BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1148520 · Received August 20, 2008

    Report

    Report Number
    1119421-2008-00611
    Event Type
    Other
    Date Received
    August 20, 2008
    Date of Event
    April 8, 2008
    Report Date
    July 21, 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
    VA, 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 THIS LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED ON 07/22/2008, 07/23/2008, 07/24/2008 AND 08/05/2008 BY PHONE, FAX AND MAIL. A COMPLETED QUESTIONNAIRE HAS BEEN RECEIVED.

    Description of Event or Problem · 1

    A CONSUMER REPORTED HAVING BLURRY VISION, HALOS AND SHADOWS IN HER DISTANCE VISION FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. 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 SN6AD3 10758804

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other ZYMAR| PRED FORTE| XIBROM