BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1120785 · Received August 15, 2008

    Report

    Report Number
    1119421-2008-00600
    Event Type
    Other
    Date Received
    August 15, 2008
    Date of Event
    January 1, 2008
    Report Date
    July 16, 2008
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE DEVICE REMAINS IMPLANTED. RESULTS FROM THE PRODUCT HISTORY REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADD'L INFO WAS REQUESTED ON 07/18/2008 AND 07/24/2008 BY PHONE, FAX AND MAIL. ADDITIONAL INFO WAS RECEIVED ON 07/16/2008. A COMPLETED QUESTIONNAIRE HAS BEEN RECEIVED.

    Description of Event or Problem · 1

    A SURGEON REPORTS FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANTATION, THE PT HAD BLURRY INTERMEDIATE VISION. SURGEON HAS PRESCRIBED GLASSES AS NEEDED FOR DRIVING AND WORK. OTHERWISE, THE SURGEON HAS ADVISED THE PT TO TRY TO REHABILITATE HIS VISION WITHOUT GLASSES. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THESE EVENTS. THIS REPORT IS FOR THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD./HUNTINGTON SN6AD3 10750003

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other