Description of Event or Problem · 1
COMPLAINANT, (B)(6), IS A (B)(6) MALE WHO STATED THAT DUE TO CATARACTS IN BOTH EYES, HE HAD INTRAOCULAR LENS SURGICALLY IMPLANTED IN BOTH EYES. THE SURGERIES WERE PERFORMED AT AN OUTPATIENT SURGICAL CTR IN (B)(6). THE RIGHT EYE WAS OPERATED ON (B)(6) 2007 BUT THE PROCEDURE WAS UNSUCCESSFUL SO HE HAD THE INTRAOCULAR LENS REMOVED ON (B)(6) 2007. HE THEN HAD THE LENS SURGICALLY IMPLANTED IN TO HIS LEFT EYE ON (B)(6) 2007, WHICH DID NOT WORK EITHER. HE HAS NOT HAD THAT LENS REMOVED. COMPLAINANT STATED THAT THE OPERATIONS WERE PERFORMED BY (B)(6), MD AT THE (B)(6) SURGICAL CTR. WHEN ASKED WHAT THE SURGEON TOLD HIM, HE STATED THAT THERE WAS NO GUARANTEE. COMPLAINANT WAS TOLD THAT THE MFR WAS ALCON LABS IN TX AND GIVEN THE NUMBER (B)(4), WHICH HE CALLED AND THEY TOLD HIM THAT THEY WOULD INVESTIGATE AND GET BACK TO HIM. HE STATED HE HAS NOT RECEIVED A CALL BACK. EVEN THOUGH THE COMPLAINANT IS NOT EXPERIENCING ANY PAIN, HE STATED THAT HIS VISION IS RUINED. HE CANNOT SEE WITHOUT USING A PAIR OF GLASSES FOR READING, ANOTHER FOR THE COMPUTER AND ANOTHER FOR EVERYTHING ELSE. HIS NIGHT VISION IS 'HORRIBLE' AND HIS EYES ARE CONSTANTLY DRY. HE USES OTC EYE LUBRICATING DROPS. I ASKED IF THE SURGEON REPORTED THIS INCIDENT TO MEDWATCH AND HE STATED HE DID NOT KNOW. I ASKED IF FDA NEEDED TO OBTAIN HIS MEDICAL RECORDS CONCERNING THIS INCIDENT WOULD HE BE WILLING TO ALLOW HIS MEDICAL RECORDS TO BE RELEASED AND HE STATED YES HE WOULD. HE ALSO STATED THAT HE HAS TRIED TO HIRE SEVERAL LAWYERS BUT NO ONE WILL TAKE HIS CASE.