BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPHTHALMIC OPERATING MICROSCOPE

    MDR report key: 33725 · Received June 25, 1996

    Report

    Report Number
    MW1009378
    Event Type
    Injury
    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
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT'S VISION IN THE RIGHT EYE WAS NOTED TO BE EXTREMELY BLURRY AT FIRST POST-OPERATIVE EXAM ON 5/2/95. BY 5/30/95, THERE APPEARED TO BE PIGMENT CHANGES IN THE MACULA WITH THE APPEARANCE OF POSSIBLE RETINAL PHOTOTOXICITY RELATED TO LIGHT EXPOSURE DURING THE CATARACT EXTRACTION. BY 6/27/95, VISUAL ACUITY HAD DROPPED IN THE AFFECTED EYE TO COUNTING FINGERS ONLY. WITH BEST CORRECTION, VISUAL ACUITY IMPROVED TO 20/400-AND HAS REMAINED AT THIS LEVEL. PT WAS REFERRED TO RETINA SPECIALIST ON 7/2/95 WHO PERFORMED FLUOROSCEIN ANGIOGRAPHY WHERE EDEMA WAS NOTED IN THE CENTER OF THE RIGHT MACULA. PT WAS BEGUN ON PRED FORTE AND ACULAR EYE DROPS IN AN EFFORT TO RESOLVE THE EDEMA.

    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 78 YR Disability LIGHT SOURCE FOR MICROSCOPE VIKO AV/PHOTO LAMP BUL