DevicePMAs@therightstef:P080011_S035 JSONTXT 11 Projects

Approval for a change in trade name for the biofinity energys aspheric lens and expanded powers for the biofinity xr toric and biofinity xr multifocal lenses. the devices, as modified, will be marketed under the trade names biofinity energys asphere, biofinity xr toric, and biofinity xr multifocal (comfilcon a) soft (hydrophilic) contact lenses forextended wear and are indicated for: biofinity energys asphere (comfilcon a) soft contact lenses are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters. the lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. biofinity xr toric (comfilcon a) soft contact lenses are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 d and astigmatism corrections from -0.25 to -5.75 d. biofinity xr multifocal (comfilcon a) lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) with emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 d and with add powers from +0.05 to +4.00 d. the lenses may be worn by persons who exhibitastigmatism of 2.00 d or less that does not interfere with visual acuity.