AS A THRESHOLD MATTER, MORIA DOES NOT BELIEVE THAT THESE INCIDENTS WERE OR ARE REPORTABLE, AS THE EVOLUTION 3 CONSOLE DEVICE IS NOT USED DIRECTLY ON PTS. RATHER IT IS USED TO CUT TISSUE FROM DONOR EYES FOR USE IN CORNEAL TRANSPLANTS. IF THE TISSUE SPECIMEN IS FLAWED IN ANY WAY, THE PHYSICIAN SHOULD NOT PROCEED WITH THE TRANSPLANT PROCEDURE. THEREFORE, THERE SHOULD BE NO RISK TO PTS FROM AN IMPERFECT CUT OF DONOR TISSUE. IT IS UNCLEAR WHY THE PHYSICIAN PERFORMED SURGERY WITH IMPERFECT SPECIMENS IN THIS CASE. THAT SAID, MORIA HAS CONDUCTED A THOROUGH REVIEW AND INVESTIGATION OF THE MEDWATCH REPORTS FILED BY (B) (6) HOSPITAL, AND HEREBY SUBMITS THIS RESPONSE. THIS MEDICAL DEVICE REPORT IS WRITTEN IN RESPONSE TO TWO MEDWATCH REPORTS FILED BY (B) (6) HOSPITAL IN (B) (6) (UF/IMPORTER REPORT (B) (4)). MORIA RECEIVED COPIES OF THESE REPORTS ON 04/03/2009. THE REPORTS STATE IN BOTH CASES, THE PHYSICIAN DECIDED TO CONTINUE WITH THE PROCEDURE AND IMPLANT THE IMPERFECTLY-CUT TISSUE INTO EACH PT'S OPERATIVE EYE. ACCORDING TO (B) (6) HOSPITAL, BOTH PTS REQUIRED A SECOND DSAEK PROCEDURE TO REPLACE THE IMPLANTED CORNEAL TISSUE WITH PRE-CUT, EYE BANK TISSUE AND ARE NOW DOING WELL. (B) (6) HOSPITAL RETURNED TURBINE # (B) (4), THE TURBINE INVOLVED IN BOTH INCIDENTS, TO MORIA FOR EVAL. THE HOSPITAL DID NOT, HOWEVER, SAVE AND RETURN THE MICROKERATOME BLADE(S) USED IN THE INCIDENTS. MORIA'S INSPECTION OF THE EQUIPMENT REVEALS THAT THERE WAS A MICROSCOPIC IMPERFECTION IN THE THREADS ON THE BACK OF THE TURBINE, WHICH LED TO AN INSECURE CONNECTION BETWEEN THE TURBINE AND THE TURBINE HOSE, LEADING TO A LOSS OF POWER THAT ADVERSELY AFFECTED THE QUALITY OF THE CORNEAL CUT. FURTHER EVAL OF A "CONTROL" TURBINE HOSE CONFIRMED THAT THE THREADING IMPERFECTION WAS AN ISSUE ONLY WITH THE PARTICULAR HOSE USED IN THE TWO INCIDENTS, AND IS NOT A PROBLEM FOR OTHER HOSES TESTED ON THIS MACHINE. IT IS POSSIBLE THAT DAMAGE TO THE THREADING OCCURRED EITHER DURING THE SHIPPING PROCESS OR IN THE HOSPITAL FACILITY. TO MORIA'S KNOWLEDGE, THE PROBLEM WITH THE THREADING ON THE BACK OF THE LOANER TURBINE, AND (B) (6) HOSPITAL'S EXPERIENCES WITH THE DEVICE, ARE ISOLATED INCIDENTS THAT DO NOT PRESENT QUALITY CONTROL ISSUES. MORIA'S EVAL ALSO STRONGLY SUGGESTS THAT (B) (6) HOSPITAL'S USE OF THE DEVICES DID NOT CONFORM TO PUBLISHED GUIDELINES. AS MORIA'S EVOLUTION 3 INSTRUCTION MANUAL AND (B) (4) USER'S MANUAL STATE, USERS SHOULD CHECK AND CONFIRM HOSE CONNECTIVITY AND PROPER POWER LEVELS PRIOR TO USE, WHICH APPARENTLY WAS NOT DONE IN THESE CASES. THE PHYSICIAN'S DECISION TO CONTINUE WITH SURGERY AND IMPLANT DONOR CORNEAL TISSUE IN BOTH PTS-DESPITE BEING AWARE THAT THE CUT WAS IMPERFECT-IS ALSO NOTABLE.
D
Patient 1
TWO PTS WERE AFFECTED -PTS A AND B.
D
Patient 2
TWO PTS WERE AFFECTED -PTS A AND B.
N
Patient 2
AS A THRESHOLD MATTER, MORIA DOES NOT BELIEVE THAT THESE INCIDENTS WERE OR ARE REPORTABLE, AS THE EVOLUTION 3 CONSOLE DEVICE IS NOT USED DIRECTLY ON PTS. RATHER IT IS USED TO CUT TISSUE FROM DONOR EYES FOR USE IN CORNEAL TRANSPLANTS. IF THE TISSUE SPECIMEN IS FLAWED IN ANY WAY, THE PHYSICIAN SHOULD NOT PROCEED WITH THE TRANSPLANT PROCEDURE. THEREFORE, THERE SHOULD BE NO RISK TO PTS FROM AN IMPERFECT CUT OF DONOR TISSUE. IT IS UNCLEAR WHY THE PHYSICIAN PERFORMED SURGERY WITH IMPERFECT SPECIMENS IN THIS CASE. THAT SAID, MORIA HAS CONDUCTED A THOROUGH REVIEW AND INVESTIGATION OF THE MEDWATCH REPORTS FILED BY (B) (6) HOSPITAL, AND HEREBY SUBMITS THIS RESPONSE. THIS MEDICAL DEVICE REPORT IS WRITTEN IN RESPONSE TO TWO MEDWATCH REPORTS FILED BY (B) (6) HOSPITAL IN (B) (6) (UF/IMPORTER REPORT (B) (4)). MORIA RECEIVED COPIES OF THESE REPORTS ON 04/03/2009. THE REPORTS STATE IN BOTH CASES THE PHYSICIAN DECIDED TO CONTINUE WITH THE PROCEDURE AND IMPLANT THE IMPERFECTLY-CUT TISSUE INTO EACH PT'S OPERATIVE EYE. ACCORDING TO (B) (6) HOSPITAL, BOTH PTS REQUIRED A SECOND DSAEK PROCEDURE TO REPLACE THE IMPLANTED CORNEAL TISSUE WITH PRE-CUT, EYE BANK TISSUE AND ARE NOW DOING WELL. (B) (6) HOSPITAL RETURNED TURBINE #(B) (4), THE TURBINE INVOLVED IN BOTH INCIDENTS, TO MORIA FOR EVAL. THE HOSPITAL DID NOT, HOWEVER, SAVE AND RETURN THE MICROKERATOME BLADE(S) USED IN THE INCIDENTS. MORIA'S INSPECTION OF THE EQUIPMENT REVEALS THAT THERE WAS A MICROSCOPIC IMPERFECTION IN THE THREADS ON THE BACK OF THE TURBINE, WHICH LED TO AN INSECURE CONNECTION BETWEEN THE TURBINE AND THE TURBINE HOSE, LEADING TO A LOSS OF POWER THAT ADVERSELY AFFECTED THE QUALITY OF THE CORNEAL CUT. FURTHER EVAL OF A "CONTROL" TURBINE HOSE CONFIRMED THAT THE THREADING IMPERFECTION WAS AN ISSUE ONLY WITH THE PARTICULAR HOSE USED IN THE TWO INCIDENTS, AND IS NOT A PROBLEM FOR OTHER HOSES TESTED ON THIS MACHINE. IT IS POSSIBLE THAT DAMAGE TO THE THREADING OCCURRED EITHER DURING THE SHIPPING PROCESS OR IN THE HOSPITAL FACILITY. TO MORIA'S KNOWLEDGE, THE PROBLEM WITH THE THREADING ON THE BACK OF THE LOANER TURBINE, AND (B) (6) HOSPITAL'S EXPERIENCES WITH THE DEVICE, ARE ISOLATED INCIDENTS THAT DO NOT PRESENT QUALITY CONTROL ISSUES. MORIA'S EVAL ALSO STRONGLY SUGGESTS THAT (B) (6) HOSPITAL'S USE OF THE DEVICES DID NOT CONFORM TO PUBLISHED GUIDELINES. AS MORIA'S EVOLUTION 3 INSTRUCTION MANUAL AND (B) (4) USER'S MANUAL STATE, USERS SHOULD CHECK AND CONFIRM HOSE CONNECTIVITY AND PROPER POWER LEVELS PRIOR TO USE, WHICH APPARENTLY WAS NOT DONE IN THESE CASES. THE PHYSICIAN'S DECISION TO CONTINUE WITH SURGERY AND IMPLANT DONOR CORNEAL TISSUE IN BOTH PTS-DESPITE BEING AWARE THAT THE CUT WAS IMPERFECT-IS ALSO NOTABLE.