BEUDAMED
    FDA Adverse Event Other Summary report: N

    IOL MASTER

    MDR report key: 2214084 · Received July 21, 2011

    Report

    Report Number
    9615030-2011-00005
    Event Type
    Other
    Date Received
    July 21, 2011
    Report Date
    July 21, 2011
    Manufacturer
    CARL ZEISS MEDITEC
    Product Code
    HJO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERVICE REPORT NOTES THAT THE INSTRUMENT WAS FUNCTIONING WITHIN ZEISS'S SPECIFICATIONS AND DID NOT REQUIRE ANY CALIBRATION. THE INSTRUMENT DEVICE LOG INDICATES THAT THE DAILY REQUIRED CALIBRATION HAD NOT BEEN PERFORMED ON THE IOL MASTER FROM (B)(6) 2010 TO (B)(6) 2011. THEREFORE, IT APPEARS THAT THE USER HAS FAILED TO FOLLOW INSTRUCTIONS AS ACCORDING TO THE IOL MASTER USER MANUAL: "THE CALIBRATION MUST BE CHECKED EVERY DAY BEFORE STARTING MEASUREMENTS ON A PATIENT." (B)(6) HAS CONTACTED THE SITE ON SEVERAL OCCASIONS TO REQUEST THE PREOPERATIVE AND POSTOPERATIVE INFORMATION FOR USE IN DETERMINING THE ROOT CAUSE. AS OF TODAY, THE SITE HAS NOT PROVIDED THIS INFORMATION.

    Description of Event or Problem · 1

    A PATIENT UNDERWENT SURGERY TO IMPLANT A MULTI-FOCAL INTRAOCULAR LENS AFTER BEING EXAMINED WITH THE IOL MASTER. THE DOCTOR REPORTED THAT THE POSTOPERATIVE REFRACTION WAS NOT DIFFERENT AFTER THE SURGERY. THE PATIENT REQUIRED A SECOND SURGERY TO CORRECT THE REFRACTIVE ERROR AFTER THE INITIAL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IOL MASTER SLITLAMP, BIOMICROSCOPE HJO CARL ZEISS MEDITEC IOL WITH SW 5.4.3

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other