Cosmetic iris implants have not been evaluated by any U.S. regulatory agency or tested for safety in clinical trials. While the implants are not approved by the U.S. Food and Drug Administration, it has been reported in the media this month that the surgery is being performed overseas. During iris implant surgery, an artificial iris made of silicone is folded and inserted into a slit that has been cut into the cornea. Then the iris is unfolded and adjusted to cover the natural iris. Local anesthesia is used.