The FDA has approved the use of “Artificial Iris” in adults and children whose iris have been damaged due to congenital aniridia, trauma, injury, surgical removal of melanoma or albinism. The artificial iris can be colored and sized depending on patient’s needs and is made from a thin, foldable, medical-grade silicone. Iris defects can cause severe vision problems and can also change the normal appearance of the eye. The FDA approved artificial iris can help protect the eyes from bright light and glare and can also improve the appearance of the eye.
It had been given a “breakthrough device designation” and had been approved through a “pre-market approval application”. The safety and effectiveness of the artificial iris were tested in a randomized clinical trial which was conducted on 389 adult and pediatric patients suffering from congenital aniridia. Congenital aniridia, a rare genetic…
