
|   |  Available for Analysis (Out of Window) | 3 (1.3%) | 4 (1.7%) | 6 (2.6%) | 4 (1.7%)  |
|   |  Missed Visit | 0 | 0 | 1 (0.4%) | 0  |
|   |  Discontinued | 3 (1.3%) | 3 (1.3%) | 5 (2.2%) | 7 (3.0%)  |

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|  Eye | Accountability | Visit 1 (Day 1-2) | Visit 2 (Day 7-14) | Visit 3 (Day 30-60) | Visit 4 (Day 120-180)  |
| --- | --- | --- | --- | --- | --- |
|   | Lost to Follow-up | 0 | 2 (0.9%) | 2 (0.9%) | 4 (1.7%)  |
|   | % Accountability | 229/229 (100%) | 227/229 (99.1%) | 224/227 (98.7%) | 221/225 (98.2%)  |

Abbreviations: n = number of eyes in the specified accountability category; N = total number of eyes in the respective treatment and eye group. Accountability-category results are presented as n (%). Percentages for the individual accountability categories are calculated as n/N using the applicable N for the respective treatment and eye group. Available for Analysis (In Window): Total number of eyes for whom data are available at the visit and within the visit window. Available for Analysis (Out of Window): Total number of eyes that were seen at the scheduled visit, but before or after the time window associated with the visit. Missed Visit: Total number of eyes that did not attend the scheduled visit. Discontinued: Total number of eyes that discontinued study participation prior to the visit for any reason, not including subjects that are lost to follow-up. Lost to Follow-up: Total number of eyes that missed the visit and for whom there is no information available. % Accountability: Available for Analysis / (N - Discontinued)

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### C. Study Population Demographics and Baseline Parameters

The demographics of the study population are typical for an intraocular lens clinical study performed in the US.

The distributions of age, gender, race and ethnicity of all ITT subjects are presented in TABLE 14. Subjects ranged in age from 46 to 81 years in the Multifocal group (Mean: 67.3 ± 7.3 years) and from 34 to 81 years in the Monofocal group (Mean: 67.7 ± 7.4 years). The majority (> 90%; 106/114 and 109/116, respectively) of subjects were White in both study groups. Females comprised 61.2 - 64.0% (73/114 and 71/116) of the subjects enrolled in each group, respectively.

The demographic characteristics were generally similar between the Multifocal and Monofocal treatment groups.

TABLE 15 shows the summary statistics for baseline and screening parameters for the ITT. Summary statistics for First Implanted and Second Implanted eyes were similar within and between lens groups.

TABLE 14 SUBJECT DEMOGRAPHICS (ITT SET)

|   |   | Randomized Lens  |   |
| --- | --- | --- | --- |
|  Demographic Parameter | Outcome | RAO605G Multifocal IOL (N=114) | RAO600C Monofocal IOL (N=116)  |
|  Age (years) | N | 114 | 116  |
|   |  Mean ± SD | 67.3 ± 7.3 | 67.7 ± 7.4  |
|   |  Median | 68 | 69  |
|   |  Min, Max | 46, 81 | 34, 81  |
|   |  Q1, Q3 | 64, 72 | 63, 73  |
|  Age Group: n (%) | < 65 years | 30 (26.3%) | 36 (31.0%)  |
|   |  ≥ 65 years | 84 (73.7%) | 80 (69.0%)  |
|  Sex: n (%) | Male | 41 (36.0%) | 45 (38.8%)  |
|   |  Female | 73 (64.0%) | 71 (61.2%)  |
|  Race: n (%) | American Indian or Alaska Native | 0 | 1 (0.9%)  |
|   |  Asian | 4 (3.5%) | 1 (0.9%)  |
|   |  Black or African American | 3 (2.6%) | 3 (2.6%)  |
|   |  Native Hawaiian or Other Pacific Islander | 0 | 1 (0.9%)  |
|   |  White | 106 (93.0%) | 109 (94.0%)  |
|   |  Multiple | 1 (0.9%) | 1 (0.9%)  |

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|   |   | Randomized Lens  |   |
| --- | --- | --- | --- |
|  Demographic Parameter | Outcome | RAO605G Multifocal IOL (N=114) | RAO600C Monofocal IOL (N=116)  |
|   | Other | 0 | 0  |
|  |   |   |   |
|  Ethnicity: n (%) | Hispanic or Latino | 4 (3.5%) | 8 (6.9%)  |
|   |  Not Hispanic or Latino | 110 (96.5%) | 108 (93.1%)  |
|  |   |   |   |
|  First Eye: n (%) | OD | 70 (61.4%) | 56 (48.3%)  |
|   |  OS | 44 (38.6%) | 60 (51.7%)  |

Abbreviations: n = number of subjects in the specified category; N = total number of subjects in the respective randomized treatment group. Categorical results are presented as n (%). Percentages are calculated as n/N using the applicable N for the respective randomized treatment group.

