Description of Event or Problem · 1
ACCORDING TO THE MEDICAL RECORDS OF THE TREATING SURGEON, THE PT PRESENTED FOR LASIK SURGERY. THE PROCEDURE WENT SMOOTHLY ON THE RIGHT EYE (OD). ON THE LEFT EYE (OS), THE SURGEON HAD DIFFICULTY TRANSITIONING THE KERATOME BLADE THROUGH THE TRACKS OF THE SUCTION RING THAT FITS OVER THE EYE. RATHER THAN STOPPING THE PROCEDURE IMMEDIATELY, THE SURGEON ATTEMPTED TO COMPLETE THE CUTTING OF THE CORNEAL FLAP, RESULTING IN A PARTIAL FREE FLAP. THE FREE FLAP WAS PUT BACK IN PLACE AND A BANDAGE CONTRACT LENS WAS PLACED OVER THE EYE AND ANTIBIOTIC STEROIDS WERE APPLIED. THE TREATING SURGEON REPORTED THAT NINE WEEKS POST-OP THE PT'S BEST CORRECTED VISION (BCV) IN THE LEFT EYE WAS 20/25+ WITH A VERY FAINT PERICENTRAL CORNEAL SCAR. THE TREATING PHYSICIAN INDICATED THAT HE FELT THAT THE PT'S LEFT EYE WOULD COMPLETELY HEAL ITSELF OVER TIME, AND THE PT WOULD STILL BE A GOOD CANDIDATE FOR LASIK SURGERY IN THIS EYE. THE PT WAS SUBSEQUENTLY SEEN BY ANOTHER PHYSICIAN AT ANOTHER EYE CLINIC WHO TWICE RECORDED THE PT'S VISION AS 20/20 BCV IN THE LEFT EYE ON SEPTEMBER 10, 1999 AND AUGUST 1, 2000 RESPECTIVELY. HOWEVER, THE PHYSICIAN ALSO NOTED CORNEAL SCARRING RESULTING IN SOME CORNEAL IRREGULARITY. HE REPORTED THAT THE PT COMPLAINED OF BLURRED VISION AND OCCASIONAL DOUBLE VISION. THE PT WAS FIT WITH A CONTACT LENS TO TREAT MILD ASTIGMATISM AND CORNEAL IRREGULARITY RELATED TO THE SCAR. PT WAS SCHEDULED FOR A FOLLOW-UP APPOINTMENT A WEEK LATER, BUT NEVER RETURNED. THIS IS THE MOST CURRENT INFO IMPORTER HAS ABOUT THE PT'S MEDICAL CONDITION. IMPORTER HAS NO INFO TO CONFIRM OR DENY THAT PT HAS ANY CONTINUING INJURY AT THIS TIME. THIS MATTER FIRST CAME TO IMPORTER'S ATTENTION ON JULY 14, 2000 WHEN THE PT FILED A COMPLAINT IN STATE COURT AGAINST MORIA, MICROTECH, AND THEIR INSURERS, CLAIMING THAT THE MICRPKERATOME CAUSED ALLEGED INJURIES. AT THE TIME, MICROTECH WAS MORIA'S EXCLUSIVE U.S. DISTRIBUTOR. MORIA HAS SINCE ACQUIRED MICROTECH. IMPORTER DID NOT FILE A REPORT AT THE TIME THEY RECEIVED THE PT'S COMPLAINT FOR TWO REASONS. FIRST, INVESTIGATION OF THE INCIDENT AND THE MICROKERATOME IN QUESTION SHOWED THAT THE MACHINE WAS FUNCTIONING PROPERLY AND CONTAINED NO DISCERNIBLE DEFECT OR MALFUNCTION. THE TREATING SURGEON ACKNOWLEDGED THAT THE MICROKERATOME FUNCTIONED PROPERLY ON ALL PTS PRIOR TO THIS PT, AS WELL AS ON THIS PT'S RIGHT EYE. IT ALSO SUBSEQUENTLY PERFORMED PROPERLY ON OTHER PTS THAT SAME DAY IN THE SAME CLINIC AND BY THE SAME DOCTOR. IN ADDITION, IT PERFORMED PROPERLY FOR SEVERAL MONTHS FOLLOWING THE SURGERY IN NUMEROUS PROCEDURES PERFORMED BY THE TREATING SURGEON AND OTHER SURGEONS. NO PROBLEMS OR DEFECTS WERE FOUND WHEN THE MACHINE WAS SENT FOR