BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1182403 · Received September 12, 2008

    Report

    Report Number
    1119421-2008-00708
    Event Type
    Other
    Date Received
    September 12, 2008
    Date of Event
    May 1, 2008
    Report Date
    August 15, 2008
    Manufacturer
    ALCON RESEARCH, LTD/HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    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 RECORDS REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED ON 08/21/2008 AND 09/03/2008 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. THIS REPORT WAS MAILED TO FDA ON: 09/12/2008.

    Description of Event or Problem · 1

    A CONSUMER REPORTS EXPERIENCING A LOSS OF PERIPHERAL FIELD VISION FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY. HE FURTHER REPORTS, HE HAS A DARK AREA ON THE PERIPHERY OF BOTH EYES, LIKE TUNNEL VISION THAT IS WORSE WHEN HE SQUINTS. HE WAS PRESCRIBED GLASSES AND THEY DO HELP. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THESE EVENTS. THIS REPORT IS FOR THE FELLOW EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD/HUNTINGTON SN60WF 10777992

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other