BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1221636 · Received November 5, 2008

    Report

    Report Number
    1119421-2008-00871
    Event Type
    Other
    Date Received
    November 5, 2008
    Date of Event
    January 1, 2008
    Report Date
    October 6, 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
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE DEVICE REMAINS IMPLANTED. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THIS REPORT WAS MAILED TO FDA ON: 11/05/2008.

    Description of Event or Problem · 1

    A SURGEON REPORTED HAVING A NUMBER OF PATIENT EXPERIENCING AN INFLAMMATORY REACTION A FEW WEEKS TO A FEW MONTHS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. HE ALSO NOTICED CLOUDING ON THE ANTERIOR SURFACE OF THE LENS. HE STATED THAT "THE PATIENTS STILL SEE FINE."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other