BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRI OCT TRITON (PLUS)

    MDR report key: 17555970 · Received August 16, 2023

    Report

    Report Number
    2242863-2023-00002
    Event Type
    Injury
    Date Received
    August 16, 2023
    Date of Event
    October 10, 2022
    Report Date
    August 16, 2023
    Manufacturer
    TOPCON CORPORATION
    Product Code
    OBO
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE PATIENT'S OCCUPATION IS A RESEARCHER IN GEOLOGY WHERE HE ANALYSES GEMSTONES AND EDUCATES HIS STUDENTS ON HOW TO ASSESS GEMSTONE COLOR AND CLARITY. ON (B)(6) 2023 THE PATIENT RETURNED FOR A ROUTINE FOLLOW-UP WHERE HE EXPLAINED THAT HE NOW HAS AN INABILITY TO ACCURATELY PERCEIVE YELLOW LIGHT WHEN LOOKING AT GEMSTONES UNDER ULTRAVIOLET LIGHT LONG WAVE 365 NM AND INSTEAD SEES THEM AS HAVING A PINK HUE. THE PATIENT ATTRIBUTES THIS CHANGE TO THE WHITE FLASH USED BY THE TRITON PLUS ON (B)(6) 2022. THIS IMPACT IN COLOR PERCEPTION WAS NOT DESCRIBED OUTSIDE THE CONTEXT OF UV-INDUCED VISUAL FLUORESCENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1686611 DRI OCT TRITON (PLUS) OPTICAL COHERENCE TOMOGRAPHER OBO TOPCON CORPORATION 470129900

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Disability