BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRI OCT TRITON (PLUS)

    MDR report key: 17555977 · Received August 16, 2023

    Report

    Report Number
    9614661-2023-00001
    Event Type
    Injury
    Date Received
    August 16, 2023
    Date of Event
    October 10, 2022
    Report Date
    September 13, 2023
    Manufacturer
    TOPCON CORPORATION
    Product Code
    OBO
    PMA / PMN Number
    K173119
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION OF THE DEVICE FOUND NO MALFUNCTION THAT COULD BE ASSOCIATED WITH THE REPORTED SYMPTOM, AND THE DEVICE CONTINUES TO COMPLY WITH IEC-60825-1 AND ISO 15004-2. NO CAUSAL RELATIONSHIP BETWEEN THE PATIENT'S SYMPTOMS AND THE DEVICE WAS FOUND.

    Additional Manufacturer Narrative · 0

    THE PRODUCT CONFORMS TO IEC 60825-1 "SAFETY STANDARDS FOR LASER PRODUCTS" AND ISO 15004-2 "OPHTHALMIC INSTRUMENTS: PROTECTION FROM OPTICAL HAZARDS". THE PRODUCT POSSESSES SECONDARY PRODUCT CODE HKI (CAMERA, OPHTHALMIC, AC-POWERED). SIMILAR CASES HAVE NOT OCCURRED IN THE PAST. THE PATIENT'S EYESIGHT AND COLOR BLINDNESS TESTS ARE NORMAL AND THERE IS NO REPORTED PROBLEM IN NORMAL DAILY LIFE. ALTHOUGH THE PATIENT'S SYMPTOMS DO NOT INTERFERE WITH NORMAL DAILY LIFE, THEY ARE REPORTABLY INTERFERING WITH OCCUPATIONAL ACTIVITIES AS A GEOLOGIST. IT IS UNCLEAR WHETHER THE CLAIMED SYMPTOM IS EVER OBSERVED BY THE PATIENT IN LIGHT OUTSIDE THE SCOPE OF LIGHT FROM UV-INDUCED FLUORESCENCE OR IF THERE IS ANY CAUSAL RELATIONSHIP BETWEEN THE TRITON PLUS DEVICE AND THE CLAIMED SYMPTOM.

    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
    1686618 DRI OCT TRITON (PLUS) OPTICAL COHERENCE TOMOGRAPHER OBO TOPCON CORPORATION 470129900

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Disability