The Food and Drug Administration has approved the first artificial iris implant in the United States called the CustomFlex Artificial Iris. The implant will benefit patients with missing or damaged irises due to aniridia, traumatic injury, albinism, and melanoma.
The CustomFlex Artificial Iris is produced by the German firm HumanOptics AG. The CustomFlex Artificial Iris will treat adults and children with a missing or damaged iris. It is a permanent implant designed to replace the colored contact lenses currently used by patients with the problem.
“Patients with iris defects may experience severe vision problems, as well as dissatisfaction with the appearance of their eye,” said the FDA’s Dr. Malvina Eydelman. She added that the artificial iris will treat defects that lead to reduced sensitivity to glare and bright lights, and will improve the cosmetic appearance of patients with aniridia.
The CustomFlex Artificial Iris uses this foldable medical-grade silicone, and its size and color are customized for each patient. To implant it, the surgeon will make a small incision on the patient’s eye, insert the artificial iris under the incision, and then unfold it using surgical instruments. The artificial iris will be kept in its place by the eye’s own structures, or by sutures if required.
Missing or partially missing irises are the effect of congenital aniridia, a rare genetic disorder that affects about one in 50,000 to 100,000 people in the United States. The iris controls how much light enters the eye, so people with aniridia are very sensitive to light and suffer from various vision issues.
Studies on the artificial iris implant, however, noted that complications arise when the procedure was performed on people with eyes that have chronic inflammation, abnormally small size, untreated chronic glaucoma, untreated retinal detachment, abnormal or damaged blood vessels on the iris, cataract due to rubella virus, and other infections. The procedure is also not recommended for pregnant women.
It remains to be seen whether people will attempt to undergo the procedure to implant the CustomFlex Artificial Iris purely for cosmetic purposes to change their eye color. However, patients who medically need the implant will likely be prioritized.