BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSTAAR INJECTOR CARTRIDGE

    MDR report key: 1083163 · Received July 24, 2008

    Report

    Report Number
    2023826-2008-01001
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Report Date
    July 3, 2008
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MSS
    PMA / PMN Number
    K980696
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINT WAS FOUND.

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON OBSERVED VERY FINE WHITE POWDER-LIKE SUBSTANCE IN AN SFC-45 FP CARTRIDGE, AFTER HAVING LOADED A -7.5 DIOPTER MICL 12.6 IMPLANTABLE COLLAMER LENS. THERE WAS NOT PATIENT CONTACT. SEE MFR REPORT # 2023826-2008-00999.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROSTAAR INJECTOR CARTRIDGE INTRAOCULAR LENS FOLDERS AND INJECTORS MSS STAAR SURGICAL COMPANY SFC-45 FP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 LENS MODEL MICL 12.6| INJECTOR MODEL AND LOT NUMBER UNK| FOAM TIP PLUNGER MODEL AND LOT NUMBER UNK