BEUDAMED
    FDA Adverse Event Other Summary report: N

    POSTERIOR CHAMBER LENS

    MDR report key: 315044 · Received February 2, 2001

    Report

    Report Number
    1119421-2001-00097
    Event Type
    Other
    Date Received
    February 2, 2001
    Report Date
    January 5, 2001
    Manufacturer
    ALCON LABORATORIES, INC. / HUNTINGTON
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL), CONSUMER IS SEEING CORNER FLASHING AND FLICKERING THAT STARTS AT THE TOP AND TRICKLES DOWN LIKE A TEAR DROP. CONSUMER IS ALSO SEEING OBJECTS WITH A DOUBLE EFFECT, AND SEEING HALF CIRCLES WHEN LOOKING AT CAR LIGHTS. CONSUMER REPORTEDLY HAS NO DEPTH PERCEPTION. THE ASSOCIATION BETWEEN THIS EVENT AND THE IOL IS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4147 POSTERIOR CHAMBER LENS INTRAOCULAR LENS HQL ALCON LABORATORIES, INC. / HUNTINGTON LX10BD 478599

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other