BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARAGON CRT 100

    MDR report key: 19289004 · Received May 10, 2024

    Report

    Report Number
    3013398957-2024-12072
    Event Type
    Injury
    Date Received
    May 10, 2024
    Date of Event
    April 11, 2024
    Report Date
    May 10, 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
    AZ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON 5/2/2024, THE MANUFACTURER WAS INFORMED THAT THE PATIENT HAS FULLY RECOVERED. THE DOCTOR RE-ORDERED A NEW PAIR AND RE-EVALUATED. LENS FIT HAD TO BE ADJUSTED FOR NEW PAIR. THE LENS WAS NOT RETURNED FOR FURTHER INVESTIGATION. REVIEW OF THE DEVICE HISTORY RECORD FOUND THAT THE QUALITY CONTROL (QC) BATCH MET RELEASE REQUIREMENTS AT THE TIME OF MANUFACTURE.

    Description of Event or Problem · 0

    PATIENT HAD AN ULCER IN OS. DR THINKS THERE WERE OUTSIDE FACTORS INVOLVED AND NOT CERTAIN IT WAS THE LENSES. THE LNESES WERE OLDER AND FIT WELL LAST CHECK. REORDERING A FRESH PAIR AND RE-EVALUATING. THE DR PRESCRIBED VIGAMOX EYE DROPS. ONE DROP EVERY 4 HOURS FOR THE FIRST 24 HOURS AND THEN 4X A DAY FOR A WEEK. DR DISCONTINUED LENS WEAR TO HEAL AND WILL RECHECK IN ABOUT A WEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2498717 PARAGON CRT 100 Lens, contact, orthokeratology, overnight NUU PARAGON VISION SCIENCES, INC. B222180

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other