|Approval Order Statement |
Approval for a change in the packaging configuration/ delivery system for the tecnis® 1-piece intraocular lens (iol), model zcb00. The new packaging configuration will function as both the primary packaging for the lens and as a sterile, disposable insertion system for delivering the lens into the eye. The tecnis® 1-piece iol (model zcb00) in the new packaging configuration/ delivery system is designated the tecnis itec preloaded delivery system, model pcb00, and is indicated for the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag.