BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 673465 · Received February 2, 2006

    Report

    Report Number
    1119421-2006-00020
    Event Type
    Other
    Date Received
    February 2, 2006
    Date of Event
    December 6, 2005
    Report Date
    January 3, 2006
    Manufacturer
    ALCON LABORATORIES INC./HUNTINGTON
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A SURGEON REPORTS A PATIENT HAS DESCRIBED SEEING DARK CIRCLES (AS IF HE IS SEEING THE EDGE OF THE LENS), FOLLOWING INTRAOCULAR LENS IMPLANT SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON LABORATORIES INC./HUNTINGTON SA60AT 920688

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other