The BRIGHTOCULAR implant is a United States invented device made of ophthalmic grade silicone which is used in intraocular lenses for decades throughout the world. BrightOcular is manufactured in France under Class-100 strictly controlled environment. The facility has ISO 13485 certification, which is one of the highest medical device manufacturing standards in the world.
The BrightOcular procedure is ambulatory, short, safe, and painless. It is performed under topical anesthesia and takes about 15 minutes for each eye. Since the implant is flexible it can be folded and inserted into the eye through a peripheral corneal surgical incision about 2.8 mm long. No corneal sutures are needed for this length of the incision. Anterior chamber intraocular lens implantation and phakic IOL implantation are performed worldwide for years and are also FDA approved techniques (ICL, Cataract Extraction).
