First Artificial Iris Approved By FDA

Last Wednesday, the U.S. Food and Drug Administration (FDA), approved the first artificial iris.

Iris is the colored part of the eye that surrounds the pupil.

The surgically implanted device can be used on adults and children. Those whose iris is missing, damaged by a congenital condition called aniridia, or has been injured, can benefit from this device, the agency stated in a news release.

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Dr. Malvina Eydelman, who directs the division of ophthalmic, and ear, nose and throat devices at the FDA’s Center for Devices and Radiological Health said:

“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 that reduces sensitivity to bright light and glare. It also improves the cosmetic appearance of the eye in patients with aniridia.”

Aniridia is a rare genetic disorder that leaves the iris completely or partially gone. Since the iris controls the amount of light entering the eye, those with aniridia are sensitive to light and have other severe vision problems.

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According to the FDA, the CustomFlex Artificial Iris can also be used to treat iris defects due to conditions such as traumatic injury, albinism, or surgical removal due to melanoma.

The artificial iris is made of thin, foldable silicone and is custom-fitted and colored for each patient. To insert the device, a surgeon makes a small incision, places the device under the incision, then unfolds it and even out the edges using surgical instruments.

The safety and effectiveness of the CustomFlex Artificial Iris was primarily shown in a non-randomized clinical trial of 389 adult and pediatric patients with aniridia or other iris defects.

More than 70 percent of these patients said they experienced substantial decreases in light sensitivity and glare, as well as an improvement in quality of life. Ninety-four percent of the patients said they were pleased with the device’s appearance, the FDA added.

The CustomFlex Artificial Iris is solely marketed by HumanOptics AG, in Erlangen, Germany.


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