BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RXSIGHT CONTACT LENS

    MDR report key: 24006961 · Received January 8, 2026

    Report

    Report Number
    MW5181948
    Event Type
    Injury
    Date Received
    January 8, 2026
    Report Date
    January 6, 2026
    Manufacturer
    RXSIGHT INC.
    Product Code
    HJK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    COMPLAINANT ALLEGES RXSIGHT INC.'S RXSIGHT LIGHT ADJUSTABLE LENS (LAL+) - LIGHT ADJUSTABLE LENS (LAL) AND LIGHT DELIVERY DEVICE (LDD) - WERE NEVER CLINICALLY STUDIED FOR SAFETY AND EFFECTIVENESS. ADDITIONALLY, THE COMPLAINANT COMPLAINED OF BLURRED VISION, DISCOMFORT FROM VARIOUS SOURCES OF LIGHT, DIMINISHED DISTANCE VISION, AND DRY EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63234 RXSIGHT CONTACT LENS LENS, CONTACT, POLYMETHYLMETHACRYLATE, DIAGNOSTIC HJK RXSIGHT INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown