BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1002942 · Received February 7, 2008

    Report

    Report Number
    1119421-2008-00048
    Event Type
    Other
    Date Received
    February 7, 2008
    Date of Event
    January 1, 2007
    Report Date
    January 8, 2008
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION; THE DEVICE REMAINS IMPLANTED. PRODUCT RECORD AND BATCH 032125 RECORDS WERE REVIEWED AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAS BEEN ONE SIMILAR COMPLAINT REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED 01/11/2008 AND 01/14/2008 BY PHONE, FAX AND MAIL. PATIENT RECORDS WERE RECEIVED 01/11/2008. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RETURNED. THIS REPORT WAS MAILED TO FDA ON: 02/07/2008.

    Description of Event or Problem · 1

    A SURGEON REPORTS THAT TWO YEARS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A PATIENT PRESENTS WITH BILATERAL GLISTENINGS AND DECREASED VISUAL ACUITY. ADDITIONAL INFORMATION, INCLUDING PATIENT STATUS, HAS BEEN REQUESTED. THERE ARE TWO MANUFACTURER'S DEVICE REPORTS ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN60AT 784494

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other