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HYDROGENICS® 2.0 60 UV ASPHERE (ocufilcon F) Soft (Hydrophilic) Contact lenses are indicated for the correction of visual acuity in persons with not-aphakic, non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of 2.00 diopters or less that does not interfere with visual acuity. The HYDROGENIC® 2.0 60 UV ASPHERE (ocufilcon F) Soft (Hydrophilic) Contact Lenses are indicated for daily wear. The eye care practitioner may prescribe the contact lenses for either single use disposable wear or for frequent replacement wear. When prescribed for frequent replacement the lenses may be disinfected using a chemical or hydrogen peroxide disinfecting systems. The HYDROGENICS® 2.0 60 UV ASPHERE (ocufilcon F) Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

HYDROGENICS® 2.0 60 UV ASPHERE (ocufilcon F) Soft (Hydrophilic) Contact Lenses are available with in monomer tint (Vat Blue 6) and with ultraviolet absorbing additive (benzophenone based): - +10.00 D to -10.00 D Asphere - with center thickness from 0.025mm to 0.40mm - . with base curves of 8.00mm to 9.20mm - . with diameter of 12.00mm to 18.00mm The lens material for the HYDROGENICS® 2.0 60 UV ASPHERE (ocufilcon F) is the same as the Biomedics® 60 UV (ocufileon F) lens in spherical design as described in submission K992264 cleared on November 24, 1999. The aspheric lens design for the HYDROGENICS® 2.0 60 UV ASPHERE (ocufilcon F) is the same design construct as the BIOMEDICS® UV ASPHERE (ocufilcon D) as cleared in K020193 on February 28, 2002. The HYDROGENICS® 2.0 60 UV ASPHERE (ocufilcon F) Soft (Hydrophilic) Contact Lens has a spherical posterior surface. The anterior (convex) surface is constructed in lenticular form to provide optimum edge thickness and contour. This front optical surface allows for correction of visual acuity in non-aphakic persons with non-diseased eyes and has been aspherized to control longitudinal spherical aberration of the lens across the power range.