HumanOptics’ artificial iris cleared in USJuly 17, 2018
Astand-alone prosthetic iris has been approved in the United States to treat adults and children whose irides are damaged or missing due to trauma or congenital conditions like aniridia.
The CustomFlex Artificial Iris is made of thin, foldable, medical-grade silicone and is custom-sized and colored for each individual patient. A surgeon makes a small incision, inserts the device under the incision, unfolds it and smooths 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 safety and effectiveness of the CustomFlex Artificial Iris was demonstrated primarily in a non-randomised clinical trial of 389 adult and pediatric patients with aniridia or other iris defects. The FDA granted approval of the CustomFlex Artificial Iris to HumanOptics AG.
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.