Device Dossier

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

Device Dossier for TECNIS EYHANCE 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 Eyhance IOL which is indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens extends the depth of focus, which improves vision for intermediate tasks, and provides similar distance vision as compared to a standard aspheric monofocal IOL. The lens is indicated for placement in the capsular bag only.

Functional description

The device, model DIB00, contains an ultraviolet-light absorbing posterior chamber IOL which provides distance vision and a dysphotopsia profile comparable to a standard aspheric monofocal IOL. The lens has a modified aspheric anterior surface that is designed to extend depth of focus, which improves intermediate vision as compared to a standard aspheric monofocal IOL. The TECNIS Simplicity™ Delivery System is designed to provide a sterile, controlled and touch-free method of delivering the IOL.

TGA Public Summary