FDA Approves First Artificial Iris for Use in The U.S.


The USFDA (United States Food and Drug Administration) approved the first stand-alone prosthetic iris, a surgically implanted device to treat adults and children whose iris (the colored part of the eye around the pupil) is completely missing or damaged due to a congenital condition called aniridia or other damage to the eye.

Congenital aniridia is a rare genetic disorder in which the iris is completely or partially damaged. It affects approximately 1 in 50,000 to 100,000 people in the U.S. The amount of light entering the eye is controlled by the iris and people with aniridia are light sensitive and also have other severe problems. This CustomFlex Artificial Iris is also indicated to treat iris defects due to other reasons such as albinism, traumatic injury or surgical removal due to melanoma.

“Patients with iris defects may experience severe vision problems, as well as dissatisfaction with the appearance of their eye,” 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. “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.”

The CustomFlex Artificial Iris is made of thin, medical-grade silicone that is foldable and is custom-sized and colored for each individual patient. A surgeon makes a small incision, the device inserted under the incision, unfolds it and smooths out the edges with the help of surgical instruments. The prosthetic iris is held in place by the anatomical structures of the eye or, if needed, by sutures.

In a non-randomized clinical trial of 389 adult and pediatric patients suffering from aniridia or other iris defects, the safety and effectiveness of the CustomFlex Artificial Iris were demonstrated. Following the procedure, more than 70% of patients reported significant decreases in light sensitivity and glare as well as an improvement in health-related quality of life.  In addition, 94% of patients were satisfied with the artificial iris’ appearance.

The CustomFlex Artificial Iris was approved through a premarket approval application (PMA). It was granted Breakthrough Device designation. Finally, the CustomFlex Artificial Iris was granted approval from FDA to Clinical Research Consultants, Inc..