The U.S. Food and Drug Administration approved HumanOptics AG's CustomFlex Artificial Iris, making it the first artificial iris in the U.S. which can be surgically implanted in the eye.
Iris, the colored part of the eye around the pupil, controls the amount of light entering the eye and its defects may lead to severe vision problems, as well as dissatisfaction with the appearance of the eye.
CustomFlex Artificial Iris is indicated to treat patients with missing or damaged iris due to a certain eye disease called congenital aniridia or other types of damages. Congenital aniridia is a rare genetic disorder in which the iris is completely or partially absent and affects about 1 in 50,000 to 100,000 people in the U.S.
The device is also approved to treat iris defects due to conditions, such as traumatic injury, surgical removal due to melanoma, or albinism — characterized by little or no color in the eye. The device was approved through a premarket approval application, which is generally used to review high-risk devices.
The CustomFlex Artificial Iris is made of thin medical-grade silicone and can be inserted by a surgeon by making a small incision in the eye.
Erlangen, Germany-based HumanOptics is a unit of Swiss artificial lens maker Medipart AG.
