BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1155964 · Received September 5, 2008

    Report

    Report Number
    1119421-2008-00668
    Event Type
    Other
    Date Received
    September 5, 2008
    Date of Event
    January 1, 2008
    Report Date
    August 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
    MI, US
    Reporter Occupation
    UNKNOWN

    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 HAS BEEN ONE OTHER SIMILAR COMPLAINT REPORTED IN THIS LOT NUMBER BY THE SAME CONSUMER. ADDITIONAL INFO WAS REQUESTED 08/07/2008, 08/11/2008, 08/12/2008 AND 09/02/2008 BY MAIL, FAX AND PHONE. ADDITIONAL INFO WAS RECEIVED 08/07/2008, 08/11/2008, 08/20/2008 AND 08/21/2008 BY PHONE. PT RECORDS AND A COMPLETED QUESTIONNAIRE WERE RECEIVED 09/02/2008.

    Description of Event or Problem · 1

    A CONSUMER REPORTS THAT FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY, SHE HAS DIFFICULTY SEEING AT ALL DISTANCES AND AT NIGHT. THE CONSUMER HAS BEEN OFFERED VARIOUS OPTIONS BY HER SURGEON INCLUDING GLASSES, CONTACT LENSES AND LENS EXCHANGES. SHE CURRENTLY WEARS DIFFERENT GLASSES TO CORRECT VARIOUS DISTANCE VISIONS, BUT IS NOT PLEASED THAT THIS IS NECESSARY. IN FOLLOW UP, THE SURGEON REPORTS THE OUTCOME AND PROGNOSIS FOR THE PT AS "EXCELLENT". THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THESE EVENTS. 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 SN60D3 974924

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other