THE MANUFACTURER MADE SEVERAL ATTEMPTS TO DUPLICATE THE REPORTED PROBLEM AS PART OF ITS COMPLAINT INVESTIGATION, BUT WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM. THE IOLMASTER 500 WAS FOUND TO BE WORKING WITHIN SPECIFICATION. AS PART OF THE CONTINUING INVESTIGATION, INSTRUMENT LOG FILES WERE OBTAINED FROM THE SITE. BASED ON A REVIEW OF THE LOG FILES, THE MANUFACTURER SUBSEQUENTLY DETERMINED THAT A SPECIFIC WORKFLOW COULD RESULT IN THE OBSERVED PROBLEM DUE TO A SOFTWARE ANOMALY. A DETERMINATION WAS MADE THAT THIS MALFUNCTION COULD POTENTIALLY LEAD TO THE SELECTION OF A SUB-OPTIMAL IOL IF NOT DETECTED BY THE HEALTHCARE PROVIDER.
D
Patient 1
IT WAS REPORTED THAT DURING A CATARACT CONSULT THE HEALTHCARE PROVIDER DISCOVERED THAT THE IOLMASTER 500 HAD PROVIDED THE WRONG INTRAOCULAR (IOL) CALCULATIONS FOR THE PATIENT WHEN USING THE MULTI-FORMULA FUNCTION. THE HEALTHCARE PROVIDER DETECTED THE ANOMALY BECAUSE THE IOL LENS POWER CALCULATIONS FOR THE TECHNIS ZA9003 LENS WERE IDENTICAL TO THOSE OF THE SOFTPORT L161AO LENS. AS A RESULT, THE HEALTHCARE PROVIDER DID NOT USE THE DATA TO PERFORM IOL IMPLANTATION. WHEN THE PATIENT'S MEASUREMENT DATA WAS RE-RUN AT A LATER TIME USING THE TECHNIS ZA9003 LENS, THE LENS ACHIEVED THE EXPECTED LENS POWER CALCULATIONS.
N
Patient 1
FIELD G5 PMA/510(K) CHANGED FROM K101182 TO K122418 (CORRECTION).