DevicePMAs@therightstef:P930014_S014 JSONTXT 11 Projects

Approval to modify the indications statement, to indicate the iols for use in adult patients following cataract surgery. Previously, the iols were indicated for use in persons 60 years of age or older when extracapsular cataract extraction or phacoemulsification are performed or where a cataractous lens has been removed. The device is indicated for the replacement of the human lens to achieve visual correction of aphakia in adults following cataract surgery.