BEUDAMED
    FDA Adverse Event Summary report: N

    BOSTON KERATOPROSTHESIS

    MDR report key: 2956534 · Received February 1, 2013

    Report

    Report Number
    1222945-2013-00001
    Date Received
    February 1, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 12, 2013
    Manufacturer
    MASSACHUSETTS EYE AND EAR INFIRMARY
    Product Code
    HQM
    PMA / PMN Number
    K915062
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT APPEARS THAT THE DURING SHIPMENT OR SUBSEQUENT HANDLING THE BACK PLATE SLIPPED ONTO THE STEM OF THE FRONT PLATE. THE CLOCKING RING WAS NOT ENGAGE, SO THE DEVICE WAS NOT TRULY ASSEMBLED. THE CHIP IN THE BACK PLATE AS CONFIRMED ON EXAMINATION. A REVIEW OF THE PACKAGING AND ASSEMBLY OR BOSTON KERATOPROSTHESIS WAS REVIEWED AND THE INSPECTIONS FOR THE COMPONENTS SHOWED NO INDICATION OF DAMAGE OR CHIPS. THE PACKAGING PROCESS REQUIRES TWO SEPARATE MICROSCOPIC EXAMINATIONS OF EACH COMPONENT OR DEBRIS OR DAMAGE.

    Description of Event or Problem · 1

    UPON OPENING PACKAGE AND INSPECTING THE BOSTON KERATOPROSTHESIS, FRONT PLATE AND BACK PLATE WERE ASSEMBLED- WHEN INSPECTING FRONT PLATE, SMALL CHIP NOTED IN OPTIC WITH CHIP PIECE MISSING. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43856 BOSTON KERATOPROSTHESIS KERATOPROSTHESIS HQM MASSACHUSETTS EYE AND EAR INFIRMARY TYPE I

    Patients

    Seq Age Sex Outcome Treatment
    1