BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1442735 · Received August 7, 2009

    Report

    Report Number
    1119421-2009-00763
    Event Type
    Other
    Date Received
    August 7, 2009
    Date of Event
    July 1, 2009
    Report Date
    July 10, 2009
    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
    CA, 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 ON 07/10/2009, 07/14/2009, 07/15/2009, AND 08/05/2009 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. THIS REPORT WAS MAILED TO FDA ON: 08/07/2009.

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT HE IS SEEING A LINE OF LIGHT AT 20 DEGREES FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE SURGEON REPORTED THAT HE DOES NOT BELIEVE THERE IS ANYTHING WRONG WITH THE IOL, BUT FEELS THE SQUARE EDGE MAY BE A CONTRIBUTING FACTOR TO THE EVENT. HE CONTINUES TO MONITOR THE PT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH. LTD. / HUNTINGTON SN60WF 10871209

    Patients

    Seq Age Sex Outcome Treatment
    1 Other