DevicePMAs@therightstef:P980006_S000 JSONTXT 11 Projects

Approval for the PureVision(TM) (balafilcon A) Visibility Tinted Contact Lens. This device is indicated for daily or extended wear from 1 to 7 days between removals, for cleaning and disinfection or disposal of the lens, as recommended by the eye care practitioner. The lens is indicated for the correction of refractive ametropia (myopia and hyperopia) in aphakic and/or not-aphakic persons with non-diseased eyes, exhibiting astigmatism of 2.00 diopters or less, that does not interfere with visual acuity.