Device Dossier

TECNIS Eyhance™ Toric II IOL with TECNIS Simplicity Delivery System - Lens, intraocular, posterior chamber

Device Dossier for TECNIS Eyhance™ Toric II IOL with TECNIS Simplicity Delivery System - Lens, intraocular, posterior chamber (Lens, intraocular,…

Intended purpose

The TECNIS Simplicity™ Delivery System is used to fold and assist in inserting the TECNIS Eyhance™ Toric II IOL which is indicated for the visual correction of aphakia and pre-existing corneal astigmatism in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens reduces the residual refractive cylinder and 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 DIU, contains an ultraviolet-light absorbing posterior chamber IOL, intended to provide distance vision and a dysphotopsia profile comparable to a standard aspheric monofocal IOL. The lens is designed to correct corneal astigmatism and extend depth of focus, which improves intermediate vision as compared to a standard aspheric monofocal IOL, and also compensates for corneal spherical aberration. The Delivery System provides a sterile, controlled and touchfree method of delivery

TGA Public Summary