BEUDAMED
    FDA Adverse Event Summary report: N

    OPERATING MICROSCOPE

    MDR report key: 30873 · Received March 5, 1996

    Report

    Report Number
    MW1008533
    Date Received
    March 5, 1996
    Report Date
    February 10, 1996
    Manufacturer
    UNKNOWN
    Product Code
    HRM
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT HAD A POSTERIORLY-DISLOCATED IOL. WHEN RPTR FIRST EXAMINED THE EYE BEFORE THE SURGERY, THERE WAS SOME MILD PIGMENTARY MOTTLING IN THE MACULA AND THE VISION WAS SIGNIFICANTLY REDUCED. RPTR REPOSITIONED THE INTRAOCULAR LENS, ALTHOUGH IT DIDN'T CENTER PERFECTLY. IT HAS REMAINED IN GOOD ENOUGH POSITION, HOWEVER, TO ALLOW PROPERLY-CORRECTED VISION. THE VISION IN THE EYE DID NOT COME BACK FULLY TO NORMAL. THERE WERE SOME PROBLEMS WITH THE CORNEA, BUT RPTR ALSO BECAME MORE AWARE OF PIGMENTARY CHANGES IN THE MACULA. HE HAS BEEN SUSPICIOUS THAT THESE MIGHT HAVE BEEN DUE TO PHOTIC INJURY FROM THE OPERATING MICROSCOPE, POSSIBLY AT THE ORIGINAL CATARACT SURGERY. PT NOTES THE BIGGEST ABNORMALITY IN HIS VISION JUST ABOVE FIXATION ON THE AMSLER GRID. THE PIGMENTARY CHANGES IN THE RETINA HAVE BEEN JUST ABOVE THE FOVEA, WHICH ORDINARILY WOULD PRODUCE A PROBLEM ON THE AMSLER GRID JUST BELOW FIXATION. (*)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPERATING MICROSCOPE OPERATING MICROSCOPE HRM UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 *