FDA approves first prosthetic iris

27 Jun 2018

The Food and Drug Administration (FDA) has cleared the CustomFlex Artificial in the US, a prosthetic iris that is surgically implanted to treat adults and children whose iris is damaged or missing due to aniridia (a congenital condition) or other damages to the area.

It is the first of its kind to ever be FDA cleared. The device is made of thin, foldable medical grade silicone and is customised for each patient.

Director of the division of ophthalmic, and ear, nose and throat devices at the FDA's Center for Devices and Radiological Health, Dr Malvina Eydelman said, “The approval of the first artificial iris provides a novel method to treat iris defects that reduces sensitivity to bright light and glare. It also improves the cosmetic appearance of the eye in patients with aniridia.”

The CustomFlex Artificial was also part of a clinical trial of 389 adults and children with aniridia or other iris defects. Overall, more than 70% of patients reported significant decreases in light sensitivity and glare and an improvement in health-related quality of life following the procedure. As well as this, 94% of patients were satisfied with the artificial iris’ appearance.

In a statement released by the FDA, it advises that the CustomFlex Artificial Iris should not be used during pregnancy or in eyes with any of the following conditions: uncontrolled or severe chronic inflammation (uveitis), abnormally small eye size (microphthalmus), untreated retinal detachment, untreated chronic glaucoma, cataract caused by rubella virus, abnormal blood vessels on the iris (rubeosis), certain kinds of damaged blood vessels in the retina, and intraocular infections. 


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