Description of Event or Problem · 1
IN 2002, AN ASSOCIATE GENERAL COUNSEL (1) REPRESENTING THE USER FACILITY, REPORTED TO THE MANUFACTURER'S TECHNICAL SUPPORT, STATING THE PATIENT'S PRINTOUT FROM THE TIME OF THEIR EXAM DID NOT MATCH THE PATIENT'S FILE ON THE CTS 990, AND CAUSED THEIR SURGERY TO BE WRONG, SUBSEQUENTLY, ADDITIONAL INFORMATION WAS GIVEN TO THE MANUFACTURER: * THAT THIS PATIENT HAD EYE CORRECTION SURGERY IN 1999. * THAT APPROXIMATELY 2 YEARS FOLLOWING THE SURGERY, THE PATIENT COMPLAINED TO THE USER FACILITY ABOUT THEIR DISSATISFACTION FROM THE SURGERY AND PATIENT ALLEGED AN EYE WAS "BAD" BECAUSE THE EXAM RESULTS PROVIDED WERE NOT THE PATIENT'S. * THAT PATIENT HAD A CORNEAL TRANSPLANT ABOUT 3 MONTHS AGO, BUT THERE WAS NO ADDITIONAL INFORMATION TO CONFIRM IF THE TRANSPLANT WAS DUE TO THE SURGERY. * THE USER FACILITY HAD TAKEN 2 TOPOGRAPHIES BEFORE THE SURGERY AND ONE AFTER. * THAT THE RESULTS WERE PRINTED OUT IN COLOR AND PLACED INTO THE PATIENT'S FILE. SOME TIME LATER, THE PATIENT ASKED FOR A COPY OF THEIR FILE TO GIVE TO ANOTHER DOCTOR FOR A SECOND OPINION ON THEIR SURGERY. * THAT THE USER FACILITY GAVE BLACK AND WHITE COPIES OF THE PATIENT'S FILE TO THEM. PATIENT CAME BACK LATER AS THE PERSON WANTING THE COPIES THEY COULDN'T READ THE BLACK AND WHITE ONES AND WANTED THE COLOR PRINTOUTS INSTEAD. * THAT THE USER FACILITY WAS TOLD THAT THE COLOR COPIES ALLEGEDLY DID NOT MATCH THE BLACK AND WHITE COPIES. * THAT IT ALLEGEDLY APPEARED FROM THE BLACK AND WHITE COPIES (FROM PATIENT HARD COPY FILE) THAT THE PATIENT MAY NOT HAVE NEEDED THE SURGERY AND THAT THE COLOR COPIES (FROM THE INSTRUMENT) BELONGED TO SOMEONE ELSE, AS THEY DID NOT MATCH. * THAT THE USER FACILITY PULLED ALL PATIENTS FILES FROM THE DATE THAT THE PATIENT'S EXAM WAS DONE AND FOUND NONE OF THE TOPOGRAPHIES MATCHED THE HARD COPIES IN THEIR FILES. COMPANY HAVE BEEN UNABLE TO CONFIRM OR VERIFY THAT THERE HAS BEEN AN ACTUAL INJURY.