BRIGHT OCULAR ARTIFICIAL IRIS

Description of Event or Problem

THE BRIGHT OCULAR COSMETIC ARTIFICIAL IRIS IS MANUFACTURED BY A COMPANY IN THE USA, BUT NOT USA APPROVED (ALTHOUGH THE PRODUCT WEBSITE IS VERY MISLEADING IN CLAIMING THAT THE DEVICE IS "MADE FROM FDA APPROVED MATERIALS"). PT MUST TRAVEL TO (B)(6) FOR THESE DEVICES TO BE IMPLANTED. HOWEVER, PTS ARE QUICKLY SENT BACK TO THE US AFTER SURGERY AND MANY PTS EXPERIENCE SEVERE COMPLICATIONS ASSOCIATED WITH THIS DEVICE. THE CURRENT PT PREDICTABLY SUFFERED CORNEAL DECOMPENSATION, IRITIS, GLAUCOMA, AND CATARACT AFTER HAVING A BRIGHT OCULAR ARTIFICIAL IRIS PLACED TO CHANGE HIS EYE COLOR. HIS SURGERY WAS DONE IN (B)(6). THE PT REQUIRED EXPLANT OF THE DEVICE IN BOTH EYES. IN THE RIGHT HE HAS REQUIRED, CATARACT SURGERY, IRIS REPAIR, AND CORNEAL TRANSPLANTATION. THE LEFT EYE MAY NEED FURTHER SURGERY IN THE FUTURE FOR SIMILAR PROBLEMS. THE FDA SHOULD CONSIDER A STRONGLY WORDED WARNING REGARDING MEDICAL TOURISM FOR THE IMPLANTATION OF THESE DANGEROUS COSMETIC ARTIFICIAL IRIS IMPLANTS.