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The Contact Color COSMETICA (Polymacon) soft (hydrophilic) contact lenses are indicated for daily wear to enhance or alter the apparent color of the eye, including ocular masking, either in sighted or non-sighted eyes that require a prosthetic contact lens for the cosmetic management of conditions such as scleral, corneal, iris, or lens abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia and hyperopia) in aphakic and not aphakic persons or for occlusive therapy for conditions such as diplopia or extreme photophobia. The lenses may be disinfected using chemical disinfection systems.

Contact Color COSMETICA (Polymacon) soft (hydrophilic) contact lenses are daily wear soft contact lenses for use in enhancing or altering the apparent color of the eye for prosthetic and theatrical use. The lenses used to produce Contact Color COSMETICA (Polymacon) soft (hydrophilic) contact lenses are Benz 38 (Polymacon) Soft (Hydrophilic) Daily Wear Contact Lens (Clear) supplied by Benz Research & Development of Sarasota, Florida. These lenses have received FDA premarket clearance (K961103). The Benz 38 lens material is polymacon, which in the hydrated state consists of 62% hydrophilic polymer of 2-hydroxyethylmethacrylate (2-HEMA) and 38% water. The Contact Color COSMETICA (Polymacon) soft (hydrophilic) contact lenses are made by incorporating by hand an opaque pigment in an iris pattern between two layers of the polymacon polymer.