FDA approves CustomFlex Artificial Iris to treat congenital aniridia- Human Optics AG.

The FDA has approved the first stand-alone prosthetic iris in the United States, a surgically implanted device to treat adults and children whose iris (the colored part of the eye around the pupil) is completely missing or damaged due to a congenital condition called aniridia or other damage to the eye. The CustomFlex Artificial Iris from HumanOptics AG was approved through a premarket approval application (PMA), which is the most stringent type of device marketing application and generally required for high-risk devices. A PMA approval is primarily based on a determination by the FDA that the PMA contains sufficient valid scientific evidence that provides reasonable assurance that the device is safe and effective for its intended uses.

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.