BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOMOGRAPHY, OPTICAL COHERENCE

    MDR report key: 11685049 · Received April 16, 2021

    Report

    Report Number
    MW5100839
    Event Type
    Injury
    Date Received
    April 16, 2021
    Date of Event
    January 10, 2019
    Report Date
    April 19, 2021
    Manufacturer
    CARL ZEISS MEDITEC AG (JENA)
    Product Code
    OBO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    A REPORTER CALLED TO REPORT THAT HE EXPERIENCED AN ADVERSE EVENT AS A RESULT OF A USER ERROR WHEN HE HAD EYE EXAM PERFORMED USING AN OPTICAL COHERENCE TOMOGRAPHY DEVICE. HE STATED THE OPERATOR USED DIFFERENT DEVICES FOR EYE EXAM THAT DAY AND ONE THE DEVICES USED WAS AN OPTICAL COHERENCE TOMOGRAPHY. THE OPERATOR DID NOT USE THE DEVICE FOLLOWING INSTRUCTION FOR USE BY THE MANUFACTURER. THE MANUFACTURER WARNS IF THE DEVICE IS USED LONGER THAN NECESSARY, IT CAUSES EYE DAMAGE. HOWEVER, THE OPERATOR, WHETHER IT WAS LACK OF TRAINING OR NOT READING THE INSTRUCTIONS THOROUGHLY, HE DID NOT USE THE DEVICE PER THE MANUFACTURER'S INSTRUCTIONS. THE REPORTER SAID AS A RESULT OF THE DEVICE MISUSE, HE EXPERIENCED A CONDITION CALLED POSTERIOR VITREOUS DETACHMENT. HE SAID JUST IN A FEW HOURS, HE EXPERIENCED SYMPTOMS OF POSTERIOR VITREOUS DETACHMENT, WHICH IS PHOTOTOXICITY. HE EVENTUALLY START SEEING FLOATERS, THEY APPEAR LIKE SPIDERWEBS, AND THE FLOATERS GOTTEN BIGGER AND NOTICEABLE. HE SAID THE FLOATERS START BOUNCING WHEN HE MOVES HIS HEAD. HE ALSO EXPERIENCED MOBILE BLURRY SHADOWS THAT OBSCURE HIS VISION WHICH CAUSED A DISTURBANCE OF HIS FIELD OF VISION, ON HIS RIGHT EYE HE SAID HE ALSO SAW SOMETHING LIKE A ROUND SCAR, THAT IS WHEN HE FOUND OUT HE WAS EXPERIENCING A POSTERIOR VITREOUS DETACHMENT AND ALSO CONFIRMED BY HIS OPHTHALMOLOGIST. HE DOES NOT THINK THE DEVICE FAILED INSTEAD THE DEVICE WAS NOT USED PROPERLY BY THE OPERATOR.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM REPORTER ON 4/19/2021 FOR REPORT MW5100893. REPORTER WANTED TO UPDATE HIS REPORT WITH CORRECT DATES. REPORTER STATED HE SAW THE FIRST DOCTOR, DR. (B)(6), ON THURSDAY (B)(6) 2019. PATIENT STATED HE EXPERIENCED THE VITREOUS DETACHMENT ON MONDAY, (B)(6) 2019 AND SAW DR. (B)(6) ON TUESDAY (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580075 TOMOGRAPHY, OPTICAL COHERENCE TOMOGRAPHY, OPTICAL COHERENCE OBO CARL ZEISS MEDITEC AG (JENA)

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR