BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 516449 · Received March 10, 2004

    Report

    Report Number
    MW1031477
    Event Type
    Injury
    Date Received
    March 10, 2004
    Date of Event
    February 12, 2004
    Report Date
    February 25, 2004
    Manufacturer
    BAUSCH-LOMB STORZ INSTRUMENT CO.
    Product Code
    HRK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING CATARACT SURGERY, PHACO PROCESS, OSHER LENS MANIPULATOR TIP BROKE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * MANIPULATOR - OSHER NUCLEUS 0.5 MM HRK BAUSCH-LOMB STORZ INSTRUMENT CO. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR