BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1521491 · Received November 4, 2009

    Report

    Report Number
    1119421-2009-01039
    Event Type
    Injury
    Date Received
    November 4, 2009
    Date of Event
    January 1, 2009
    Report Date
    October 5, 2009
    Manufacturer
    ALCON MANUFACTURING, LTD. / HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR ANALYSIS AND WAS VERIFIED TO HAVE SIGNS OF HANDLING. THE OPTIC WAS SCRATCHED. WHILE WE WERE UNABLE TO DETERMINE THE ORIGIN OF THE DAMAGE, OUR OBSERVATIONS REASONABLY SUGGEST THE DAMAGE IS NOT MANUFACTURING RELATED. PRODUCT HISTORY RECORDS WERE REVIEWED AND ALL DOCUMENTS INDICATE THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADD'L INFO WAS REQUESTED ON 10/05/2009, 10/26/2009, AND 11/04/2009 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. THIS REPORT WAS MAILED TO FDA ON: 11/04/2009.

    Description of Event or Problem · 1

    A NURSE REPORTED AN INTRAOCULAR LENS (IOL) WAS EXCHANGED, DUE TO THE PT BEING INTOLERANT OF BLURRY NEAR VISION. ADD'L INFO HAD BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON MANUFACTURING, LTD. / HUNTINGTON SN6AD3 10736854

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention