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FDA Approves New Iris Replacement Device

FDA Approves New Iris Replacement Device

The United States Food and Drug Administration (FDA) recently approved a new iris replacement device that is surgically implanted in the individual’s eye. The device is called CustomFlex Artificial Iris, which was created by Clinical Research Consultants, Inc. There are two primary uses for CustomFlex Artificial Iris, which include simply changing your eye color and repairing obvious eye damage. By obvious eye damage, this means vision related issues caused by birth defects, traumatic injury, and melanomas that affect the iris and its function.

Individuals who are born with albinism struggle with issues in their irises, and this CustomFlex Artificial Iris can help correct that. Another condition that CustomFlex Artificial Iris can help would be Aniridia. This is a condition where the individual is born with either a partial or missing iris. It affects 1 and every 50,000 to 100,000 people. CustomFlex Artificial Iris is surgically inserted in the individual and held in place by their eye’s natural structures. If the individual is seeking a just a change in eye color, the device can be colored due to the silicon makeup.

So far, 70 percent of the participants in trials have shown measurable decreases in glare and light sensitivity. The side effects have been low as well as negative reactions. 94 percent of participants were satisfied with the artificial iris. Clinical Research Consultants, Inc is excited with the results and the opportunities CustomFlex Artificial Iris will create.

http://bigthink.com/brandon-weber/the-artificial-iris-has-now-been-approved-by-the-fda-heres-what-it-can-do?utm_source=Daily+Newsletter&utm_campaign=666c320739-EMAIL_CAMPAIGN_2018_06_03_04_37&utm_medium=email&utm_term=0_45b26faecc-666c320739-43889085

https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm609730.htm

https://www.healio.com/ophthalmology/ophthalmic-business/news/online/%7B1460e319-5f3b-4bf3-a073-750301fe1056%7D/fda-approves-customflex-artificial-iris

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Posted on

June 8, 2018