BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASY LOAD INSERTER

    MDR report key: 2893390 · Received June 1, 2007

    Report

    Report Number
    1920664-2007-00654
    Event Type
    Injury
    Date Received
    June 1, 2007
    Date of Event
    May 4, 2007
    Report Date
    May 4, 2007
    Manufacturer
    BAUSCH & LOMB
    Product Code
    MSS
    PMA / PMN Number
    K970727
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SEE MDR 1920664-2007-00653 FOR INTRAOCULAR LENS USED WITH THIS DELIVERY DEVICE.

    Description of Event or Problem · 1

    AFTER THE LENS WAS INSERTED INTO THE PT'S EYE USING THE DELIVERY DEVICE, THE LENS WAS FOUND DAMAGED. THE LENS WAS REMOVED AND REPLACED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention