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The SAUFLON CLARITI (somofilcon A) Soft (hydrophilic) Contact Lens with UV blocker and handling tint is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Diopters that does not interfere with visual acuity. The SAUFLON CLARITI TORIC (somofilcon A) Soft (hydrophilic) Contact Lens with UV blocker and handling tint is indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 10.00 Diopters. The SAUFLON CLARITI MULTIFOCAL (somofilcon A) Soft (hydrophilic) Contact Lens with UV blocker and handling tint is indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes that may require a reading addition of +4.00 Diopters or less. The SAUFLON CLARITI MULTIFOCAL TORIC (somofilcon A) Soft (hydrophilic) Contact Lens with UV blocker and handling tint is indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 10.00 Diopters and that may require a reading addition of +4.00 Diopters or less. The lenses may be prescribed for daily wear for up to one month with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion as recommended by the eye care professional. Sauflon Clariti (somofilcon A) Soft (hydrophilic) Contact lens with UV blocker and handling tint helps protect against transmission of harmful UV radiation to the cornea and into the eye. The lens has a tint added to make the lens more visible for handling.

The Sauflon Clariti (somofilcon A) Soft (Silicone Hydrogel) Contact Lens with UV Blocker and handling tint is available as a single vision, toric and multifocal lens. The lens material (somofilcon A) is a hydrophilic co-polymer of silicone containing monomers and hydrophilic monomers which is cross-linked with Alkyl bis methacrylate. When hydrated the lens consists of 44.0% somofilcon A and 56.0% water by weight of saline immersed in normal saline. A benzophenone UV absorbing monomer is used to block UV radiation. A D&C Green 6 tint is also included in the composition of the lens for ease of handling and visibility. The average transmittance characteristics are less than 5% in the UVB range of 280 to 315nm and less than 50% in the UVA range of 316-380nm The Sauflon Clariti (somofilcon A) Soft (hydrophilic) Contact Lens with UV Blocker and Handling Tint is spherical flexible shell, which covers the cornea and a portion of the adjacent sclera, with the following dimensions: • Chord Diameter: 13.0 to 18.0mm • Centre Thickness: 0.03 to 0.70mm • Base Curve: 7.5 to 9.5mm • Powers: -30.00 DS to +30.00 DS • Toric cylinder options: Between -0.75 and -9.75 • Toric Axis options: 10° to 180° (5° steps) • Multifocal ADD: Add power of up to +4.00, labelled with indicative add strength to be read in conjunction with the fitting guide. The physical/optical properties of the lenses are: · Refractive Index: 1.4008 · %Transmittance @ 590nm: 98.30% . %Transmittance @ 280-315nm: 0.71 . . %Transmittance @ 316-380nm: 20.62 . Surface Character: Hydrophilic Water Content: . 56% 60 x 10-11 (cm2/sec) (ml O2/ml x mmHg) Oxygen Permeability (DK): . at 35°C (Fatt Method for determination of oxygen permeability). 1.17 Specific Gravity:

The SAUFLON CLARITI (somofilcon A) Soft (hydrophilic) Contact Lens with UV blocker is indicated for monthly disposable wear for the correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Diopters that does not interfere with visual acuity. The SAUFLON CLARITI TORIC (somofilcon A) Soft (hydrophilic) Contact Lens with UV blocker is indicated for monthly disposable wear for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with nondiseased eyes that may exhibit astigmatism up to 10.00 Diopters. The SAUFLON CLARITI MULTIFOCAL (somofilcon A) Soft (hydrophilic) ontact Lens with UV blocker is indicated for monthly disposable wear for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes that may require a reading addition of +3.00 Diopters or less and may exhibit astigmatism up to 1.50 Diopters or less. The SAUFLON CLARITI MULTIFOCAL TORIC (somofilcon A) Soft ydrophilic) Contact Lens with UV blocker is indicated for monthly disposable wear for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 10.00 Diopters and that may require a reading addition of +3.00 Diopters or less. The lenses may be prescribed for daily wear with removal for cleaning and isinfection (chemical, not heat) prior to reinsertion as recommended by the eye care professional. Sauflon Clariti (somofilcon A) Soft (hydrophilic) Contact lens with UV blocker help protect against transmission of harmful UV radiation to the cornea and into the eye.

