BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1421707 · Received July 24, 2009

    Report

    Report Number
    1119421-2009-00738
    Event Type
    Other
    Date Received
    July 24, 2009
    Date of Event
    January 1, 2009
    Report Date
    June 29, 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
    KS, US
    Reporter Occupation
    OTHER

    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 06/30/2009, 07/06/2009, 07/10/2009 AND 07/22/2009 BY MAIL, FAX AND PHONE. ADDITIONAL INFO WAS RECEIVED 07/22/2009 BY PHONE. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. THIS REPORT WAS MAILED TO FDA ON: 07/24/2009.

    Description of Event or Problem · 1

    A SURGEON REPORTS THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A PT IS SEEING STARBURSTS. IN THE SURGEON'S OPINION, THE EVENT IS NOT LENS RELATED AND IS DUE TO WRINKLES IN THE POSTERIOR CAPSULE THAT SHOULD STRAIGHTEN OUT WITH TIME. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH LTD./HUNTINGTON SN60WF 10833819

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other BETIMOL