First Artificial Iris Approved

Brandon D. Ayres, MD


July 10, 2018

Editorial Collaboration

Medscape &

Editor's Note: This video first appeared on the Wills Eye Hospital website and is being republished on Medscape with permission.

Hello. I am Brandon Ayres from the Cornea Service at Wills Eye Hospital in Philadelphia, speaking to you from the Alumni Society Newsroom.

I have exciting news that has been years and years in the making, following a lot of work from several surgeons across the country. We now have approval from the US Food and Drug Administration (FDA) for the HumanOptics CustomFlex artificial iris.[1]

This [artificial iris] is the first and only iris prosthesis approved in the United States. The custom-made prosthesis is indicated for people with complaints of glare and who have symptomatic iris defects because of traumatic injuries, surgical injuries, or aniridia.

The device is very simple. It is a silicone prosthesis, 12.8 mm in width, and a fixed pupil of 3.35 mm.

In patients who complain of glare, we can photograph the unaffected eye, if they have an unaffected eye. In cases of aniridia, patients can choose someone else's iris, but we need a photograph of an iris. That picture is sent off to the company in Germany, where the color and texture of the iris are matched and the prosthesis is fabricated. Then the prosthesis is sent back for implantation in the operating room.

The prosthesis can be placed in the capsular bag, the sulcus, or suture-fixated to the sclera. The procedure can be performed in combination with other surgeries, such as cataract surgery or an implant exchange.

For the first time, we are finally able to offer patients with symptomatic iris injuries a solution to their problems.

Once again, thank you very much. I am Brandon Ayres from the Cornea Service at Wills Eye Hospital, speaking from the Alumni Society Newsroom.