BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 562661 · Received May 14, 2004

    Report

    Report Number
    1119421-2004-00150
    Event Type
    Other
    Date Received
    May 14, 2004
    Report Date
    April 14, 2004
    Manufacturer
    ALCON LABORATORIES, INC/HUNTINGTON
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A SURGEON REPORTS HE HAS SEVERAL PTS COMPLAINING ABOUT PERIPHERAL VISUAL CHANGES RANGING FROM SEEING AN ARC IN THE PERIPHERY TO SEEING A DARK SHADOW IN THE PERIPHERAL VISION. SPECIFIC PT AND EVENT INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON LABORATORIES, INC/HUNTINGTON SN60AT NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other