BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASY LOAD INSERTER

    MDR report key: 1013796 · Received March 14, 2008

    Report

    Report Number
    1920664-2008-00366
    Event Type
    Injury
    Date Received
    March 14, 2008
    Date of Event
    February 18, 2008
    Report Date
    February 19, 2008
    Manufacturer
    BAUSCH & LOMB
    Product Code
    MSS
    PMA / PMN Number
    P910061
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SEE MDR 1920664-2008-00365 FOR THE INTRAOCULAR LENS USED WITH THIS DELIVERY DEVICE.

    Description of Event or Problem · 1

    THE HAPTIC BROKE DURING THE INSERTION OF THE LENS IN THE PATIENT'S EYE. ANOTHER LENS WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASY LOAD INSERTER INTRAOCULAR LENS DELIVERY DEVICE MSS BAUSCH & LOMB H734901

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention