BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASY LOAD INSERTER

    MDR report key: 1001832 · Received February 25, 2008

    Report

    Report Number
    1920664-2008-00261
    Event Type
    Injury
    Date Received
    February 25, 2008
    Date of Event
    January 24, 2005
    Report Date
    January 25, 2008
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    KYB
    PMA / PMN Number
    P910061
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SEE MDR 1920664-2008-00247 FOR THE INTROCULAR LENS USED WITH THIS DELIVERY DEVICE.

    Description of Event or Problem · 1

    THE HAPTIC BENT IN THE DELIVERY DEVICE DURING THE INSERTION OF THE LENS INTO THE PT'S EYE. 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 KYB BAUSCH & LOMB, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention