On May 30, 2018, the Food and Drug Administration announced the approval of the CustomFlex Artificial Iris. According to the FDA, this is the first approved artificial iris. The approval was granted to Clinical Research Consultants, Inc., and the device is marketed and developed by HumanOptics AG.
The HumanOptics website describes the CustomFlex Artificial Iris as a prosthetic iris used to treat adults and children whose iris is completely or partially missing due to congenital or traumatic aniridia, or other conditions with iris defects. Patients with aniridia experience compromised vision and also suffer from aesthetic defects of the eye. As stated by Dr. Malvina Eydelman, the approval of the CustomFlex Artificial Iris:
provides a novel method to treat iris defects that reduces sensitivity to bright light and glare. It also improves the cosmetic appearance of the eye in patients with aniridia.
HumanOptics website notes that the CustomFlex Artificial Iris is made of pigmented silicone, and is customizable in size and coloration to fir the needs of each individual patient. It further describes that the artificial iris is inserted into the eye by making a small incision and inserting the folded iris into position, the iris is then unfolded and held in place by the structures of the eye, or by sutures, and mimics the function of the natural iris.
Approval of the CustomFlex Artificial Iris was performed under the compassionate use exemptions of the FDA. The approval proceeded through the premarket approval application (PMA). PMA is the FDA review of Class III medical devices, which include high-risk medical devices. Because the CustomFlex Artificial Iris was classified as a high-risk medical device according to the FDA, it required a PMA pathway in order to obtain marketing approval. This is the most stringent type of device marketing under the FDA, and according to the FDA, approval indicates that the CustomFlex Artificial Iris was shown as safe and effective for its intended uses. In addition, the CustomFlex Artificial Iris was granted Breakthrough Device designation. This program is intended to help patients have more timely access to breakthrough technologies that provide treatment for diseases for which no approved treatment exists or which offer significant advantages over existing treatments.