BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSTAAR INJECTOR

    MDR report key: 1945227 · Received December 21, 2010

    Report

    Report Number
    2023826-2010-01285
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    December 2, 2010
    Report Date
    December 3, 2010
    Manufacturer
    STAAR JAPAN INC.
    Product Code
    MSS
    PMA / PMN Number
    K090161
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVALUATION METHOD: LENS WORK ORDER SEARCH. RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER. CONCLUSIONS: NO CONCLUSION CAN BE DRAWN. BASED ON THE COMPLAINT HISTORY AND WORK ORDER SEARCH, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE SURGEON WAS INSERTING A 21.5 DIOPTER CQ2015A COLLAMER ASPHERIC THREE PIECE LENS AND NOTED, LOOKING AT THE LENS UNDER THE MICROSCOPE, THE LENS LOOKED LIKE IT HAD TWISTED AND THE BACK HAPTIC WAS BEING PUSHED FORWARD OVER THE LENS BY THE PLUNGER INSIDE THE CARTRIDGE. THE SURGEON DECIDED NOT TO CONTINUE EJECTING THE LENS, THERE WAS NO PT CONTACT OR INJURY. ANOTHER SAME MODEL LENS WAS LOADED INTO A FRESH INJECTOR SYSTEM AND THE LENS WAS IMPLANTED WITH NO PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROSTAAR INJECTOR INTRAOCULAR LENS FOLDERS AND INJECTORS MSS STAAR JAPAN INC. EPIPHANY UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 LENS MODEL CQ2015A, (B)(4)