DevicePMAs@therightstef:P880081_S032 JSONTXT 11 Projects

Approval for a change in haptic material, addition of the optiedge and of a modified prolate anterior optic surface to the si20nb lens and labeling claims for reduced postoperative spherical aberrations and improved night-driving simulator performance. The device, as modified, will be marketed under the trade name tecnis cl foldable silicone posterior chamber intraocular lens (model z9002) and is indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular extraction or phacoelmulsifica-tion. These devices are intended to be placed in the capsular bag.