BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1914401 · Received November 19, 2010

    Report

    Report Number
    1119421-2010-01287
    Event Type
    Other
    Date Received
    November 19, 2010
    Date of Event
    January 1, 2010
    Report Date
    October 21, 2010
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    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 10/22/2010 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 11/01/2010. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, HE HAD A BLUR ACROSS HIS FIELD OF VISION WHEN DRIVING AT NIGHT OR ANYTIME AGAINST A DARK BACKGROUND. THE CONSUMER REPORTED THE BLURRED LINE RUNS FROM THE UPPER LEFT NASAL AREA TO THE BOTTOM TEMPORAL AREA. THE WIDTH OF THE BLURRED AREA CHANGES DEPENDING ON THE INTENSITY OF THE LIGHT. IN A FOLLOW UP, THE SURGEON REPORTED, THE PT DID NOT VOICE THIS COMPLAINT TO HIM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN60WF 11005580

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other DISCOVISC