BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFLEX SILICONE SQUARE EDGE FOLDABLE LENS

    MDR report key: 1040079 · Received May 7, 2008

    Report

    Report Number
    1920664-2008-00529
    Event Type
    Injury
    Date Received
    May 7, 2008
    Date of Event
    April 9, 2008
    Report Date
    April 9, 2008
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQL
    PMA / PMN Number
    P910061
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SEE MDR 1920664-2008-00530 FOR DELIVERY DEVICE USED WITH THIS THE INTRAOCULAR LENS.

    Description of Event or Problem · 1

    THE LENS DID NOT INSERT CORRECTLY INTO THE PT'S EYE. THE INCISION WAS ENLARGED TO REMOVE AND REPLACE THE LENS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention