The first artificial iris to replace the colored section of the eye that surrounds the pupil has been approved by the U.S. Food and Drug Administration.
Many people who are candidates for the device were born with a condition called aniridia, a rare genetic disorder in which the iris is missing or damaged. The condition affects 1 in 50,000 to 100,000 people in the United States, the FDA said Wednesday in a news release.
The iris controls the amount of light that enters the eye. If the iris is missing or damaged, it can lead to severe sensitivity to light and other sight problems, the agency said.
The CustomFlex Artificial Iris is custom-colored and molded for each user from medical-grade silicone. The device was evaluated in clinical trials involving almost 400 adults and children. More than 70 percent of users reported decreased light sensitivity and glare, and 94 percent of users were satisfied with the device's appearance, the FDA said.
The most common side effects included device movement or dislocation, increased pressure in the eye, inflammation and the need for additional surgery to reposition, remove or replace the device.
The device isn't recommended for pregnant women or for people with a host of medical conditions affecting the eye, the agency said.
The CustomFlex Artificial Iris is produced by the German firm HumanOptics AG.
Visit the FDA to learn more.
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