BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EYEBOT

    MDR report key: 24364753 · Received February 17, 2026

    Report

    Report Number
    MW5183872
    Event Type
    Injury
    Date Received
    February 17, 2026
    Date of Event
    January 5, 2026
    Report Date
    February 9, 2026
    Manufacturer
    123 SEE
    Product Code
    QTO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    TO WHOM IT MAY CONCERN, I AM WRITING TO REPORT A CONCERN REGARDING THE EYEBOT AUTOMATED VISION TESTING DEVICE AND ITS POTENTIAL TO PROVIDE INACCURATE RESULTS FOR PATIENTS WITH AMBLYOPIA (LAZY EYE), AS WELL AS ITS LACK OF SAFETY GUIDANCE FOR INDIVIDUALS WITH SIGNIFICANT VISION LOSS IN ONE EYE. I HAVE AMBLYOPIA AFFECTING ONE EYE. DURING TESTING WITH THE EYEBOT SYSTEM, MY VISION WAS ASSESSED BINOCULARLY, AND THE DEVICE GENERATED A PRESCRIPTION STATING THAT I HAVE 20/25 VISION IN BOTH EYES. BASED ON THIS RESULT, THE SYSTEM DID NOT IDENTIFY REDUCED VISION IN ONE EYE AND DID NOT RECOMMEND ANY SPECIAL PRECAUTIONS. HOWEVER, WHEN I LATER VISITED MY EYE DOCTOR FOR A COMPREHENSIVE EXAMINATION, I WAS INFORMED THAT I ACTUALLY HAVE 20/100 VISION IN MY AMBLYOPIC EYE. MY DOCTOR CONFIRMED THAT THIS REDUCED VISION IS LONGSTANDING AND RELATED TO AMBLYOPIA. THIS INDICATES THAT THE EYEBOT DEVICE FAILED TO ACCURATELY DETECT OR ACCOUNT FOR MONOCULAR VISION IMPAIRMENT WHEN TESTING BINOCULARLY. ADDITIONALLY, BECAUSE THE DEVICE DID NOT RECOGNIZE THAT I RELY HEAVILY ON ONE "BETTER" EYE, IT DID NOT SUGGEST THE USE OF IMPACT-RESISTANT OR SAFETY LENSES TO PROTECT THAT EYE. FOR PATIENTS WITH AMBLYOPIA OR SIGNIFICANT VISION LOSS IN ONE EYE, PROTECTING THE BETTER-SEEING EYE IS AN IMPORTANT SAFETY CONSIDERATION. I AM CONCERNED THAT BINOCULAR-ONLY TESTING MAY MASK SERIOUS UNILATERAL VISION DEFICITS, POTENTIALLY LEADING TO INCORRECT PRESCRIPTIONS AND MISSED SAFETY RECOMMENDATIONS. THIS COULD PLACE PATIENTS AT RISK, PARTICULARLY THOSE WHO ARE UNAWARE OF THEIR UNDERLYING CONDITION OR WHO RELY ON AUTOMATED TESTING WITHOUT FOLLOW-UP CLINICAL EVALUATION. I AM SUBMITTING THIS REPORT SO THE FDA CAN EVALUATE WHETHER EYEBOT'S TESTING METHODOLOGY, LABELING, AND PATIENT GUIDANCE ADEQUATELY ADDRESS INDIVIDUALS WITH AMBLYOPIA OR OTHER UNILATERAL VISION IMPAIRMENTS. THANK YOU FOR YOUR ATTENTION TO THIS MATTER. MY DOCTOR IS AN OPTOMETRIST FROM A VERY GOOD SCHOOL AND HE HAS BEEN IN HIS OFFICE FOR 26 YEARS AND HE SAID THAT THIS IS A "DANGEROUS AND UNETHICAL" WAY TO TEST PEOPLE FOR GLASSES!

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422067 EYEBOT DIGITAL VISUAL ACUITY TEST QTO 123 SEE

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention