It was shown to be safe and effective in a clinical trial of 389 adults and children with aniridia or other iris defects. HumanOptics has received Food and Drug Administration ( FDA ) approval to market its artificial iris in the US . The German start - up 's device can be used in adults and children whose iris is missing due to injury or rare genetic disorder aniridia , which occurs in about one in 50,000 to 100,000 newborns worldwide . The surgically implanted prosthetic is made of silicone and can be coloured for individual patients . It was found to be safe and effective in a clinical trial of 20 patients .
HumanOptics has received Food and Drug Administration ( FDA ) approval to market its artificial iris in the US . The German start - up 's device can be used in adults and children whose iris is missing due to injury or rare genetic disorder aniridia , which occurs in about one in 50,000 to 100,000 newborns worldwide . The surgically implanted prosthetic is made of silicone and can be coloured for individual patients . It was found to be safe and effective in a clinical trial of 20 patients .