BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARAGON CRT DUAL AXIS

    MDR report key: 19580655 · Received June 21, 2024

    Report

    Report Number
    3013398957-2024-12083
    Event Type
    Injury
    Date Received
    June 21, 2024
    Date of Event
    May 18, 2024
    Report Date
    May 24, 2024
    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
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DURING THE INVESTIGATION IT WAS DISCOVERED THAT A LENS FITTING WAS NOT PROVIDED. WHEN LENSES WERE MANUFACTURED, THE LENSES WERE PLACED IN THE PATIENT'S CUBICLE. THE PATIENT INFORMED PARAGON VISION SCIENCES THAT NO GUIDANCE WAS GIVEN DURING THIS PROCESS AND ASSUMED IT WAS OKAY TO TRY THEM ON THEMSELVES.

    Description of Event or Problem · 0

    PATIENT DESCRIBE "SCRATCHY" SENSATION IN BOTH EYES WHEN PUTTING ON THE LENSES FOR THE 1ST TIME. PATIENT IS A FIRST-TIME WEARER. PATIENT EXPECTED TO FEEL UNCOMFORTABLE. WHEN THE PATIENT WOKE UP THE NEXT DAY, THEY FELT THE LENS ON THE RIGHT EYE MOVING AROUND (CRAWLING IN EYEBALL SENSATION). AFTER REMOVAL OF THE RIGHT EYE LENS, THE EYE WAS RED AND THERE WAS DRAINAGE (CLEAR DRAINAGE) THROUGHOUT SATURDAY (B)(6)2024) AND PROGRESSED TO GETTING THICKER AND MORE YELLOWISH. THE PATIENT WENT TO THE DR. ON (B)(6) 2024 AND TOBRAMYCIN/DEXAME 0.3-0.1% - 1 DROP INTO RIGHT EYE 4 TIMES DAILY FOR 5 DAYS WAS PRESCRIBED. WILL FOLLOW UP ON (B)(6) 2024 FOR PATIENTS' RECOVERY UPDATE. *RECEIVED THE LENS ON 5/13/24 BUT PUT THE LENS IN THE EYE ON (B)(6) 2024. NO IN-PERSON FITTING- PATIENT WAS NOT AWARE IF THERE WAS MORE INSTRUCTION ON WEARING REGARDING THE FITTING PORTION. NO FURTHER GUIDANCE AFTER RECEIVING LENS. DR. (B)(6) PERFORMED EXAM, AND PRESCRIBED ANTIBIOTICS. LEAH- PRESCRIBE RX LENS USING INFORMATION PROVIDED BY DR. (B)(6) (B)(6) 2024 PATIENT HAS FULLY HEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204733 PARAGON CRT DUAL AXIS ORTHOKERATOLOGY LENSES NUU PARAGON VISION SCIENCES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention