Recently Approved Devices

iStent inject Trabecular Micro-Bypass System (Model G2-M-IS) - P170043
The iStent inject Trabecular Micro-Bypass System (Model G2-M-IS) consists of two small titanium stents (tiny tubes) that are pre-loaded into a stent delivery tool (Model G2-M-IS injector). During cataract surgery (surgery to remove the natural lens that has become cloudy and caused significant vision loss), these stents are implanted into the eye of patients with primary open angle glaucoma (POAG) to help drain fluid that has built up.

enVista® One Piece Hydrophobic Acrylic Toric Intraocular Lens - P910056/S027
The enVista® One-Piece Hydrophobic Acrylic Toric Intraocular Lens, Model MX60T is an artificial lens (Intraocular lens, IOL) implanted in the eye of adult patients for visual correction following the removal of a cataractous lens. Cataracts are often the result of aging, but can have other causes. The enVista MX60T IOL is a toric lens shaped differently from a standard spherical lens, and is intended to correct blurred vision due to an irregularly shaped cornea (astigmatism). This approval adds a new indication to specify that the enVista IOL is approved for use with the Medicel ACCUJECT 2.6-1P injector set, or other injector sets that specifically identify the enVista MX60T lens in the FDA-cleared labeling.