BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IOLMASTER

    MDR report key: 2925005 · Received January 17, 2013

    Report

    Report Number
    9615030-2013-00001
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    November 26, 2012
    Report Date
    January 17, 2013
    Manufacturer
    CARL ZEISS MEDITEC AG (JENA SITE)
    Product Code
    HJO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE FIRST OF TWO REPORTABLE EVENTS OCCURRING ON THE SAME DAY AT THIS SITE. THE PT'S SECOND SURGERY WAS PERFORMED. A FIELD SERVICE ENGINEER PERFORMED AN ON-SITE EVAL OF THE IOLMASTER INSTRUMENT AND VERIFIED FULL FUNCTIONALITY OF THE INSTRUMENT. A REVIEW OF THE PT'S IOLMASTER DATA PRINTOUT BY MFR'S TECHNICAL REPS FOUND NO PROBLEMS. A CUSTOMER REP REPORTED THAT USER ERROR CONTRIBUTED TO THE SELECTION OF THE WRONG IOL; THE ORDER OF THE SELECTED IOLS PRESENTED IN THE IOLMASTER PRINTOUT (WHICH IS UNDER THE CONTROL OF THE OPERATOR) WAS DIFFERENT FROM THE ORDER TYPICALLY EXPECTED BY THE DOCTOR. NOTE: SITE IS THE SAME AS THE INITIAL RPTR.

    Description of Event or Problem · 1

    AFTER UNDERGOING SURGERY TO IMPLANT AN INTRAOCULAR LENS, THE PT EXPERIENCED A POOR POST-OPERATIVE OUTCOME OF +3.00 DIOPTERS. AS A RESULT, THE PT REQUIRED A SECOND SURGERY TO IMPROVE THE POST-OPERATIVE OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25625 IOLMASTER BIOMICROSCOPE, SLIT-LAMP, AC-POWERED HJO CARL ZEISS MEDITEC AG (JENA SITE) NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other