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# FDA Approves HumanOptics’ Artificial Iris
- URL: https://www.fdaweb.com/fda-approves-humanoptics-artificial-iris/
- Published: 2018-05-30T12:00:00.000Z
- Updated: 2026-09-15T00:08:59.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5141567

FDA has approved HumanOptics’ CustomFlex artificial iris, the first standalone prosthetic iris in the U.S. An agency [news release](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm609291.htm?ref=fdaweb.com) says the surgically implanted device treats adults and children whose iris is completely missing or damaged due to aniridia or other damage to the eye. The CustomFlex product is made of thin, foldable medical-grade silicone and is custom-sized and colored for each patient. Its safety and effectiveness were demonstrated in a non-randomized clinical trial of 389 adult and pediatric patients with aniridia or other iris defects. The device was approved through a PMA and had been granted a breakthrough device designation.