BEUDAMED
    FDA Adverse Event Other Summary report: N

    OPHTHALMIC OPERATING MICROSCOPE

    MDR report key: 33727 · Received June 25, 1996

    Report

    Report Number
    MW1009380
    Event Type
    Other
    Date Received
    June 25, 1996
    Date of Event
    May 1, 1995
    Report Date
    December 6, 1995
    Manufacturer
    CARL ZEISS, INC.
    Product Code
    HRM
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT'S RIGHT EYE EXHIBITED EVIDENCE OF MACULAR PHOTOTOXICITY POSSIBLY RELATED TO LIGHT FROM OPERATING ROOM MICROSCOPE FOLLOWING CATARACT EXTRACTION AND INTRAOCULAR LENS IMPLANTATION WHEN EXAMINED 2 WEEKS AFTER SURGERY. THIS CONTINUED TO IMPROVE WITHOUT INTERVENTION AND THE PT HAS AEQUIRED GOOD VISUAL ACUITY BY 9/5/95.

    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 70 YR Other LIGHT SOURCE FOR MICROSCOPE