BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASY LOAD INSERTER

    MDR report key: 1021077 · Received March 27, 2008

    Report

    Report Number
    1920664-2008-00414
    Event Type
    Injury
    Date Received
    March 27, 2008
    Date of Event
    February 28, 2008
    Report Date
    February 28, 2008
    Manufacturer
    BAUSCH & LOMB
    Product Code
    MSS
    PMA / PMN Number
    K970727
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SEE MDR1920664-2008-00413 FOR THE INTRAOCULAR LENS USED WITH THIS DELIVERY DEVICE.

    Description of Event or Problem · 1

    THE HAPTIC BROKE DURING THE INSERTION OF THE LENS INTO THE PT'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 LOAD INSERTER INTRAOCULAR LENS DELIVERY DEVICE MSS BAUSCH & LOMB H734402

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention