BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IOLMASTER 500

    MDR report key: 3987586 · Received July 25, 2014

    Report

    Report Number
    9615030-2014-00003
    Event Type
    Injury
    Date Received
    July 25, 2014
    Date of Event
    May 3, 2014
    Report Date
    July 25, 2014
    Manufacturer
    CARL ZEISS MEDITEC AG
    Product Code
    HJO
    PMA / PMN Number
    K122418
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS PREVIOUSLY SUBMITTED IN ERROR ON JULY 17, 2014 AS MEDWATCH MFR REPORT #: 9615010-2014-00012. NARRATIVE: A FIELD SERVICE ENGINEER (FSE) PERFORMED AN ON-SITE EXAMINATION OF THE IOLMASTER 500. ALL PARAMETERS THAT INFLUENCE MEASUREMENT WERE WITHIN SPEC. TWO PARAMETERS WHICH DID NOT INFLUENCE THESE MEASUREMENTS WERE OUT OF SPEC AND ADJUSTED TO WITHIN SPEC. THE MFR REVIEWED THE OIL CALCULATION REPORT AND FOUND THE CALCULATIONS PERFORMED BY THE IOLMASTER 500 WERE CORRECT. WHEN THE IOLMASTER 500 IS USED BY A NUMBER OF DIFFERENT SURGEONS IT IS RECOMMENDED TO CREATE SURGEON RECORDS IN THE LENS MANAGER. THE USE OF THE LENS MANAGER IS DESCRIBED IN THE SOFTWARE USER MANUAL ON PAGE 21 NAD 22. THE SITE REPORTED THAT THEY HAVE IMPLEMENTED A CROSS-CHECKING PROTOCOL IN THEIR WORKFLOW TO SAFEGUARD AGAINST RECURRENCE OF THE REPORTED USER ERROR PROBLEM. (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A TECHNICIAN HAD SELECTED THE WRONG SURGEON'S NAME IN THE IOL CALCULATION SCREEN IN THE IOLMASTER 500. THE OPERATING SURGEON DID NOT NOTICE THAT THE PRINTOUT REFLECTED ANTHER SURGEON'S AC LENS IN HIS PREFERRED LENS COLUMN. AS A RESULT, THE OPERATING SURGEON CHOSE THE WRONG LENS POWER FOR HIS PT. THE PT'S PRE-OPERATIVE VISUAL ACUITY: 20/125 BEST CORRECTED. THE PT'S POST-OPERATIVE VISUAL ACUITY: 20/20 BEST CORRECTED AND 20/125 UNCORRECTED. THE PT'S STABLE POST-OPERATIVE REFRACTION: +3.75 DS. THE DIFFERENCE FROM TARGET REFRACTION: +3.75 DS. THE OPERATING SURGEON PERFORMED A FOLLOW UP SURGERY TO EXPLANT THE UNINTENDED IOL AND IMPLANT THE INTENDED IOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436695 IOLMASTER 500 BIOMICROSCOPE, SLIT-LAMP, AC-POWERED HJO CARL ZEISS MEDITEC AG IOLMASTER 500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other