BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASY LOA INSERTER

    MDR report key: 1407043 · Received June 23, 2009

    Report

    Report Number
    1920664-2009-00144
    Event Type
    Injury
    Date Received
    June 23, 2009
    Date of Event
    June 1, 2009
    Report Date
    June 1, 2009
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    MSS
    PMA / PMN Number
    K970727
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SEE MDR 1920664-2009-00143 FOR THE INTRAOCULAR LENS USED WITH THIS DELIVERY DEVICE.

    Description of Event or Problem · 1

    THE DOCTOR NOTICED THE HAPTIC WAS BENT AFTER IT WAS IMPLANTED IN THE PATIENT'S EYE. THE DOCTOR ENLARGED THE INCISION TO REMOVE AND REPLACE THE LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASY LOA INSERTER MSS BAUSCH & LOMB, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention