BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 563774 · Received May 20, 2004

    Report

    Report Number
    1119421-2004-00162
    Event Type
    Other
    Date Received
    May 20, 2004
    Report Date
    April 20, 2004
    Manufacturer
    ALCON LABORATORIES, INC./HUNTINGTON
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A SURGEON REPORTS THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A PT IS EXPERIENCING NEGATIVE DYSPHOTOPSIA. THIS PT HAD IOLS IMPLANTED IN BOTH EYES. (INFO ON THE FELLOW EYE DOCUMENTED ON MDR REPORT #1119421-2004-00133 SUBMITTED 04/2004.) WHEN THE PT CLOSES THE LEFT EYE, THEY SEE THE DARK SHADOW IN THE RIGHT EYE. WHEN THEY CLOSED THE RIGHT EYE, THEY SEE THE DARK SHADOW IN THE LEFT EYE, BUT DOES NOT SEE THE DARK SHADOW MONOCULARLY. THE ASSOCIATION BETWEEN THIS EVENT AND THE IOL IS NOT KNOWN. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other