BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF TORIC

    MDR report key: 1182406 · Received September 12, 2008

    Report

    Report Number
    1119421-2008-00693
    Event Type
    Other
    Date Received
    September 12, 2008
    Date of Event
    July 1, 2008
    Report Date
    August 13, 2008
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    MJP
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, 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 08/15/2008, 08/19/2008 AND 09/02/2008 BY MAIL, FAX AND PHONE. ADDITIONAL INFORMATION WAS RECEIVED 08/15/2008 BY PHONE. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    A CONSUMER REPORTS EXPERIENCING FLICKERING AROUND THE PERIMETER OF HIS VISION WHEN HE MOVES HIS HEAD FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY. HE REPORTS THAT HIS DISTANCE VISION IN BOTH EYES IS EXCELLENT AND THAT HE WEARS GLASSES FOR READING. ADDITIONAL INFORMATION HAS BEEN REQUESTED. 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 TORIC INTRAOCULAR LENS MJP ALCON RESEARCH, LTD./HUNTINGTON SN60T5 10732845

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other