Device Dossier

TECNIS 1-Piece IOL with TECNIS Simplicity Delivery System - Lens, intraocular, posterior chamber

Device Dossier for TECNIS 1-Piece IOL with TECNIS Simplicity Delivery System - Lens, intraocular, posterior chamber (Lens, intraocular, posterior…

Intended purpose

The TECNIS Simplicity™ Delivery System is used to fold and assist in inserting the TECNIS® 1-Piece intraocular lens for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. These devices are intended to be placed in the capsular bag.

Functional description

The device, model DCB00, contains an ultraviolet-light absorbing posterior chamber intraocular lens which compensates for corneal spherical aberrations. It is designed to be positioned in the lens capsule where the lens should replace the optical function of the natural crystalline lens. The TECNIS Simplicity™ Delivery System is designed to provide a sterile, controlled and touch-free method of delivering the TECNIS® 1-Piece lens into the eye.

TGA Public Summary