BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IOLMASTER

    MDR report key: 2631049 · Received June 21, 2012

    Report

    Report Number
    9615030-2012-00001
    Event Type
    Injury
    Date Received
    June 21, 2012
    Report Date
    June 21, 2012
    Manufacturer
    CARL ZEISS MEDITEC AG (JENA SITE)
    Product Code
    HJO
    PMA / PMN Number
    K101182
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A MFR SVC REP PERFORMED AN ON-SITE EVAL OF THE INSTRUMENT. CALIBRATION AND OPERATION WERE VERIFIED. THE SVC REPORT INDICATES THAT THE CUSTOMER DOES NOT HAVE A TEST EYE TO VERIFY INSTRUMENT CALIBRATION. ACCORDING TO THE IOLMASTER USER MANUAL: "THE CALIBRATION MUST BE CHECKED EVERY DAY BEFORE STARTING MEASUREMENTS ON A PT." ADD'L INFO HAS BEEN REQUESTED FROM THE SITE IN ORDER TO COMPLETE THE EVAL.

    Description of Event or Problem · 1

    USER REP REPORTED THAT A PT (PT #1) REQUIRED SECONDARY SURGERY TO REMOVE A PREVIOUSLY IMPLANTED INTRAOCULAR LENS (UNK DIOPTERS) AND TO IMPLANT A DIFFERENT POWER OF INTRAOCULAR LENS (UNK DIOPTERS).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention