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Spherical: ProSoft™ Spherical (phemfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 2.00 diopters that does not interfere with visual acuity. The lens range in power from -20.00 to +20.00 diopters for daily wear. Toric: ProSoft™ Toric (phemfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 6.00 diopters. The lens ranges in power from -20.00 to +20.00 diopters for daily wear. The Spherical and Toric lenses may be prescribed for daily wear in not-aphakic or aphakic persons. The eye care practitioner may prescribe the lens with routine cleaning, rinsing and disinfection. The lens may be disinfected using a chemical (not heat) disinfection system only. ProSoft Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

ProSoft Spherical and Toric (phemfilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear are hemispherical shells of the lens material (phemfilcon A), which is a hydrophilic copolymer of 2hydroxyethyl methacrylate and 2-ethoxyethyl methacrylate. Once cured the rods are cut to buttons and then lathed to the proper spherical or toric configuration. The ProSoft contact lenses are made by adding Vat Green #1 dye to the finished lens using the CTL (custom tinting) process. Prosoft lenses enhance perception of colored objects relative to other background colors. This enables the wearer to see a ball or selected objects with greater clarity than with the naked eye, on the tennis court, golf course or other background.

Spherical: DuraSoft® 3 Spherical (phemfilcon A) Clear, Colored, Complements ColorBlends and Handling Tint Soft (Hydrophilic) Contact Lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 2.0 diopters that does not interfere with visual acuity. The lens range in power from -20.00 to +20.00 diopters for daily wear. OptiFit Toric: DuraSoft® 3 OptiFit Toric (phemfilcon A) Clear, Colored, Complements ColorBlends and Handling Tint Soft (Hydrophilic) Contact Lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 6.0 diopters. The lens range in power from -20.00 to +20.00 diopters for daily wear. Prosthetic: DuraSoft® 3 Prosthetic (phemfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for Daily Wear to enhance or alter the apparent eye color, including ocular masking, either in sighted or non-sighted eyes that require a prosthetic contact lens for cosmetic management of conditions such as comeal, ins or lens abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) or for occlusive therapy conditions such as diplopia, amblyopia or extreme photophobia. The lenses are indicated for Daily Wear in not-aphakic and/or aphakic persons. The eve care practitioner may prescribe the lens for daily use with routine cleaning, ninsing and disinfection. The lens may be disinfected using a chemical (not heat) disinfection system only. DuraSoft 3 Contact Lenses with UV-absorbing monomer help protect against transmission of harmful UV radiation to the comea and into the eye.

The dimensions of DuraSoft® 3 and DuraSoft® 3 UV (phemfilcon A) Spherical and OptiFit Toric hydrophilic contact lenses in Clear, Colors, Complements, ColorBlends and Handling Tint are the same as approved in PMA 830037/S41 and K982344. The lens material (phemfilcon A) is a hydrophilic copolymer of 2-hydroxyethyl methacrylate and 2-ethoxyethyl methacrylate. The DuraSoft® 3 UV (phemfilcon A) contact lenses are made by adding the UV absorber to the monomer mixture. The physical properties of the lenses are listed below. The light transmittance table has been added as approved for the Supplement No. 42 PMA P830037 and 510(k) K991550 (FreshLook Bifocal UV-absorbing (phemfilcon A) contact lenses). The data to support this table is available in Section X, Exhibit -3. Physical properties of the lenses: Specific Gravity: 1.178 Refractive Index: 1.411 Light Transmittance: Handling Tint: 95% minimum Color: 95% minimum Surface Characteristics: Lathed and polished Water Content: 55% Optical Zone: Handling Tint: 5 mm to 9 mm (varies with power) Colors: 5 mm Oxygen Transmissibility (Dk/L): 32.2 x 10 to the power of -9 ml O2 cm at 35° C sec ml mm Hg Light Transmittance a) Visible (600 nm)≥95% b) UV (250-400 nm) † DuraSoft® 3UV with Handling Tint UVA (315-380 nm) +2.00 0.6, -4.00 4.0, -3.00* 2.3 UVB (280-315 nm) +2.00 3.1, -4.00 10.7, -3.00* 7.3 DuraSoft® 3UV with Carbazole violet in-monomer tint UVA (315-380 nm) +2.00 0.7, -4.00 2.7, -3.00* 2.9 UVB (280-315 nm) +2.00 1.7, -4.00 5.2, -3.00* 5.6 † The referenced data was determined from "Methods for Determining Ultraviolet Transmission of UV-blocking Contact Lenses," by Dr. H. Faubl, International Contact Lens Clinic, Vol. 25, no.5, 1998. Representative of the thinnest lens design.

