The US Food and Drug Administration (FDA) has approved the first artificial iris for use in adults and children with congenital aniridia or iris defects due to other reasons or conditions, such as albinism, traumatic injury, or surgical removal due to melanoma

The CustomFlex Artificial Iris (HumanOptics AG) is a surgically implanted device made of thin, foldable, medical-grade silicone and is custom-sized and colored for each individual patient. The prosthetic iris is held in place by the anatomical structures of the eye or, if needed, by sutures.

"Patients with iris defects may experience severe vision problems, as well as dissatisfaction with the appearance of their eye," Malvina Eydelman, MD, 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 news release.

"Today's approval of the first artificial iris provides a novel method to treat iris defects that reduce sensitivity to bright light and glare. It also improves the cosmetic appearance of the eye in patients with aniridia," Eydelman said.

Congenital aniridia, a rare genetic disorder in which the iris is completely or partially absent, affects about 1 in 50,000 to 100,000 people in the United States.

The safety and effectiveness of the CustomFlex Artificial Iris were shown primarily in a nonrandomized clinical trial of 389 adult and pediatric patients with aniridia or other iris defects.

More than 70% of patients reported a significant decrease in light sensitivity and glare as well as an improvement in health-related quality of life following implantation of the device. In addition, 94% of patients were satisfied with the artificial iris' appearance, according to the FDA.

Low rates of adverse events associated with the device and surgical procedure

Complications associated with the CustomFlex Artificial Iris included device movement or dislocation, strands of device fiber in the eye, increased intraocular pressure, iritis, adhesion of the iris to the cornea or lens, and the need for secondary surgery to reposition, remove, or replace the device.

Complications associated with the implant procedure included increased intraocular pressure, blood leakage in the eye, cystoid macular edema, secondary surgery, corneal swelling, iritis, and retinal detachment.

The CustomFlex Artificial Iris should not be used in eyes with uncontrolled or severe chronic uveitis, microphthalmus, untreated retinal detachment, untreated chronic glaucoma, cataract caused by rubella virus, rubeosis, certain kinds of damaged blood vessels in the retina, or intraocular infections. It is also contraindicated in patients who are pregnant.

The CustomFlex Artificial Iris had breakthrough device designation and was approved through a premarket approval application, which is the most stringent type of device marketing application and generally required for high-risk devices.