BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1365019 · Received April 17, 2009

    Report

    Report Number
    1119421-2009-00370
    Event Type
    Other
    Date Received
    April 17, 2009
    Date of Event
    January 1, 2008
    Report Date
    March 19, 2009
    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
    OR, 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 BY FAX AND MAIL ON 03/20/2009 AND BY PHONE ON 03/20/2009 AND 04/02/2009. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. THIS REPORT WAS MAILED TO FDA ON: 04/17/2009.

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT HE HAS A PATIENT WHO IS EXPERIENCING POOR VISION, PHOTOPHOBIA, BLURRED VISION, AND CLOUD LIKE FLOATERS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD. / HUNTINGTON SN60D3 10700213

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other