The artificial iris is indicated for vision loss and glare from significant iris defects. It is NOT cosmetic.
The CustomFlex artificial iris was FDA approved in May 2018 for symptoms including light sensitiviy, reading difficulty, difficulty night driving, starbursts, glare and halos due to congenital or acquired iris defects. Dr. Cohen was the first surgeon to implant an artificial iris in Tampa Bay. The iris is custom made to match the fellow eye. It does not react to light but has a fixed pupil size of 3.35 mm which is about the average pupil size. The iris is designed to block incoming light that may be compromising visual function.
The procedure is contraindicated in eyes with uncontrolled inflammation, small eyes, untreated retinal detachment, untreated chronic glaucoma, proliferative diabetic retinopathy and a few other rare eye disorders. It cannot be implanted in an eye with silicone oil. In addition, it would not be helpful to someone with a blind eye. A blind eye can be better treated with a cosmetic contact lens.
This patient had trauma and lost most of his iris and had no lens. This procedure shows the suturing of an Akreos AO60 posterior chamber intraocular lens and an artificial iris. The artificial iris was FDA approved in 2018. It is only indicated for eyes with congenital or acquired iris defects. It is NOT a cosmetic procedure.