The first prosthetic iris, the CustomFlex Artificial Iris, has been approved by the Food and Drug Administration (FDA) with an indication for individuals with aniridia or other iris defects or injuries. 

The artificial iris, which is made of foldable medical-grade silicone, is placed during a surgical procedure. The device is inserted under a small incision and the surgeon then unfolds it in place; it is secured by the anatomical structures of the eye or, if needed, by sutures. Each iris is custom made. 

Aniridia is a rare, genetic disorder in which the iris is partially or completely missing or damaged. It affects approximately 1 in 50,000 to 100,000 people in the US and can severely affect vision. The FDA’s director of the Division of Ophthalmic, Ear, Nose and Throat Devices Malvina Edelman, MD, said the artificial iris “Provides a novel method to treat iris defects that reduces sensitivity to bright light and glare. It also improves the cosmetic appearance of the eye in patients with aniridia.”

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In a clinical trial of 389 individuals with iris defects, 70% of patients reported a significant decrease in light sensitivity and glare. Additionally, 94% said they were satisfied with the appearance of the device. The rate of adverse events was low though some complications were noted, including: device movement or dislocation, strands of device fiber in the eye, increased intraocular pressure, iritis, synechiae and the need for secondary surgery to reposition, remove or replace the device.

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