BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURESIGHT

    MDR report key: 21170512 · Received January 16, 2025

    Report

    Report Number
    MW5164849
    Event Type
    Injury
    Date Received
    January 16, 2025
    Date of Event
    December 18, 2024
    Report Date
    January 12, 2025
    Manufacturer
    NOVASIGHT
    Product Code
    QQU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    AFTER MY SON USED THE CURESIGHT DEVICE FOR AMBPLEOPIA TREATMENT, HE STARTED EXPERIENCING SEVERE EYE PAIN, BLURRED VISION, AND A POUNDING HEADACHE. HIS VISION GOT WORSE, AND HE BEGAN VOMITING UNCONTROLLABLY. WE REACHED OUT TO HIS OPHTHALMOLOGIST, WHO ADVISED US TO STOP USING THE DEVICE IMMEDIATELY AND REPORT THE INCIDENT. WE ALSO TRIED CONTACTING THE VENDOR, BUT THE ONLY RESPONSE WE GOT WAS FROM AN UNRELATED CALL CENTER THAT REFUSED TO PROVIDE ANY REAL ANSWER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1056613 CURESIGHT DIGITAL THERAPY DEVICE FOR AMBLYOPIA QQU NOVASIGHT CS 100

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Male Hospitalization| R