Device Dossier
TECNIS Synergy™ OptiBlue™ IOL with TECNIS Simplicity™ Delivery System - Lens, intraocular, posterior chamber
Device Dossier for TECNIS Synergy™ OptiBlue™ IOL with TECNIS Simplicity™ Delivery System - Lens, intraocular, posterior chamber (Lens, intraocular,…
- GMDN category: Lens, intraocular, posterior chamber
Intended purpose
The TECNIS Simplicity™ Delivery System is used to fold and assist in inserting the TECNIS Synergy™ OptiBlue™ IOL which is indicated for primary implantation for the visual correction of: [1] aphakia in adults in whom a cataractous lens has been removed, and [2] aphakia following refractive lensectomy in presbyopic adults who may benefit from useful near vision and reduced spectacle dependence across a range of distances. The lens is intended to be placed in the capsular bag.
Functional description
The device, model DFR00V, contains a foldable acrylic 1-piece ultraviolet and violet light-filtering IOL, intended to provide high-quality vision over a full range of distances, including far, intermediate and near to increase spectacle independence. It is designed to be positioned in the lens capsule to replace the optical function of the natural crystalline lens. The Delivery System is designed to provide a sterile, controlled and touch-free method of delivering the lens into the eye.