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The DuraSoft 3 UV Optifit Toric (phemfilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear in the correction of vision in aphakic and/or not-aphakic persons with non-diseased eyes that are of myopic (nearsighted) or hyperopic (farsighted) and for the correction of astigmatism from 0.75 to 6.00 diopters. The lens ranges in power from -20.00 to +20.00 diopters.

The DuraSoft 3 UV Spherical (phemfilcon A) Soft (hydrophilic) Contact Lenses as indicated for daily wear in the correction of visual acuity in aphakic and/or not-aphakic persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit astigmatism of 2.00 diopters (D) or less that does not interfere with visual acuity. The lens ranges in power from -20.00 to +20.00 diopters.

The lenses indicated are for Daily Wear. The eye care practitioner may prescribe the lenses for daily use with routine daily cleaning, rinsing and disinfection. The lenses may be disinfected using a chemical disinfection system.

The DuraSoft 3 UV Optifit Toric (phemfilcon A) Soft (hydrophilic) Contact Lenses and DuraSoft 3 UV Spherical (phemfilcon A) Soft (hydrophilic) Contact Lenses are hemispherical shells of the following dimensions:

DuraSoft 3 UV Optifit Toric
Chord Diameter: 12.0 to 15.0 mm
Center Thickness: 0.07 to 0.56 mm (varies with power)
Base Curves: 7.80 to 9.00 mm
Powers: -20.00 Diopters to +20.00 Diopters

DuraSoft 3 UV Spherical Lenses
Chord Diameter: 12.0 to 15.0 mm
Center Thickness: 0.05 to 0.56 mm (varies with power)
Base Curves: 7.80 to 9.00 mm
Powers: -20.00 Diopters to +20.00 Diopters

The lens material (phemfilcon A) is a hydrophilic copolymer of 2hydroxyethyl methylcrylate and 2-ethoxyethyl methacrylate. The DuraSoft 3 UV Optifit Toric (phemfilcon A) Soft (hydrophilic) Contact Lenses and the DuraSoft 3 UV Spherical (phemfilcon A) Soft (hydrophilic) Contact Lenses are made by adding the UV absorber to the polymerized rods. Once cured the rods are cut to buttons and then lathed to the proper correction for toric or spherical configurations.

This document is a Summary of Safety and Effectiveness for contact lenses, specifically the DuraSoft 3 UV (phemfilcon A) hydrophilic contact lenses. It is a regulatory filing, not a study report describing an AI device or its performance criteria.

Therefore, items 1-9 of your request cannot be fulfilled by this document because they are specifically about the acceptance criteria and study proving performance for an AI device, which is not the subject of this text.

This document describes:

• The device: DuraSoft 3 UV contact lenses (spherical and toric).
• Indications for Use: Daily wear for correction of vision in aphakic/non-aphakic persons with non-diseased eyes (myopic/hyperopic), and for astigmatism (for the toric lens).
• Substantial Equivalence: The primary focus of this submission is to demonstrate substantial equivalence for the addition of a UV absorber to existing DuraSoft 3 lenses. The modification involves a change in the manufacturing process (adding the UV absorber to polymerized rods instead of an in-molding process).
• Device Description: Physical dimensions and material composition of the lenses.
• Physical Properties: Specific gravity, refractive index, light transmittance, surface characteristics, water content, optical zone, and oxygen transmissibility.

It is important to reiterate that this document does not discuss an AI device, acceptance criteria related to AI performance, or any studies proving such performance.

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