‘CustomFlex Artificial Iris’ Approved By the FDA: It Corrects Vision and Changes Eye Color


A device that replaces the iris through a surgical intervention has just been approved by the U.S. Food and Drug Administration. It’s called the “CustomFlex Artificial Iris,” and the company that received the approval is Clinical Research Consultants, Inc.

The artificial iris has two uses. One of them is to correct vision problems like irises affected by melanomas, birth defects, injuries or people born with albinism that have issues with the irises. The other use is cosmetic, as the artificial iris can come in different colors and it can also repair obvious eye damage.

A New Method to Treat Iris Defects and Improve Cosmetic Appearance

This is where the director of the Division of Ophthalmic, and Ear, Nose and Throat Devices (Center for Devices and Radiological Health, FDA), Malvinas Eydelman comes to clarify the main purpose of the new device:

”Patients with iris defects may experience severe vision problems, as well as dissatisfaction with the appearance of their eye. Today’s approval of the first artificial iris provides a novel method to treat iris defects, by reducing sensitivity to bright light and glare. It also improves the cosmetic appearance of the eye in patients with aniridia.”

Congenital aniridia is a disorder that affects a person in every 50,000 to 100,000 people in the U.S. The iris can completely or partially be absent in people with this condition.

The artificial iris can be implanted through surgery. Then, the natural structures of the eye should hold it in place. In some cases, it might require stitches.

As for cosmetic use, the artificial iris is made from silicon, and it can have different colors. Not only it can be used to fix vision and structural issues of the eye, but it can also be used for cosmetic purpose.

In clinical tests, 70% of the subjects who were part of the trial. They received the artificial iris and saw a decrease in glare and light sensitivity. The implants had low side effects and some adverse reactions. However, 94% of the participants were happy how the iris looked.

FDA does not recommend the CustomFlex Artificial Iris to patients that have the following health issues: severe chronic inflammation, an abnormal small eye size, chronic glaucoma that is not treated, cataract which was caused by the rubella virus, abnormal or damaged blood vessels on the iris and on the retina, or inner eye infections. The artificial iris is not recommended for pregnant women.


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