The US Food and Drug Administration has approved the first stand-alone prosthetic iris, a surgically implanted device to treat adults and children whose irises are completely missing or damaged due to aniridia, a congenital condition, or other damage to the eye.
The device, CustomFlex Artificial Iris, is made of thin, foldable medical-trade silicone and is custom-sized and coloured for each individual patient. It is implanted by a surgeon and held in place by the anatomical structures of the eye or, if necessary, by sutures.