DevicePMAs@therightstef:P990013_S014 JSONTXT 11 Projects

Approval for parametric lot release using existing validated steam sterilization cycles. The device, as modified, will be marketed under the trade name collamer ultraviolet-absorbing posterior chamber intraocular lens and is indicated for the visual correction of aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by phacoemulsification cataract extraction. The lens is to be implanted in the posterior chamber and in the capsular bag through a tear-free capsulorhexis (circular tear anterior capsulotomy).