BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1342440 · Received March 6, 2009

    Report

    Report Number
    1119421-2009-00171
    Event Type
    Other
    Date Received
    March 6, 2009
    Report Date
    February 4, 2009
    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
    MS, 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 INFORMATION WAS REQUESTED BY FAX AND MAIL ON 02/09/2009 AND BY PHONE ON 02/05/2009, 02/17/2009 AND 02/23/2009. ADDITIONAL INFORMATION WAS RECEIVED BY PHONE ON 02/17/2009. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. THIS REPORT WAS MAILED TO FDA ON: 03/06/2009.

    Description of Event or Problem · 1

    A CONSUMER EXPERIENCED POOR INTERMEDIATE VISUAL ACUITY INDOORS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. SHE WAS PRESCRIBED EYEGLASSES BUT STATES THEY DO NOT HELP. THE SURGEON REFERRED THE CONSUMER TO AN OPTOMETRIST BUT HAS NOT RECEIVED A FOLLOW-UP REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS IS FOR THE FELLOW EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD. / HUNTINGTON SN6AD3 10766610

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other