First artificial iris approved by FDA

The first stand-alone prosthetic iris has been approved by the United States Food and Drug Administration.

The device will be surgically implanted to treat adults and children whose iris is completely missing or who suffer from aniridia or who have suffered some other damage to the eye.

Severe vision problems may be the end result for people who suffer from iris defects. In addition, patients may be self-conscious about the appearance of their eye. The artificial iris will help reduce sensitivity to bright light and glare and improves the appearance of the eye for aniridia patients. Anridia leaves the patient with an iris that is partially or completely absent.

The artificial iris known as CustomFlex Artificial Iris is made of thin, foldable medical-grade silicone. The device can be custom-sized and colored for each patient. Using a small incision, the surgeon inserts the device, unfolds it and then evens out the edges and it is held in place by either the structure of the eye or, in some cases, with stitches.*

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