The United States Food and Drug Administration has approved the first stand-alone prosthetic iris in the US, a surgically implanted device to treat adults and children whose iris is completely missing or damaged due to a congenital condition aniridia or other damage to the eye.
The device was developed by HumanOptics AG, a medical technology company based in Erlangen, Germany.
“Patients with iris defects may experience severe vision problems, as well as dissatisfaction with the appearance of their eye,” Dr Malvina Eydelman, MD, director of the division of Ophthalmic, and Ear, Nose and Throat Devices at the FDA’s Center for Devices and Radiological Health, said.
‘Novel method to treat iris defects’
“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.”
Congenital aniridia is a rare genetic disorder in which the iris is completely or partially absent. It affects approximately 1 in 50,000 to 100,000 people in the US.
In addition to congenital aniridia, the CustomFlex Artificial Iris is indicated to treat iris defects due to other reasons or conditions, such as albinism, traumatic injury or surgical removal due to melanoma.
The artificial iris is made of thin, foldable medical-grade silicone and
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