DevicePMAs@therightstef:N18033_S035 JSONTXT 11 Projects

Approval for an etafilcon a soft (hydrophilic) contact lens for extended wear with uv blocker and the follwoing listed color additives: iron oxide black, iron oxide brown, iron oxide red, iron oxide yellow, titanium dioxide, phthalocyaninato (2-) copper, phthalocyanine green and vat orange 1. The device will be marketed with the following trade names and indicatnions: the acuvue (r) 2 colours contact lenses are indicated for daily wear to enhance or later the apparent color of the eye and/or for the correction of refractive ametropia (myopia and hyperopia) in aphakic or non-aphakic persons with non-diseased eyes who may have 1.00d or less of astigmatism. The acuvue(r) 2 colours (etafilcon a) soft (hydrophilic) bifocal contact lens is indicated for daily wear for the correction of distance and near vision in presbyopic, aphakic or non-aphakic persons with non-diseased eyes who may have 0.75d of astigmatism or less. The acuvue(r) 2 colours (etafilcon a) soft (hydrophilic) toric contact lens is indicated for daily wear for the correction of visual acuity in aphakic or non-aphakic persons with non-diseased eyes that are hyperopic or myopic and may have 10.00d of astigmatism or less. The acuvue(r) 2 colours (etafilcon a) soft (hydrophilic) toric-bifocal contact lens is indicated for daily wear for the correction of distance and near vision in presbyopic aphakic or non-aphakic persons with non-diseased who may have 10.00d or astigmatism or less. Acuvue(r) 2 colours uv blocking contact lenses help protect against transmissino of harmful uv radiatino to the cornea and into the eye. The acutvue(r) 2 colours contact lenses may be prescribed for daily wear. Eye care practitioners may prescribe the lenses either for single-use disposable wear or frequent/planned replacement wear with cleaning, disinfection and scheduled replacement (see "wearing schedule".) when prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfectio