BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 884006 · Received July 20, 2007

    Report

    Report Number
    1119421-2007-00313
    Event Type
    Other
    Date Received
    July 20, 2007
    Date of Event
    September 27, 2006
    Report Date
    June 25, 2007
    Manufacturer
    ALCON LABORATORIES, INC.
    Product Code
    HQL
    PMA / PMN Number
    P930014
    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. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT. THIS REPORT WAS MAILED TO THE FDA ON: 07/20/2007. ADDITIONAL INFORMATION WAS REQUESTED 06/29/2007 AND 07/16/2007 BY FAX. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    A CONSUMER REPORTS VISUAL "FLICKERING/TWITCHING" AT READING DISTANCE AND IN CERTAIN LIGHTING CONDITIONS SINCE THE DAY FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. ADDITIONAL INFORMATION, INCLUDING PT STATUS, HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON LABORATORIES, INC. SA60AT 971920

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR Other