CustomFlex artificial iris
Clinical Research Consultants and HumanOptics AG
HumanOptics’s artificial iris is a foldable iris prosthesis for medical and aesthetic reconstruction of eyes with complete or partial aniridia, which is the full or partial absence of the colored part of the eye.
Germany-based HumanOptics designed the injectable device to be individually custom-made to mimic the original appearance of a patient’s iris. It has a controlled light entry with fixed pupil aperture and opaque material.
The FDA first granted pre-market approval and breakthrough device designation for the device in May 2018. CustomFlex was also a nominee of Prix Galien’s best medical technology in 2020.