BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF

    MDR report key: 1170734 · Received September 15, 2008

    Report

    Report Number
    1119421-2008-00720
    Event Type
    Malfunction
    Date Received
    September 15, 2008
    Report Date
    June 30, 2008
    Manufacturer
    ALCON RESEARCH, LDT./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 ASSOCIATED WITH THIS REPORT HAS NOT BEEN RECEIVED FOR EVALUATION; THE DEVICE REMAINS IMPLANTED. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LENS SERIAL NUMBER, LOT NUMBER, OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ADDITIONAL INFORMATION WAS REQUESTED ON 09/12/2008 BY FAX AND MAIL. A COMPLETED QUESTIONAIRE HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    A SURGEON REPORTS SEEING SPOTS ON THE LENSES OF HIS PATIENTS FOLLOWING INTRAOCULAR LENS IMPLANT SURGERY. HE STATES THAT NONE OF HIS PATIENTS HAVE EXPERIENCED ANY DECLINE IN VISUAL ACUITY OR REPORTED ANY SPECIFIC COMPLAINTS ATTRIBUTABLE TO THE SPOTS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LDT./HUNTINGTON SA60AT NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI