FDA approves artificial iris - WTOC-TV: Savannah, Beaufort, SC, News, Weather & Sports

FDA approves artificial iris

The prosthetic was approved for adults and children with missing or damages irises. (Source: Pixabay) The prosthetic was approved for adults and children with missing or damages irises. (Source: Pixabay)

(RNN) – The U.S. Food and Drug Administration announced Wednesday that it's approved the first standalone prosthetic iris in the United States.

The surgically implanted device, called the CustomFlex Artificial Iris, was approved for adults and children with a missing or damaged iris, the colored area around the pupil that controls the amount of light entering the eye.

"Today's approval of the first 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,” said Malvina Eydelman, M.D., director of the Division of Ophthalmic, and Ear, Nose and Throat Devices at the FDA's Center for Devices and Radiological Health.

The FDA defines aniridia as "a rare genetic disorder in which the iris is completely or partially absent." The condition affects around 1 in 50,000 to 100,000 people in the U.S.

The CustomFlex Artificial Iris is made from "thin, foldable medical-grade silicone and is custom-sized and colored for each individual patient," and is "held in place by the anatomical structures of the eye or, if needed, by sutures."

Copyright 2018 Raycom News Network. All rights reserved.

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