BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 978056 · Received January 9, 2008

    Report

    Report Number
    1119421-2008-00001
    Event Type
    Other
    Date Received
    January 9, 2008
    Date of Event
    January 1, 2007
    Report Date
    December 10, 2007
    Manufacturer
    ALCON RESEARCH LTD / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS. ADD'L INFO WAS REQUESTED 12/12/2007, 12/13/2007 AND 01/03/2008 BY PHONE, MAIL AND FAX. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RETURNED.

    Description of Event or Problem · 1

    A SURGEON REPORTS THAT THREE YRS FOLLOWING INTRAOCULAR LENS IMPLANT SURGERY, A PT REPORTED THE LENS WAS CLOUDY. THE PT HAS BEEN EXPERIENCING CLOUDY VISION FOR THREE MONTHS. ADD'L INFO, INCLUDING PT STATUS, HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH LTD / HUNTINGTON SA60AT 639831

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other