FDA Approves First Prosthetic Iris in the U.S.

On Wednesday, the  U.S. Food and Drug Administration approved of the first “stand-alone prosthetic iris”  in the United States. The device is said to help patients with eye and sight damage.

The device is called the CustomFlex Artificial Iris, and it is supposed to help any individual whose iris has been damaged, or is missing completely. The damage might be caused by aniridia, a congenital condition which causes high sensitivity to light and severe vision problems.

Director of the Division of Ophthalmic, and Ear, Nose and Throat Devices at the FDA’s Center for Devices and Radiological Health Malvina Eydelman, M.D., addressed the recent approval of the device. She stated: “Patients with iris defects may experience severe vision problems, as well as dissatisfaction with the appearance of their eye. 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.”

Congenital aniridia is quite rare, affecting one in 50,000 to 100,000 people in the United States.  The disease is strongly related to deterioration of the iris, which causes light to come unfiltered into the eye.  The CustomFlex Artificial Iris can prevent this, and can be implemented in their eyes through surgery and held by the patients’ eye structure.  It is composed of foldable medical-grade silicon  and customized in regards to size and color for each patient.

The device was tested in a study of 400 test subjects with aniridia, both adults and children.  Seventy percent of participants reported a decrease in light sensitivity and an improvement in their daily health. According to the FDA, almost all of the patients were pleased with the physical appearance of the device.

Very few patients reported any side effects. On the FDA’s report, some of the side effects were described:

The study found low rates of adverse events associated with the device or the surgical procedure. In the study, complications associated with the use of the CustomFlex Artificial Iris device included: device movement or dislocation, strands of device fiber in the eye, increased intraocular pressure, inflammation of the iris (iritis), adhesion of the iris to the cornea or lens (synechiae) and the need for secondary surgery to reposition, remove or replace the device. “

When it comes to problems regarding the surgical procedure, increased intra-ocular pressure, blood leakage in the eye and retinal detachment have been noted as possible (yet rare) complications.

The FDA also stated which patients should not use the device.  It stated that the device “should not be used, in eyes with any of the following conditions: uncontrolled or severe chronic inflammation (uveitis), abnormally small eye size (microphthalmus), untreated retinal detachment, untreated chronic glaucoma, cataract caused by rubella virus, abnormal blood vessels on the iris (rubeosis), certain kinds of damaged blood vessels in the retina, and intraocular infections.”

The device has received a premarket approval application (PMA). A PMA confirmation is given to any product that is proven to be effective and safe based on the evidence presented to the FDA.

Featured Image via: Flickr/Andy Rogers