ROUTINE MAINTENANCE IN THE SUMMER OF 1999. IN FACT, NEITHER THE TREATING PHYSICIAN NOR THE VISION CENTER IN QUESTION EVER MENTIONED THIS INCIDENT OR THAT THERE WAS PROBLEM WITH THE MICROKERATOME. AFTER PERFORMING ROUTINE MAINTENANCE AND CLEANING IN 1999, IMPORTER RETURNED THE MACHINE TO THE VISION CENTER AND RECEIVED NO COMPLAINTS UNTIL THEY RECEIVED SERVICE OF THE PT'S LEGAL ACTION IN JULY 2000. BASED ON THIS INFO, IMPORTER HAS CONCLUDED THAT THE INCIDENT IN QUESTION DID NOT RESULT FROM ANY MACHINE ERROR. RATHER, THIS INCIDENT WAS CAUSED BY THE SURGEON'S HAND POSITIONING OF THE MICROKERATOME HEAD AS IT MOVED THROUGH THE TRACKS OF THE SUCTION RING. THE "LSK ONE" MICROKERATOME IS A MANUAL MICROKERATOME. A SMOOTH TRANSITION OF THE MICROKERATOME HEAD BY THE SURGEON IS ESSENTIAL TO THE PROPER FUNCTIONING OF THE MACHINE. SECOND, WHILE IMPORTER RECOGNIZES THAT USER ERROR IS REPORTABLE IN CASES IN WHICH A "SERIOUS INJURY" RESULTS FROM A PROCEDURE INVOLVING AN APPROVED MEDICAL DEVICE, NO REPORT IS DUE WHERE THERE IS NO "SERIOUS INJURY" AS THAT TERM IS DEFINED IN THE FDA'S REGULATIONS. THE REGULATIONS DEFINE "SERIOUS INJURY" TO MEAN, IN PERTINENT PART, AN INJURY OR ILLNESS THAT RESULTS IN PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE OR THAT REQUIRES MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH PERMANENT IMPAIRMENT OR DAMAGE. IN THIS CASE, THE REPORTS AND MEDICAL RECORDS RECEIVED FROM THE TREATING SURGEON INDICATED THAT THE PT WAS EXPECTED TO REGAIN 20/20 BCV WITH NO OTHER VISION PROBLEMS. THE TREATING SURGEON ALSO REPORTED ONLY FAINT SCARRING. IN FACT, AS NOTED ABOVE, THE SURGEON INDICATED THAT HE THOUGHT THE PT WOULD BE A GOOD CANDIDATE FOR FOLLOW-UP LASIK IN THE LEFT EYE. BASED ON CONSULTATIONS WITH FDA STAFF, IMPORTER DETERMINED THAT THEY WERE NOT REQUIRED TO REPORT THIS INCIDENT UNTIL THEY HAD AN OPPORTUNITY TO REVIEW THE PT'S MORE CURRENT MEDICAL RECORDS. IMPORTER RECENTLY RECEIVED SOME OF THOSE RECORDS IN THE FORMAL DISCOVERY PROCESS OF THE PENDING LITIGATION. UPON RECEIPT OF THE MEDICAL RECORDS, IMPORTER PROMPTLY COMMISSIONED AN INDEPENDENT MEDICAL REVIEW. PRELIMINARY RESULTS OF THAT REVIEW RECEIVED ON FEBRUARY 27, 2001, WHICH INDICATED THAT THE PT'S CORNEAL SCARRING MAY BE CAUSING HIM SOME CONTINUED VISION PROBLEMS, ALTHOUGH THAT CONCLUSION IS IMPOSSIBLE TO CONFIRM SINCE THESE TYPES OF SUBJECTIVE COMPLAINTS GENERALLY CANNOT BE OBJECTIVELY EVALUATED, AND BECAUSE THE PT APPARENTLY HAS FAILED TO RETURN FOR FOLLOW-UP EXAMINATION. EVEN THOUGH THE INDEPENDENT REVIEWER BELIEVES THE PT'S ALLEGED ONGOING VISION PROBLEMS COULD STILL CLEAR UP WITH TIME, IMPORTED FELT THAT, OUT OF AN ABUNDANCE OF CAUTION, THEY SHOULD SUBMIT THIS REPORT AT THIS TIME.