BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPHTHALMIC OPERATING MICROSCOPE

    MDR report key: 33726 · Received June 25, 1996

    Report

    Report Number
    MW1009379
    Event Type
    Injury
    Date Received
    June 25, 1996
    Date of Event
    May 15, 1995
    Report Date
    December 6, 1995
    Manufacturer
    CARL ZEISS, INC.
    Product Code
    HRM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON 5/18/95, FOLLOWING CATARACT EXTRACTION ON THE RIGHT EYE WITH INTRAOCULAR LENS IMPLANTATION, PT CALLED TO REPORT AN OVAL SHAPED SCOTOMA IN THE OPERATED EYE. ON EXAM OF 5/18/95, PT WAS NOTED ON DILATED EXAM TO HAVE FLUID BENEATH THE MACULAR AREA CONSISTENT WITH POSSIBLE PHOTOXICITY TO THE RETINA. REFERRED TO RETINA SPECIALIST. VISUAL ACUITY ON 5/18/95 WAS DOWN TO 20/400 WITH BEST CORRECTION. VOLTARON WAS BEGUN 6/13/84 FOR ITS ANTIINFLAMMATORY PROPERTIES. VISUAL ACUITY IS UP WITH INCREASED BEST CORRECTION TO 20/40 BUT MACULAR PIGMENT CHANGES PERSIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPHTHALMIC OPERATING MICROSCOPE OPHTHALMIC OPERATING MICROSCOPE HRM CARL ZEISS, INC. 310187 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention LIGHT SOURCE FOR MICROSCOPE