BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFLEX SILICONE SQUARE EDGE FOLDABLE LENS

    MDR report key: 1063690 · Received June 19, 2008

    Report

    Report Number
    1920664-2008-00665
    Event Type
    Malfunction
    Date Received
    June 19, 2008
    Date of Event
    May 22, 2008
    Report Date
    May 22, 2008
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    HQL
    PMA / PMN Number
    P910061
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE HAPTIC WAS FOUND STRAIGHT UPON OPENING THE LENS CARRIER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1