BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1063208 · Received June 19, 2008

    Report

    Report Number
    1119421-2008-00446
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    January 1, 2006
    Report Date
    May 20, 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
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR ANALYSIS AND WAS VERIFIED TO HAVE SIGNS OF HANDLING. THE OPTIC WAS SCRATCHED AND TORN/SPLIT/CRACKED INTO TWO PIECES (POSSIBLY CUT). LENS BRANCH COULD NOT BE CONDUCTED DUE TO OPTIC DAMAGE. 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. ADDITIONAL INFORMATION WAS REQUESTED 05/22/08 AND 06/04/2008 BY MAIL, FAX AND PHONE. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. THIS REPORT WAS MAILED TO FDA ON: 06/19/2008.

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXCHANGED. THE PATIENT HAD REPORTED ASTHENOPIA, BLURRED VISION AT ALL DISTANCES, AND AN OBLIQUE STREAK ACROSS HER VISION. SHE WAS PRESCRIBED EYE GLASSES, BUT THE SYMPTOMS DID NOT RESOLVE. THE PATIENT IS VERY HAPPY WITH THE OUTCOME FOLLOWING THE EXCHANGE. 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 955329

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention