BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 991122 · Received February 1, 2008

    Report

    Report Number
    1119421-2008-00034
    Event Type
    Other
    Date Received
    February 1, 2008
    Date of Event
    January 1, 2007
    Report Date
    January 3, 2008
    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
    AZ, 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 INFORMATION WAS REQUESTED 01/04/2007, 01/07/2008 AND 01/11/2008 BY PHONE, MAIL AND FAX. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RETURNED. THIS REPORT WAS MAILED TO FDA ON: 02/01/2008.

    Description of Event or Problem · 1

    A CONSUMER REPORTS SEEING STARBURSTS AT NIGHT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. ADDITIONAL INFORMATION, INCLUDING PATIENT STATUS, HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN60WF 881343

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other