BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASY LOAD INSERTER

    MDR report key: 1003545 · Received February 26, 2008

    Report

    Report Number
    1920664-2008-00257
    Event Type
    Injury
    Date Received
    February 26, 2008
    Date of Event
    December 29, 2007
    Report Date
    December 29, 2007
    Manufacturer
    BAUSCH & LOMB
    Product Code
    KYB
    PMA / PMN Number
    K970727
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SEE MDR 1920664-2008-00256 FOR THE INTRAOCULAR LENS USED WITH THIS DELIVERY DEVICE.

    Description of Event or Problem · 1

    THE LENS WAS FOUND DAMAGED AFTER THE INSERTION INTO THE PATIENT'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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention