BEUDAMED
    FDA Adverse Event Other Summary report: N

    PARAGON CRT

    MDR report key: 519513 · Received April 7, 2004

    Report

    Report Number
    2020433-2004-00002
    Event Type
    Other
    Date Received
    April 7, 2004
    Date of Event
    July 30, 2003
    Report Date
    March 5, 2004
    Manufacturer
    PARAGON VISION SCIENCES
    Product Code
    LPL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PATIENT PRESENTED IN 2003 COMPLAINING OF A RED, PAINFUL EYE, WITH FOREIGN BODY SENSATION OS SINCE LAST NIGHT SHORTLY AFTER INSERTING THEIR ORTHOKERATOLOGY LENSES. THE PATIENT REPORTED THE EYE HAS FELT INCREASINGLY UNCOMFORTABLE SINCE SWIMMING IN A LOCAL WATER PARK YESTERDAY AND FELT A FOREIGN BODY SENSATION AFTER INSERTING THEIR PARAGON CRT LENSES THE PREVIOUS NIGHT. THE PATIENT REMOVED AND CLEANED THE LENSES, THEN CONTINUED WEAR. BIOMICROSCOPY SHOWED 1 + SPK OD AND A SMALL 1-2MM CENTRAL CORNEAL ABRASION OS. LENS WEAR WAS DISCONTINUED AND POLYTRIM OPHTHALMIC SOLUTION QID OU WAS PRESCRIBED. ONE DROP 1% CYCLOPENTOLATE OS WAS GIVEN IN OFFICE FOR DISCOMFORT. NO CELLS WERE NOTED IN THE ANTERIOR CHAMBER AND NO CORNEAL INFILTRATES WERE SEEN. THE PATIENT WAS ASKED TO RETURN TO THE CLINIC IN 24HRS TO MONITOR THE AREA. ONE DAY LATER THE PATIENT REPORTED NO IMPROVEMENT AND MUCH MORE PHOTOPHOBIA. BIOMICROSCOPY SHOWED A 1 MM ROUND ULCER CNETRALLY OS. THE PATIENT WAS TREATED WITH CILOXAN SOLUTION 1 DROP EVERY HOUR, CILOXAN OINTMENT QHS OS, AND 1% CYCLOPENTOLATE TID OS. THE PATIENT'S CONTACT LENSES AND CASE WERE SENT FOR BACTERIAL CULTURING. CULTURES SHOWED NO SIGNIFICANT BACTERIAL GROWTH. THE PATIENT WAS MONITORED DAILY AND SLIGHT IMPROVEMENT WAS NOTED ON DAY THREE. THE PATIENT'S EPITHELIAL DEFECT HEALED COMPLETELY BY DAY SEVEN AND WAS SWITCHED TO TOBRADEX OPHTHALMIC SOLUTION QID FOR TWO WEEKS TO REDUCE ANY RESIDUAL INFLAMMATION AND MINIMIZE SCARRING. SIX WEEKS AFTER THE INITIAL PRESENTATION THE PATIENT'S BCVA WAS 20/20 OD AND OS. THE PATIENT WAS ALLOWED TO START WEARING THEIR OVERNIGHT ORTHOKERATOLOGY LENSES AGAIN AND HAS HAD NO FURTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARAGON CRT CONTACT LENS FOR CORNEAL REFRACTIVE THERAPY LPL PARAGON VISION SCIENCES * *

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention