BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASY LOAD INSERTER

    MDR report key: 1000951 · Received February 20, 2008

    Report

    Report Number
    1920664-2008-00230
    Event Type
    Injury
    Date Received
    February 20, 2008
    Date of Event
    January 22, 2008
    Report Date
    January 22, 2008
    Manufacturer
    BAUSCH & LOMB
    Product Code
    KYB
    PMA / PMN Number
    K970727
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SEE MDR 1920664-2008-00229 FOR THE INTRAOCULAR LENS USED WITH THIS DELIVERY DEVICE.

    Description of Event or Problem · 1

    THE LENS STUCK IN THE DELIVERY DEVICE DURING THE INSERTION IN THE PT'S EYE. ANOTHER LENS WAS USED TO COMPLETE THE PROCEDURE.

    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