US FDA Approves First Artificial Iris

June 1, 2018: By Jon Swedien
The HumanOptics CustomFlex artificial iris is custom designed to match the patient's natural iris color.

The HumanOptics CustomFlex Artificial Iris is custom designed to match the patient’s natural iris color.

The US FDA has approved the first stand-alone prosthetic iris in the US, the agency announced May 30.

The prosthetic iris is a surgically implanted device, which manufacturer HumanOptics of Germany has dubbed the CustomFlex Artificial Iris.

The device is designed to treat adults and children with irises that are missing or damaged due to a congenital condition called aniridia, the FDA said.

The CustomFlex also is indicated to treat iris defects due to other conditions, such as albinism, traumatic injury, or surgical removal due to melanoma.

The device is made of thin, foldable medical-grade silicone and is custom-sized and colored for each patient, the FDA said.

A surgeon implants the device by making a small incision, inserting the device, unfolding it, and smoothing out the edges using surgical instruments. The prosthetic iris is held in place by the anatomical structures of the eye or, if needed, by sutures, the agency said.

More than 70 percent of patients reported significant decreases in light sensitivity and glare, as well as an improvement in their health-related quality of life following the procedure during a non-randomized clinical trial of 389 adult and pediatric patients with aniridia or other iris defects, the FDA said.

The agency also said 94 percent of patients were satisfied with the artificial iris’ appearance. The study found low rates of adverse events associated with the device or the surgical procedure.

The CustomFlex Artificial Iris was approved through a premarket approval application.

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