BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARAGON CRT DUAL AXIS

    MDR report key: 17347383 · Received July 18, 2023

    Report

    Report Number
    3013398957-2023-11926
    Event Type
    Injury
    Date Received
    July 18, 2023
    Date of Event
    January 11, 2023
    Report Date
    July 18, 2023
    Manufacturer
    PARAGON VISION SCIENCES, INC.
    Product Code
    NUU
    PMA / PMN Number
    P870024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LENS SERIAL NUMBER THE PATIENT WAS WEARING AT THE TIME OF THE INCIDENT: (B)(6). THE SALES ORDER FOR THAT LENS WAS: SO00418307 (SHIPPED 12/20/2022). ECP ORDERED NEW LENS WITH FLATTER LZA, SO00423689 (SHIPPED 1/13/23).

    Description of Event or Problem · 0

    PATIENT DEVELOPED MILD ULCER IN OD. THE ULCER WAS LOCATED INFERIOR TEMPORAL IN THE TREATMENT ZONE BUT OUTSIDE OF THE VISUAL AXIS. THE DR PRESCRIBED MOXIFLOXACIN AND DISCONTINUED USE AS OF (B)(6) 2023. THE PATIENT HAD DECREASED VISUAL ACUITY AS A RESULT BUT THE DR EXPECTS THERE TO BE NO PERMANENT DAMAGE OR ALTERING OF THE CORNEA. THE DR REPORTED TIGHT EDGES AND REORDERED LENS WITH FLATTER LZA. THE ECP INDICATED THAT THE CORNEA HAD FULLY HEALED AND THEIR VA WAS BACK TO WHAT IT NORMALLY WAS UNCORRECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1124326 PARAGON CRT DUAL AXIS ORTHOKERATOLOGY, CONTACT LENS NUU PARAGON VISION SCIENCES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention