BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RXSIGHT CONTACT LENS

    MDR report key: 22761774 · Received August 8, 2025

    Report

    Report Number
    3012712027-2025-00303
    Event Type
    Injury
    Date Received
    August 8, 2025
    Report Date
    August 8, 2025
    Manufacturer
    RXSIGHT, INC.
    Product Code
    HJK
    PMA / PMN Number
    K201909
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REFERENCE #: (B)(4).

    Description of Event or Problem · 0

    RXSIGHT BECAME AWARE OF A PATIENT WHO DEVELOPED CORNEAL ULCERS. THE PATIENT ATTRIBUTES THE CORNEAL ULCERS TO A "MISHANDLING" OF THE CONTACT LENS USED DURING LIGHT TREATMENT. THE PATIENT ALSO NOTES THAT THE DOCTOR OR CLINIC ATTRIBUTES THE CORNEAL ULCERS TO THE PATIENT'S ANTERIOR BASEMENT MEMBRANE DYSTROPHY (ABMD).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757428 RXSIGHT CONTACT LENS DIAGNOSTIC CONTACT LENS HJK RXSIGHT, INC. 62020

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention