BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1221635 · Received November 5, 2008

    Report

    Report Number
    1119421-2008-00881
    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
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 ON 10/08/2008 AND 10/21/2008 BY PHONE, FAX, OR MAIL. A COMPLETED QUESTIONAIRE HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    A SURGICAL TECHNICIAN REPORTS A PATIENT EXPERIENCING DISTORTED AND DOUBLE VISION FOLLOWING INTRAOCULAR (IOL) IMPLANT SURGERY. THE PATIENT WAS REFERRED TO A RETINAL SPECIALIST WHO REPORTS RETIAL PIGMENT EPITHELIAL CHANGES THAT HE FELT WERE CONSISTENT WITH AGE RELATED MACULAR DEGENERATION. HE ALSO RECOMMENDED A LENS EXCHANGE. HOWEVER, THE LENS WAS NOT EXCHANGED. ADDITIONAL INFORMATION HAS BEEN REQUESTED . THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. 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 10738470

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other