The Sauflon Clariti (somofilcon A) Soft (Silicone Hydrogel) Contact Lens with UV Blocker is available as a single vision, toric, multifocal and multifocal toric lens. The lens material (somofilcon A) is a hydrophilic co-polymer of silicone containing monomers and hydrophilic monomers which is cross-linked with tetraethyleneglycol dimethacrylate. When hydrated the lens consists of 44.0% somofilcon A and 56.0% water by weight of saline immersed in normal saline. A benzophenone UV absorbing monomer is used to block UV radiation. The average transmittance characteristics are less than 5% in the UVB range of 280 to 315nm and less than 50% in the UVA range of 316-380nm The Sauflon Clariti (somofilcon A) Soft (hydrophilic) Contact Lens with UV Blocker is a hemispherical flexible shell, which covers the cornea and a portion of the adjacent sclera, with the following dimensions: - Chord Diameter: 13.0mm to 15.5mm ● Centre Thickness: 0.03mm to 0.50mm . 7.5mm to 9.30mm Base Curve: . Powers: -20.00 DS to +20.00 DS . . Toric Cylinder options: -0.75, -1.25, -1.75 and -2.25 - Toric Axis options: . - . Multifocal Add: 10° to 180° (10° steps). Lens "LOW" = "low" for spectacle near ADD lens (Max +2.25 ADD) Lens "HIGH" = "high" for spectacle near ADD lens (+2.50 ADD or greater) The physical/optical properties of the lenses are: • Refractive Index: 1.4003 • %Transmittance @ 590nm: 98.13 • %Transmittance @ 280-315nm: 0.71 • %Transmittance @ 316-380nm: 20.62 • Surface Character: Hydrophilic • Water Content: 56% • Oxygen Permeability (DK): 60 x 10-11 (cm²/sec) (ml O2/ml x mmHg) at 35°C (Fatt Method for determination of oxygen permeability). • Specific Gravity: 1.17

The SAUFLON CLARITI 1-DAY (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV Blocker is indicated for daily wear single use only for the correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Diopters that does not interfere with visual acuity. The SAUFLON CLARITI 1-DAY TORIC (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV Blocker is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 10.00 Diopters. The SAUFLON CLARITI 1-DAY MULTIFOCAL (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV Blocker is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes that may require a reading addition of +3.00 Diopters or less and may exhibit astigmatism up to 1.50 Diopters or less. The SAUFLON CLARITI 1-DAY MULTIFOCAL TORIC (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV Blocker is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 10.00 Diopters and require a reading addition of +3.00 Diopters or less. The eye care professional should prescribe the lenses for daily wear single use only. The lenses are to be discarded upon removal; therefore, no cleaning or disinfecting is required. Sauflon Clariti 1-Day (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lenses with UV Blocker help protect against transmission of harmful UV radiation to the cornea and into the eye.

The Sauflon Clariti I Day (somofileon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV Blocker is available as a single vision, toric and multifocal The lens material (somofileon A) is a hydrophilic co-polymer of silicone lens. containing monomers and hydrophilic monomers which is cross-linked with tetraethyleneglycol dimethacrylate. When hydrated the lens consists of 44.0% somofilcon A and 56,0%, water by weight of saline immersed in normal saline. A benzophenone UV absorbing monomer is used to block UV radiation: The average transmittance characteristics are less than 5% in the UVB range of 280 to 315nm and less than 30% in the UVA range of 316-380nm The Sauffon Clariti 1 Day (somofileon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV Blocker is a hemispherical flexible shell, which covers the cornea and a portion of the adjacent sciera, with the following dimensions; • Chord Diameter: 13.0mm to 15.5mm • Centre Thickness: 0.03mm to 0.50mm • Base Curve: 7.5mm to 9.30mm • Powers: -20.00 DS to +20.00 DS • Toric Cylinder options: -0.75, -1.25, -1.75 and -2.25 • Toric Axis options: 10° to 180° (10° steps). - Multifocal Add: . Lens "LOW" = "low" for spectacle near ADD lens (Max +2.25 ADD) Lens "HIGH" = "high" for spectacle near ADD lens (+2.50 ADD or greater) The physical/optical properties of the lenses are: Refractive Index: 1.4003 %Transmittance @ 590nm: 98.13 %Transmittance @ 280-315nm: 0.71 %Transmittance @ 316-380nm: 20.62 Surface Character: Hydrophilic Water Content: 56% Oxygen Permeability (DK): 60 x 10-11 (cm2/sec) (ml O2/ml x mmHg at 35°C (Fatt Method for determination of oxygen permeability). Specific Gravity: 1.17

Sauflon Multipurpose Solution is indicated for use in the daily cleaning, rinsing, disinfection, removal of proteins, storage and conditioning of soft (hydrophilic) contact lenses including silicone hydrogel lenses, as recommended by the eye care practitioner.

