DevicePMAs@therightstef:P970034_S000 JSONTXT

Indicated for the visual correction of aphakia in persons 60 years of age or older, who are undergoing extracapsular cataract extraction and primary lens implantation. The intraocular lens is intended to permanently replace the natural cataractous crystalline lens and to restore useful vision. It is intended for capsular bag placement only. The devices are available in a range of powers from 4 diopters (D) to 34D in 0.5D increments.