BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IOLMASTER 500

    MDR report key: 5149213 · Received October 14, 2015

    Report

    Report Number
    9615030-2015-00007
    Event Type
    Malfunction
    Date Received
    October 14, 2015
    Date of Event
    June 23, 2015
    Report Date
    October 13, 2015
    Manufacturer
    CARL ZEISS MEDITEC AG (JENA)
    Product Code
    HJO
    PMA / PMN Number
    K122418
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    FIELD G5 PMA/510(K) CHANGED FROM K101182 TO K122418 (CORRECTION).

    Description of Event or Problem · 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.

    Description of Event or Problem · 1

    NA

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681096 IOLMASTER 500 BIOMICROSCOPE, SLIT-LAMP, AC-POWERED HJO CARL ZEISS MEDITEC AG (JENA) NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1