BEUDAMED
    FDA Adverse Event Other Summary report: N

    PARAGON CRT

    MDR report key: 519597 · Received April 7, 2004

    Report

    Report Number
    2020433-2004-00001
    Event Type
    Other
    Date Received
    April 7, 2004
    Date of Event
    January 11, 2004
    Report Date
    March 5, 2004
    Manufacturer
    PARAGON VISION SCIENCES
    Product Code
    LPL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    EYE EXAM IN 2003. CRT FITTING THE FOLLOWING MONTH. SUCCESSFULLY COMPLETED CRT PROGRAM 27 DAYS LATER. VISION: OD 20/25 NEAR--- DISTANCE OS 20/25: 20/30 MONOVISIION LEFT EYE NEAR. DR SAW PT IN 2004. DISCOMFORT AND SLIGHTLY SWOLLEN EYELIDS UPON WAKING THE DAY BEFORE. NIGHT OF EVENT DATE UNABLE TO SLEEP DUE TO PAIN. CALLED DR THE FOLLOWING DAY IN THE EARLY MORNING. THERE WAS A LARGE ULCERATION OF THE CORNEA OVER THE PUPIL AREA EXTENDING UP TO THE UPPER LIMBUS. SENT TO OMD, CULTURE WAS POSITIVE OF PSEUDOMONAS AERUGINOSA, SUSCEPTIBLE TO TOBRAMYCIN AND CILOXIN. TX: VIGAMOX 1GTT EVERY MINUTE UNTIL ARRIVE AT OMD'S OFFICE. OMD CONTINUE VIGAMOX 1 30 MINUTES WAKING AND Q 1 HOUR WHEN SLEEPING CILOXIN OINTMENT FOR SLEEPING. CHANGED TO FORTIFIED ANTIBIOTICS VANCOMYCIN AND TOBRAMYCIN Q 30 MINUTES WAKING, 1 HR "WLOOTING", ORAL CIPROFLOXACIN 500MG BID, HOMATROPINE CULTURE CAME BACK SUSCEPTIBLE TO TOBRAMYCIN. THIS TOOK OVER 5 WEEKS TO END THE INFECTIOUS PROCESS. THEN STEROID TREATMENT WAS STARTED. ON LAST REPORT VISION HAD STARTED TO IMPROVE TO 20/70. TREATMENT IS CONTINUING, HOPEFULLY PT'S VISION WILL IMPROVE.

    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 48 YR Required Intervention