STAAR Says FDA Approves Lens Insertion System

MONROVIA, Calif. (AP) — STAAR Surgical Co. said Thursday it has received Food and Drug Administration approval for the Epiphany Injector System, which is designed to allow surgeons to implant lenses in the eyes of cataract patients.

Shares of the company surged on the news, more than doubling in value, adding $1.55 to $3.01.

STAAR said the device is intended for single use, but can insert the implant in two different ways. The Epiphany system is intended to be used with STAAR's Collamer three piece lens or its Elastimide silicone lens. Epiphany is designed to let surgeons place a lens into the eye through a 2.8 mm incision after they have removed the original lens, which is blocked by a cataract.

The company said the first shipments of the system will be made in July, with a full launch following in August.

The stock also jumped Tuesday after STAAR said its KS-X preloaded lens injector system was approved for use in the European Union.