The Gentle Touch UV (netrafilcon A) soft (hydrophilic) contact lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Diopters that does not interfere with visual acuity. The lens is to be disinfected using a recommended chemical (not heat) disinfection system or hydrogen peroxide disinfection system. Gentle Touch UV (netrafilcon A) lenses help to protect against transmission of harmful UV radiation to the comea and into the eye.

The GentleTouch UV (netrafilcon A) soft (hydrophilic) contact lenses are available as handling tinted hemispherical lenses with base curves of 8,2 mm and 8,5 mm and a diameter of 14.5 mm. The lens may be worn by persons that require a spherical lens in the power range from -20,00 to +20,00 Diopters (D) for daily wear. The lens material, netrafilcon A, is a hydrophilic copolymer of N.N-dimethyl acrylamide, methyl methacrylate, with a UV absorbing monomer (UVAM) and Inmonomer tint. It consists of 65% water and 35% netrafileon A. The lenses are manufactured by injecting a small amount of netrafilcon A monomer into a polypropylene mold and then thermally cured.

FreshLook® Bifocal UV-absorbing Spherical (phemfilcon A) Soft (Hydrophilic) Contact Lenses are Indicated for the correction of visual aculty and presbyoble in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 0.75 diopters that does not interfers with visual acuity. The lenses may be prescribed for Daily Wear in aphakic or not applantic persons. The eye care practitioner may prescribe the lenses in either a single use daily disposable program or in a frequent replacement program with cleaning, disinfection and scheduled replacement. When prescribed in the frequent replacement program, the lenses may be disinfected using a chemical disinfection system. FreshLock Lenses with UV-absorbing money help protect against transmission of harmful UV rediation to the comes and Into the eye.

The FreshLook® Bifocal UV-absorbing (phemfilcon A) Spherical Soft (Hydrophilic) contact lenses in Handling Tint and Colors are hemispherical shells indicated for the correction of visual acuity in presbyopic patients for daily wear. The generic name (USAN) is phemfilcon A. The form in which the device is to be delivered is a contact lens immersed in 0.9% sodium chloride solution. Exclusive of the saline solution, the lens is a hydrophilic polymer swollen with water, in the polymer/water weight ratio of 45/55 respectively. The components of the FreshLook® Bifocal UV-absorbing lenses are identical to the currently manufactured FreshLook® UV. The lens material (phemfilcon A) is a hydrophilic copolymer of 2-hydroxyethyl methacrylate and 2-ethoxyethyl methacrylate and a proprietary UV absorbing monomer which has been incorporated into the polymer matrix of the lens to absorb ultraviolet (UV) light.

Precision UV™ (vasurfilcon A) Hydrophilic Contact Lenses are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic or hyperopic and may have 2.00 diopters(D) or less of comeal astigmatism that does not interfere with visual acuity. The contact lenses may be prescribed for daily wear. The eye care practitioner may prescribe the contact lens for either single-use disposable wear or for frequent replacement wear, with cleaning, disinfecting and scheduled replacement. When prescribed for frequent replacement wear, the contact lens may be disinfected using a chemical, heat or hydrogen peroxide disinfecting system. Precision UV lenses help protect against transmission of harmful UV radiation to the comea and into the eye.

Precision UV™ (vasurfilcon A) Hydrophilic Contact Lenses are available as clear and locator tinted spherical lenses in the power range from -16.00 to + 10.00 diopters, center thickness from 0.09 - 0.17 mm (minus lenses) and 0.22 - 0.41 mm (plus lenses) with base curves of 8.4 and 8.7mm and a diameter of 14.4mm. The lens material. vasurfilcon A. is a hydrophilic random copolymer of N-vinyl-pyrrolidone (NVP), Methl methacrylate (MMA), Allyl methacrylate (AMA), Ultraviolet absorbing monomer (UVAM) and AIBN (Azo-Iso-butyronitrile) as an initiator. It consists of 74% water and 26% vasurfilicon A.

