BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPD - SCAN III

    MDR report key: 7929989 · Received October 2, 2018

    Report

    Report Number
    MW5080311
    Event Type
    Injury
    Date Received
    October 2, 2018
    Date of Event
    June 8, 2018
    Report Date
    August 28, 2018
    Manufacturer
    MARCO OPHTHALMIC INC.
    Product Code
    HOX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I REQUESTED LENS CRAFTERS NOT TAKE ANY PICTURES OF MY EYE. THEY PUT ME IN FRONT OF A MACHINE AND HAD ME LOOK INTO IT, I ASKED WHAT THEY WERE DOING, SHE SAID MEASURING EYES AND A VERY INTENSE FLASH WENT OFF. IT REALLY AFFECTED ME IMMEDIATELY. I WAS VERY ALARMED AND UNCOMFORTABLE. IMMEDIATELY AFTER FLASH I EXPERIENCED EYE HEADACHE BETWEEN EYES, GLARES, EXTREME SENSITIVITY TO LIGHT, AND ANXIETY. I COMPLAINED TO ASSISTANT AND DOCTOR ON SITE, CASHIERS AND EYE ASSISTANTS WHEN TRYING TO PURCHASE GLASSES. NO ONE TOOK THE TIME OUT TO SIT ME DOWN AND ASK ME IF I NEEDED ASSISTANCE OR WATER. THEY ALL IGNORED ME. THEY NEVER INFORMED ME OR PREPARED ME FOR THE EXTREME FLASH A BLUE LED LIGHT. I BELIEVE THEY PURPOSELY DID THIS BECAUSE I REFUSED CAMERAS BEFORE EXAM STARTED. AFFECTED QUALITY OF LIFE, EYES ARE AFFECTED WITH GLASSES, EYE SENSITIVITY, AND EYE HEADACHES AFFECTS DRIVING AND CONCENTRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768169 OPD - SCAN III RETRACTOMETER, OPHTHALMIC HOX MARCO OPHTHALMIC INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other