Device Dossier
Tecnis Synergy Toric II OptiBlue IOL with Tecnis Simplicity Delivery System - Lens, intraocular, posterior chamber
Device Dossier for Tecnis Synergy Toric II 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™ Toric II OptiBlue™ IOL which is indicated for the primary implantation for the visual correction of aphakia and pre-existing corneal astigmatism in [1] astigmatic adult patients with and without presbyopia in whom a cataractous lens has been removed by phacoemulsification and [2] aphakia following refractive lensectomy in astigmatic presbyopic adults, who desire improved uncorrected vision, reduction of residual refractive cylinder, useful near vision and reduced spectacle dependence across a range of distances. The intraocular lenses are intended to maintain rotational stability after implantation in the capsular bag.
Functional description
The device, model DFW, contains an ultraviolet and violet light-filtering posterior chamber IOL, intended to provide high-quality, continuous vision over a full range of distances, to increase spectacle independence and compensate for corneal spherical aberration and corneal astigmatism. 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 delivery.