Clinical Research Consultants’ CustomFlex Artificial Iris is a surgically implanted device for patients whose iris is missing or damaged.
The artificial iris is comprised of a thin, foldable silicone material, which can be customized and color-matched to each patient’s eyes.
Surgeons insert the iris via a small incision in the eye, and the eye’s anatomical structures hold the iris in place.
“Patients with iris defects may experience severe vision problems, as well as dissatisfaction with the appearance of their eye,” said Malvina Eydelman, MD, director of the division of ophthalmic and ENT 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 reduce sensitivity to bright light and glare.”
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