BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARAGON CRT DUAL AXIS

    MDR report key: 11617250 · Received April 6, 2021

    Report

    Report Number
    2020433-2021-00019
    Event Type
    Injury
    Date Received
    April 6, 2021
    Date of Event
    March 12, 2021
    Report Date
    March 30, 2021
    Manufacturer
    PARAGON VISION SCIENCES, INC.
    Product Code
    NUU
    PMA / PMN Number
    P870024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD A PERIPHERAL ULCER ON OS POSSIBLY DUE TO FOREIGN SUBSTANCE OR SCRATCH ON THE LENS. PATIENT HAD NO PAIN, JUST SOME PHOTOSENSITIVITY IN THE AFFECTED EYE. THE PATIENT WAS TREATED WITH BESIVANCE AND LOTOMAX. THE PATIENT'S EYS HAS COMPLETELY HEALED, WITH NO SCARRING OR LOSS OF VISUAL ACUITY. THE PAIENT IS BACK TO WEARING PARAGON CRT LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    516127 PARAGON CRT DUAL AXIS ORTHO-K LENS NUU PARAGON VISION SCIENCES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Required Intervention