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The Clearcolor 1- Day (hioxifilcon A) and Aryancolor 1-Day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic person with non-diseased eyes who may have 1.00 D or less of astigmatism. The lens is intended to be worn once and then discarded at the end of each wearing period on a daily basis. The patient should be instructed to start the next wearing period with a new lens. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.

The subject device, Clearcolor 1- Day (hioxifilcon A) Daily Disposable Device Soft (hydrophilic) Contact Lens and Aryancolor 1-Day (hioxifilcon A) Description Daily Disposable Soft (hydrophilic) Contact Lens is a Soft Hydrophilic Daily Disposable Color Soft Contact Lens. The subject device is made of a nonionic lens material, hioxifilcon A, which is a random co-polymer of 2-Hydroxyethyl methacrylate (2-HEMA) and glycerol methacrylate (HEMA/GMA) cross-linked with ethylene glycol dimethacrylate. The copolymer consists of 42% hioxifilcon A and 58% water by weight when immersed in normal buffered saline solution. The hioxifilcon A name has been adopted by the United States Adopted Names Council (USAN). The subject device is a cosmetically tinted contact lens and contains a pigmented area that will mask or enhance the color of the natural iris. The cosmetically tinted lenses contain one or more of the following US FDA approved colorants for contact lenses: D&C Yellow, No. 10, D&C Green, D&C Red No. 17, Phthalocyanine-2-Copper, Carbazole Violet, Titanium dioxides, reactive Black 5, C.I. Vat Orange 1, C.I. Vat yellow 3, C.I. Pigment Green, C.I. Vat Orange 5, C.I. Vat Brown 1, C.I. Vat Green 1, Pigment Blue 36, and Iron Oxides. These colorants will be used to make 1-tone, 2-tone and 3-tone color patterns on contact lenses. The cosmetically tinted lens is available in variety of opaque colors including: Gray, Brown, Tan Brown, Black, Green, and Blue.