The small but underserved population of patients with iris abnormalities now has a new option: a stand-alone prosthetic iris said to be an improvement upon older designs. Previous prostheses have been in effect modified capsular tension rings or intraocular lenses (IOLs) with occluders to mask iris defects. The CustomFlex Artificial Iris, created by Germany-based HumanOptics AG, is said to use a more realistic design and can be modeled on the appearance and size of the fellow eye’s iris. It does not contain an optic, freeing surgeons to pair it with other IOLs as needed.

CustomFlex received FDA approval earlier this week. The surgically implanted device is designed to treat adults and children with a missing or damaged iris from congenital aniridia, albinism, trauma or melanoma surgery. 

More than 70% of patients in the FDA trials reported significant decreases in light sensitivity and glare as well as improved quality of life following the procedure, according to the manufacturer. Contraindictions for the CustomFlex include uncontrolled or severe uveitis, microphthalmus, untreated retinal detachment or chronic glaucoma, cataract caused by rubella virus, rubeosis irides, retina vascular compromise and intraocular infections.

FDA approves first artificial iris. US Food & Drug Administration. May 30, 2018. Available at Accessed June 1, 2018.