The DuraSoft® 3 UV Optifit Toric (phemfilcon A) Clear, Colored, Complements and Handling Tint Soft (Hydrophilic) contact lenses are indicated for daily wear in the correction of vision acuity in aphakic and for not-aphakic person with non-diseased eyes that are 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 for daily wear. The DuraSoft® 3 UV Spherical (phemfilcon A) Clear, Colored, Complements and Handling Tint Soft (Hydrophilic) contact lenses are 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 diopter (D) or less that does not interfere with visual acuity. The lens ranges in power from -20.00 to +20.00 diopters for daily wear. 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. Additional information is available in the Wearing Schedule Section of the package insert, patient instruction and fitting quide. The lenses may be disinfected using a chemical disinfection system.

The DuraSoft® 3 UV (pherical and Optifit Toric hydrophilic contact lenses in Clear, Colors, Complements and Handling Tint are hemispherical shells of the lens material (phemfilcon A). A hydrophilic copolymer of 2-hydroxyethy) methacrylate and 2-ethoxyethyl methacrylate. The DuraSoft® 3 UV Optifit Toric Contact lenses and DuraSoft® 3 UV (phemfilcon A) Spherical Contact Lenses are made by adding the UV absorber and carbazole violet in-monomer tint to the monomer mixture. Once cured the rods are cut to buttons and then lathed to the proper correction for toric or spherical configuration.

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.

The DuraSoft 2 FreshLook Colors (phemfilcon A) Soft (hydrophilic) Contact Lenses and the DuraSoft 2 FreshLook LiteTint (phemfilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear in the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eves that are revopic (nearsighted) or hyperopic (farsighted) and may exhibit astigmatism of 0.75 diopters (D) or less that does not interfere with visual acuity. The lenses indicated are for Daily Wear (for available powers see Lens Description Section). Eve care practitioner may prescribe the lens for either single-use disposable daily wear or for frequent replacement wear for daily use, with cleaning, rinsing, disinfection and scheduled replacement from one to 14 days of use. (See Wear Schedule Section for additional information.) When prescribed for frequent replacement wear, the lens must be disinfected using either chemical or heat disinfection systems.

The DuraSoft 2 FreshLook Colors (phemfilcon A) Soft (hydrophilic) Contact Lenses and DuraSoft 2 FreshLook LiteTint (phemfilcon A) Soft (hydrophilic) Contact Lenses are hemispherical shells of the following dimensions: Chord Diameter: 12.0 to 15.0 mm Center Thickness: 0.08 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 2-hydroxyethy) methylcrylate and 2ethoxyethyl methacrylate. The DuraSoft 2 FreshLook Colors (phemfilcon A) Soft (hydrophilic) Contact Lenses are made by modifying the clear lens by affixing a colored pigment on that portion of the front surface of the lens which corresponds to the iris. The colored pigments consist of the following color additives listed in the Color Additive Provisions of the Code of Federal Requilations 21 CFR Section 706. All colored lenses contain iron oxides, titanium dioxide and [phthalocyaninato (2-1)] copper. In addition, the green lens contains chromium oxide and the violet lens contains carbazole violet. The DuraSoft 2 FreshLook Colors (phemfilcon A) Soft (hydrophilic) Contact Lenses are available in the following opaque colors: Blue, Green, Hazel and Violet. The DuraSoft 2 FreshLook LiteTint (phemfilcon A) Soft (hydrophilic) Contact Lenses is tinted green with the color additive, phthalocyanine green for easy visibility for handling. The physical properties of the lenses are: Specific Gravity: 1.176 Refractive Index: 1.440 Light Transmittance: FreshLook LiteTint: 95% minimum FreshLook Colors: 97% minimum Surface Characteristics: Hydrophilic Water Content: 38% Optical Zone (FreshLook Colors): 5 mm (FreshLook LiteTint): 5 mm to 9 mm (Varies with power) Oxygen Transmissibility: Dk/L = 12.9 x 10-9 ml O2 cm@ 35°C sec ml mm Hg