BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASY LOAS INSERTER

    MDR report key: 949507 · Received November 16, 2007

    Report

    Report Number
    1920664-2007-01444
    Event Type
    Injury
    Date Received
    November 16, 2007
    Date of Event
    October 16, 2007
    Report Date
    October 18, 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 1920664-2007-01443 FOR THE INTRAOCULAR LENS USED WITH THIS DELIVERY DEVICE.

    Description of Event or Problem · 1

    THE LEADING HAPTIC BENT 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 LOAS INSERTER INTRAOCULAR LENS DELIVERY DEVICE KYB BAUSCH & LOMB UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention