BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFLEX SILICONE SQUARE EDGE IOL

    MDR report key: 1259341 · Received December 9, 2008

    Report

    Report Number
    1920664-2008-01244
    Event Type
    Injury
    Date Received
    December 9, 2008
    Date of Event
    November 19, 2008
    Report Date
    November 19, 2008
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQL
    PMA / PMN Number
    P910061
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SEE MDR 1920644-208-01248 FOR THE DELIVERY DEVICE USED WITH THIS INTRAOCULAR LENS.

    Description of Event or Problem · 1

    THE LENS WAS FOUND TO BE DAMAGED AFTER THE LENS WAS IMPLANTED IN THE EYE. THE DOCTOR ENLARGED THE INCISION TO REMOVE AND REPLACE THE LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFLEX SILICONE SQUARE EDGE IOL INTRAOCULAR LENS HQL BAUSCH & LOMB

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention