BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARAGON CRT 100

    MDR report key: 19822189 · Received July 24, 2024

    Report

    Report Number
    3013398957-2024-12095
    Event Type
    Injury
    Date Received
    July 24, 2024
    Date of Event
    June 1, 2024
    Report Date
    June 26, 2024
    Manufacturer
    PARAGON VISION SCIENCES, INC.
    Product Code
    NUU
    UDI-DI
    B222180
    PMA / PMN Number
    P870024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT IS NOT RETURNED BU THE PATIENT FOR INSPECTION/INVESTIGATION. REVIEW OF THE DEVICE HISTORY RECORD FOUND THAT THE QUALITY CONTROL (QC) BATCH MET RELEASE REQUIREMENTS AT THE TIME OF MANUFACTURE. ON JULY 12, 2024, FOLLOW-UP EMAILED STATED, PATIENT HAS DECIDED TO DISCONTINUE ORTHO-K LENS UNTIL EYES FULLY HEAL. AND DOES NOT WANT TO SEE THE CORNEAL SPECIALIST.

    Description of Event or Problem · 0

    DURING ROUTINE EXAMINATION THE DOCTOR FOUND THE FOLLOWING: SLE: STIPPLE/SPK EPITHELIAL DISRUPTION IN ARCUATE PATTERN, WHITE SPOT POSSIBLY IN STROMA. THE PATIENT DID NOT PRESENT ANY VISUAL DISTURBANCE. PATIENT HAD NO PAIN OR DISCOMFORT. THE DOCTOR DISCONTINUED LENS WEAR FOR TWO WEEKS AND PRESCRIBED STEROIDS. IN THE FOLLOW UP APPOINTMENT AFTER 2 WEEKS, STIPPLE/SPK AND EPITHELIUM STAINING WERE RESOLVED. WHITE SPOTS REMAINED. THE DOCTOR ORDERED A NEW LEFT LENS WITH FLATTER LZA 360 DEGREES. AFTER CONSULTANT DISCUSSED WITH PRACTITIONER LEAH JOHNSON, OD. IT WAS DETERMINED TO DISCONTINUE LENS WEAR AGAIN AND SCHEDULE AN APPOINTMENT WITH A CORNEAL SPECIALIST. ORTHO - K LENS WEAR WILL BE CONSIDERED WHEN AUTHORIZED BY CORNEAL SPECIALIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2370905 PARAGON CRT 100 ORTHOKERATOLOGY LENSES NUU PARAGON VISION SCIENCES, INC. B222180

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention