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FDA approves first artificial iris
Source: VEO Ophthalmics, LLC
The U.S. Food and Drug Administration has announced its approval of the first stand-alone prosthetic iris in the United States that could help patients with certain types of eye damage see clearly and improve their appearance.
The surgically implanted device, called the CustomFlex Artificial Iris, is meant to treat adults and children whose iris — the part of the eye that is colored around the pupil — is damaged. Such damage may be caused by a congenital condition called aniridia, in which people are born with a partial or missing iris, or it could happen later in life from a traumatic injury or surgical removal due to melanoma. People born with albinism may also have eye problems that could be corrected with the device.
'Patients with iris defects may experience severe vision problems, as well as dissatisfaction with the appearance of their eye,' Malvina Eydelman, M.D., director of the Division of Ophthalmic, and Ear, Nose and Throat Devices at the FDA's Center for Devices and Radiological Health, said in a statement on Wednesday. 'Today's 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.'
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