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News From the Food and Drug Administration
July 3, 2018

First Artificial Iris Ok’d

JAMA. 2018;320(1):23. doi:10.1001/jama.2018.8563

A recently approved prosthetic iris is the first device of its kind to get the FDA’s go-ahead to treat patients with impaired vision from a missing or damaged iris.

The device is indicated for children and adults with the rare genetic disorder aniridia or iris damage from other causes such as albinism, traumatic injury, or surgical removal due to melanoma. Aniridia, in which the iris is partially or completely missing, affects about 1 in 50 000 to 100 000 people in the United States.

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