Sauflon Multipurpose Solution is a sterile, isotonic solution that contains poloxamer, sodium phosphate buffer, sodium chloride, and disodium edetate; preserved with polyhexanide 0.0001%. Contains no chlorohexidine or thimerosal.

The Sauflon New Day® (methafilcon A) Soft (hydrophilic) Visibility tinted contact lens is a daily disposable lens indicated for the correction of the refractive ametropia (myopia and hyperopia) and astigmatism in aphakic and not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Dioptres that does not interfere with visual acuity.

The SAUFLON New Day® (methafilcon A) Soft (Hydrophilic) Visibility Tinted Daily Disposable Contact Lenses are available in an aqua visibility tint. The lens material (methafilcon A) is a hydrophilic polymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid, which is cross-linked with ethyleneglycol dimethacrylate. When hydrated the lens consists of 45% HEMA and 55% water by weight of saline immersed in normal saline. The lens is visibility tinted aqua with weight of summe inimelod in his meller on the well and one UV absorbing monomer is used to block UV radiation. Sauflon New Day lenses are daily disposable lenses. The average transmittance characteristics are less than 10% in the UVB range of 280 to 315nm and less than 40% in the UVA range of 315-380nm. The SAUFLON New Day Daily Disposable Lens is a hemispherical flexible shell, which covers the cornea and a portion of the adjacent sclera.

Storage of soft (hydrophilic), hard and rigid gas permeable (RGP) contact lenses during chemical disinfection only. Not to be used for heat disinfection.

The SAUFLON Flat Coloured Lens Case are moulded plastic, flat style cases with screw top lids, similar in design to currently marketed products.

Storage of soft (hydrophilic), hard and rigid gas permeable (RGP) contact lenses during chemical disinfection only. Not to be used for heat disinfection.

The SAUJFLON contact lens cases are moulded plastic, flat or barrel style cases with screw top leads, similar in design to currently marketed products. The barrel style include a lens basket used for holding the lens during storage.

The Sauflon Multipurpose Solution is indicated for use in the daily cleaning, rinsing, chemical (not heat) disinfection, removal of proteins and storage of soft (hydrophilic) contact lenses, as recommended by the eye care practitioner

Sauflon Multipurpose Solution is a sterile, isotonic solution that contains poloxamer, sodium phosphate buffer, sodium chloride, and disodium edetate; preserved with polyhexanide 0.0001%. Contains no chlorohexidine or thimerosal. Sauflon Multipurpose Solution remains unchanged from the previously approved product in K974485, except for the revised directions for use.

The Sauflon 55 UV soft (hydrophilic) contact lens is indicated for daily wear for the correction of the refractive ametropia (myopia and hyperopia) and astigmatism in aphakic and not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Dioptres that does not interfere with visual acuity. Eyecare practitioners may prescribe the lens for daily wear in a Frequent Replacement Program. The lenses may be disinfected using chemical or hydrogen peroxide disinfection systems.

The SAUFLON 55UV (methafilcon A) Soft (Hydrophilic) Visibility Tinted Contact Lenses for Daily Wear is available as a single vision lens in an aquamarine visibility tint. The lens material (methafilcon A) is a hydrophilic polymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid, which is cross-linked with ethyleneglycol dimethacrylate. When hydrated the Inns consists of 45.0% HEMA and 55.0% water by weight of saline immersed in normal saline. The lens is visibility tinted aqua with: Reactive Blue No. 4 and Reactive Yellow Dye # 86. A benzophenone UV absorbing monomer is used to block UV radiation. The average transmittance characteristics are less than 10% in the UVB range of 280 to 315nm and less than 40% in the UVA range of 315-380mm. The SAUFLON 55 UV Contact Lens is a hemispherical flexible shell, which covers the cornea and a portion of the adjacent sclera.