BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1000886 · Received February 15, 2008

    Report

    Report Number
    1119421-2008-00075
    Event Type
    Other
    Date Received
    February 15, 2008
    Date of Event
    January 1, 2006
    Report Date
    January 17, 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 RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED 01/22/2008, 01/24/2008 AND 01/25/2008 BY PHONE, MAIL AND FAX. PATIENT RECORDS WERE RECEIVED 01/23/2008. THIS REPORT WAS MAILED TO FDA ON: 02/15/2008.

    Description of Event or Problem · 1

    A SURGEON REPORTS THAT FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A PATIENT REPORTS BLURRY INTERMEDIATE AND NEAR VISION. THE PATIENT WEARS READING GLASSES MOST OF THE TIME. THERE ARE TWO MANUFACTURERS 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 931462

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other PLAVIX| DIOVAN| COREG| LIPITOR| ZETIA - DAILY