BEUDAMED
    FDA Adverse Event Other Summary report: N

    POSTERIOR CHAMBER LENS

    MDR report key: 1141349 · Received August 28, 2008

    Report

    Report Number
    1119421-2008-00632
    Event Type
    Other
    Date Received
    August 28, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 28, 2008
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P840060
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE DEVICE REMAINS IMPLANTED. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFO WAS REQUESTED ON 07/30/2008.

    Description of Event or Problem · 1

    A CONSUMER REPORTED SEEING SHADOW IN THE FORM OF A LITTLE DARK GREY-BLACK DONUT TWO WEEKS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, HE ALSO STATED THAT "IT IS DISTURBING MY VISION AND MY LIFE". ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POSTERIOR CHAMBER LENS INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON LX10BD 10802977

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other