Description of Event or Problem · 1
ON (B)(6), I HAD A CRYSTALENS IOL INSERTED DURING CATARACT SURGERY ON MY LEFT EYE. ACCORDING TO THE LITERATURE I WAS GIVEN, THIS IOL IS FDA APPROVED. I (B)(6) - TO HAVE THIS LENS WHICH IT CLAIMED WOULD GIVE ME GOOD CLOSE-UP, MID-RANGE, AND DISTANCE VISION WITH MINIMAL GLARE. IT HAS BEEN 9 WEEKS NOW AND THE SURGEON REPORTS ALL IS FINE WITH THE IMPLANTED LENS, NO SCAR TISSUE. MY CLOSE-UP AND MID-RANGE VISION ARE SATISFACTORY, BUT MY DISTANCE VISION IS ABYSMAL. I CANNOT SEE THE BIG E ON THE EYE CHART CLEARLY. IF THE SURGERY WENT WELL, I HAVE HEALTHY EYES, THEN THE ONLY REASON I CAN FIND FOR TERRIBLE DISTANCE VISION IS THE NEW LENS. I THINK THAT THE CLAIMS MADE WERE LESS THAN HONEST. I WONDER IF THE FDA ASKS PATIENTS FOR THEIR FEEDBACK ON CRYSTALENS IMPLANTS AND OTHERS, OF COURSE. THAT WOULD BE THE TRUE TEST OF WHETHER THIS IOL IS AS EFFECTIVE AS IT PURPORTS TO BE. MY DOCTOR SAID THAT HE HAS A 99% SUCCESS RATE WITH CATARACT SURGERY. NOW I WONDER WHAT HE WAS MEASURING: HOW MANY PATIENTS DIED, HOW MANY LENSES WERE SUCCESSFULLY IMPLANTED, WHETHER THE LENSES ACTUALLY DELIVERED ON THE PROMISES MADE. SINCE TRUTH IN ADVERTISING IS A CATCH-PHRASE WITH THE FDA RECENTLY, I WOULD APPRECIATE IF THE AGENCY WOULD LOOK INTO THE ACTUAL RESULTS PATIENTS HAVE EXPERIENCED WITH THE CRYSTALENS VERSUS THE CLAIMS THE COMPANY MAKES, USING FDA APPROVAL AS AN ENDORSEMENT OF SORTS. DATES OF USE: (B)(6) 2010 -- (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: CATARACT SURGERY.