BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1246427 · Received November 20, 2008

    Report

    Report Number
    1119421-2008-00935
    Event Type
    Other
    Date Received
    November 20, 2008
    Date of Event
    September 8, 2008
    Report Date
    October 29, 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
    CA, 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 HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFO WAS REQUESTED BY PHONE ON 10/30/2008 AND 11/06/2008 AND BY FAX AND MAIL ON 10/30/2008, 11/06/2008 AND BY EMAIL ON 11/13/2008. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 11/13/2008.

    Description of Event or Problem · 1

    A CONSUMER REPORTS EXPERIENCING HALOS AND A DECREASE IN VISUAL ACUITY FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE CONSUMER ALSO REPORTS THAT THE PHYSICIAN IS TREATING HER FOR DRY EYES. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD./HUNTINGTON NI 10777356

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other