DevicePMAs@therightstef:P010019_S000 JSONTXT 11 Projects

Approval for the focus night and day (lotrafilcon a) soft contact lenses for extended wear. The device will be marketed with the following trade names and indications: focus night and day (lotrafilcon a) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes and with up to approximately 1.50 diopters of astigmatism. Focus night and day toric (lotrafilcon a) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia in phakic or aphakic persons with non-diseased eyes with 6.00 diopters (d) or less of astigmatism. Focus night and day progressives (lotrafilcon a) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (d) or less and who may have up to approximately 1.50 diopters of astigmatism. The lenses may be prescribed for extended wear for up to 30 nights of continuous wear, with removal for disposal, or cleaning and disinfection prior to reinsertion, as recommended by the eye care professional.