BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARAGON CRT100

    MDR report key: 12457679 · Received September 11, 2021

    Report

    Report Number
    3013398957-2021-00001
    Event Type
    Injury
    Date Received
    September 11, 2021
    Date of Event
    January 1, 2021
    Report Date
    September 10, 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

    THE PATIENT WAS FITTING WITH PARAGON CRT100 LENS ON (B)(6) 2019 AND COMPLETED ALL FOLLOW UPS UNTIL HIS ANNUAL. HIS FATHER STATED DUE TO COVID-19, HE FORGOT ABOUT THE ANNUAL FOLLOW UP. WHEN THE PATIENT WAS SEEN IN (B)(6) 2021, HE HAD PAIN IN HIS RIGHT EYE AND SOME WHITE RESIDUE WAS NOTICED ON THE LENS. THE LENS WAS ABOUT 1.5 YEARS OLD. THE CORNEA LOOKED TO HAVE INFILTRATES PER THE DOCTOR. THE PATIENT WAS TREATED WITH RETAINER AND TOBRADEX. THE RIGHT CORNEA IMPROVED ABOUT 50% BUT THERE WAS STILL A FLAT WHITE FAINT SCAR AFTER A MONTH OF TREATMENT. HIS BCVA IS 20/40. THE DOCTOR SUSPECTED THE WHITE RESIDE IS FROM THE CLEANING SOLUTION WITH CHLORHEXISTINE PRESERVATIVE. PARAGON CRT100 WEAR HAS BEEN PERMANENTLY DISCONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1355134 PARAGON CRT100 ORTHO-K CONTACT LENS NUU PARAGON VISION SCIENCES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention| S