BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 952491 · Received November 19, 2007

    Report

    Report Number
    1119421-2007-00494
    Event Type
    Other
    Date Received
    November 19, 2007
    Date of Event
    January 1, 2007
    Report Date
    October 20, 2007
    Manufacturer
    ALCON LABORATORIES, INC. / HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 ARE NO SIMILAR REPORTS IN THE LOT. THIS REPORT WAS MAILED TO THE FDA ON: 11/19/2007. ADDITIONAL INFO WAS REQUESTED ON 10/25/2007, 10/26/2007, 10/29/2007 AND 11/12/2007 BY EMAIL, PHONE, FAX AND MAIL. THE QUESTIONNAIRE HAS NOT BEEN RETURNED.

    Description of Event or Problem · 1

    A CONSUMER REPORTED HE SEES VERY WELL AT DISTANCE AND AT NEAR FOLLOWING (UNILATERAL) CATARACT EXTRACTION AND INTRAOCULAR LENS (IOL) IMPLANT SURGERY. HE REPORTED WHEN HE LOOKS THROUGH HIS TELESCOPE HE SEES FLARES WITH FUZZY EDGES INSTEAD OF SEEING THE STARS CLEARLY. HE ALSO REPORTED WHEN HE IS LOOKING AT BLACK LETTERING ON WHITE BACKGROUND. HE CAN SEE GRAY SHADOWS AT TIMES. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON LABORATORIES, INC. / HUNTINGTON SN6AD3 10732954

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other