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TABLE 15 BASELINE PARAMETERS (ITT SET)

|   |   | RAO605G Multifocal IOL |   |   | RAO600C Monofocal IOL  |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- |
|  Parameter | Statistic | First Eye^{[1]} | Second Eye | All Eyes | First Eye^{[1]} | Second Eye | All Eyes  |
|  Axial Length (mm) | n | 114 | 114 | 228 | 116 | 116 | 232  |
|   |  Mean ± SD | 23.975 ± 1.219 | 23.936 ± 1.215 | 23.956 ± 1.215 | 24.243 ± 1.226 | 24.194 ± 1.181 | 24.218 ± 1.201  |
|   |  Median | 23.80 | 23.71 | 23.77 | 24.07 | 24.07 | 24.07  |
|   |  Min, Max | 22.01, 28.27 | 21.91, 28.63 | 21.91, 28.63 | 21.57, 27.33 | 21.68, 26.94 | 21.57, 27.33  |
|  |   |   |   |   |   |   |   |
|  Anterior Chamber Depth (mm) | n | 114 | 114 | 228 | 116 | 116 | 232  |
|   |  Mean ± SD | 3.355 ± 0.395 | 3.321 ± 0.378 | 3.338 ± 0.386 | 3.394 ± 0.403 | 3.383 ± 0.398 | 3.389 ± 0.399  |
|   |  Median | 3.32 | 3.32 | 3.32 | 3.41 | 3.39 | 3.40  |
|   |  Min, Max | 2.27, 4.34 | 2.30, 4.30 | 2.27, 4.34 | 2.50, 4.63 | 2.53, 4.60 | 2.50, 4.63  |
|  |   |   |   |   |   |   |   |
|  Photopic BCDVA (logMAR) | n | 114 | 114 | 228 | 116 | 116 | 232  |
|   |  Mean ± SD | 0.244 ± 0.180 | 0.102 ± 0.112 | 0.173 ± 0.166 | 0.281 ± 0.236 | 0.138 ± 0.188 | 0.209 ± 0.224  |
|   |  Median | 0.21 | 0.10 | 0.14 | 0.22 | 0.10 | 0.18  |
|   |  Min, Max | -0.08, 0.92 | -0.18, 0.40 | -0.18, 0.92 | -0.04, 1.10 | -0.20, 1.10 | -0.20, 1.10  |
|  |   |   |   |   |   |   |   |
|  MRSE (D) | n | 114 | 114 | 228 | 116 | 116 | 232  |
|   |  Mean ± SD | -0.9594 ± 2.5021 | -0.6009 ± 2.4603 | -0.7802 ± 2.4823 | -1.6239 ± 3.1324 | -1.1056 ± 2.8376 | -1.3648 ± 2.9934  |
|   |  Median | -0.375 | 0.000 | -0.250 | -1.000 | -0.250 | -0.625  |
|   |  Min, Max | -9.750, 3.250 | -10.000, 2.625 | -10.000, 3.250 | -9.875, 3.500 | -9.250, 3.000 | -9.875, 3.500  |

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|   |   | RAO605G Multifocal IOL |   |   | RAO600C Monofocal IOL  |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- |
|  Parameter | Statistic | First Eye^{[1]} | Second Eye | All Eyes | First Eye^{[1]} | Second Eye | All Eyes  |
|  Target Residual Spherical Equivalent (D) | n | 114 | 114 | 228 | 116 | 116 | 232  |
|   |  Mean ± SD | -0.007 ± 0.113 | -0.000 ± 0.095 | -0.003 ± 0.104 | -0.006 ± 0.108 | -0.002 ± 0.093 | -0.004 ± 0.101  |
|   |  Median | -0.01 | 0.00 | 0.00 | -0.02 | 0.00 | -0.01  |
|   |  Min, Max | -0.50, 0.18 | -0.17, 0.16 | -0.50, 0.18 | -0.18, 0.18 | -0.17, 0.17 | -0.18, 0.18  |
|  |   |   |   |   |   |   |   |
|  Keratometric Cylinder (D) | n | 114 | 114 | 228 | 116 | 116 | 232  |
|   |  Mean ± SD | 0.521 ± 0.255 | 0.530 ± 0.209 | 0.525 ± 0.233 | 0.586 ± 0.244 | 0.533 ± 0.230 | 0.559 ± 0.238  |
|   |  Median | 0.50 | 0.52 | 0.51 | 0.58 | 0.52 | 0.54  |
|   |  Min, Max | 0.00, 0.99 | 0.00, 0.98 | 0.00, 0.99 | 0.06, 0.99 | 0.00, 0.99 | 0.00, 0.99  |

[1]For implanted subjects, First Eye is the First-Implanted Eye and Second Eye is the Second-Implanted Eye. For subjects who were not implanted, the First and Second eyes were determined according to the methods described in the study protocol.

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# D. Safety and Effectiveness Results

# 1. Overall Study Success Criteria

Overall study success was based on meeting the pre-specified primary effectiveness and safety endpoint success criteria. The primary effectiveness success criteria were: (1) mean photopic monocular BCDVA at 4 meters in First Implanted Multifocal eyes at Visit 4 of ≤ 0.20 logMAR, without rounding; and (2) statistically superior photopic monocular DCNVA at 40 cm in First Implanted Multifocal eyes compared with Monofocal control eyes at Visit 4, based on a one-sided signif…

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**Source:** [https://fda.innolitics.com/device/P060011S045](https://fda.innolitics.com/device/P060011S045)

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