The CustomFlex Artificial Iris is a prosthetic iris (the colored part of the eye around the pupil) made of thin, foldable medical-grade silicone. This device is custom-made and can be sized and colored for each individual patient. This with Fiber model has a polyester meshwork layer embedded in it to provide adequate tear strength to withstand suturing. The CustomFlex Artificial Iris can be used to treat congenital (genetic disorder in which the iris is completely or partially absent) and traumatic aniridia.It can also be used to treat iris defects due to other reasons or conditions, such as albinism, or surgical removal due to melanoma.
A sterile optical device intended to be implanted into the posterior chamber of the eye for the reconstruction of partial or total iris defects (congenital, traumatic, or degenerative). It may be constructed from a single or multiple component(s) and implanted during cataract surgery, or secondarily into the pseudophakic eye. It is made of synthetic material [e.g., polymethylmethacrylate (PMMA), silicone] and is available in a variety of sizes and/or colours.