BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1006822 · Received February 27, 2008

    Report

    Report Number
    1119421-2008-00102
    Event Type
    Malfunction
    Date Received
    February 27, 2008
    Date of Event
    January 28, 2008
    Report Date
    January 28, 2008
    Manufacturer
    ALCON RESEARCH LTD/HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    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. ADD'L INFO WAS REQUESTED 02/02/2008, 02/04/2008, 02/26/2008 AND 02/21/2008 BY PHONE, FAX AND MAIL. A COMPLETED QUESTIONAIRE WAS RECEIVED. THIS REPORT WAS MAILED TO FDA ON: 02/27/2008.

    Description of Event or Problem · 1

    A SURGEON REPORTS A MINIMAL AMOUNT OF GLISTENINGS IN A PT FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THERE ARE TWO MFR'S DEVICE REPORTS ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH LTD/HUNTINGTON SN60D3 143895

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR