BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MP-28 SOFPORT PLACEMENT SYSTEM

    MDR report key: 827779 · Received March 12, 2007

    Report

    Report Number
    1920664-2007-00273
    Event Type
    Injury
    Date Received
    March 12, 2007
    Date of Event
    February 11, 2007
    Report Date
    February 12, 2007
    Manufacturer
    BAUSCH & LOMB
    Product Code
    MSS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FORM WAS COMPLETED BY THE MANUFACTURER. SEE MDR 1920664-2007-000272 FOR INTRAOCULAR LENS USED WITH THE DELIVERY DEVICE.

    Description of Event or Problem · 1

    THE HAPTIC OF THE LENS WAS FOUND BROKEN AFTER INSERTION INTO THE PATIENT'S EYE USING THE DELIVERY DEVICE. THE LENS WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MP-28 SOFPORT PLACEMENT SYSTEM INTRAOCULAR LENS DELIVERY DEVICE MSS BAUSCH & LOMB * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention