THE SERVICE INSPECTION OF THE DEVICE AND THE EVALUATION OF THE PATIENT PRINTOUTS DID NOT SHOW ANY FINDING, WHICH WOULD HAVE INDICATED A MALFUNCTION. THE MANUFACTURER REVIEWED FURTHER THE LOG FILES FROM THE INSTRUMENT. THE MANUFACTURER SUBSEQUENTLY DISCOVERED THAT UNDER A SPECIFIC CIRCUMSTANCE, THE INITIAL INTRA-OCULAR LENS CALCULATION FOR THE LEFT EYE COULD LEAD TO AN INCORRECT LENS POWER VALUE RECOMMENDATION. THE LENS POWER CALCULATIONS FOR THE RIGHT EYE ARE NOT AFFECTED. THE CALCULATION ISSUE HAPPENS ONLY WHEN THE KERATOMETRY VALUE OF LEFT EYE IS OUT OF THE PERMISSIBLE RANGE OF 26D (DIOPTER) TO 80D OF THE IOLMASTER 500. IN THIS CASE, THE OPERATOR IS INSTRUCTED TO MANUALLY ENTER THE KERATOMETRY VALUES. IF THE HEALTHCARE PROFESSIONAL DOES NOT FOLLOW EXACTLY THE INSTRUCTIONS OF THE PRACTICAL OPERATION GUIDE (1692-983_ADDGA01_US_151110), THE CALCULATION CAN LEAD TO THE ERROR. THE SOFTWARE DEFICIENCY ONLY HAPPENS DURING THE FIRST TIME CALCULATION. ANY FURTHER CALCULATION AFTER RESTARTING THE IOL CALCULATION DIALOGUE WILL DELIVER CORRECT RESULTS FOR THE IOL POWER.
D
Patient 1
THE HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE RESULTS OF TWO INTRA-OCULAR LENS (IOL) POWER CALCULATIONS PERFORMED FOR ONE PATIENT'S LEFT EYE WERE DIFFERENT. THE RECOMMENDED LENS POWER VALUES WERE ALL NEGATIVE THE FIRST DAY AND WHEN RE-DOING THE CALCULATION THE FOLLOWING DAY, THE LENS POWER VALUES HAD THE SAME MAGNITUDE AS THE PRIOR DAY, BUT WERE ALL POSITIVE. THE OPERATOR HAD ENTERED MANUALLY THE KERATOMETRY VALUES FOR PATIENT'S RIGHT AND LEFT EYE. THIS A NORMAL PROCESS FOR PATIENTS, WHO HAVE AN IRREGULAR CORNEA LIKE THIS PATIENT WITH HAVING A POST PKP/CORNEAL TRANSPLANT. THE IOLMASTER 500 WAS USED FOR BOTH IOL CALCULATIONS.