BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSEPT QUICK DISINFECTING SOLN (DEVICE 1)

    MDR report key: 1911765 · Received November 24, 2010

    Report

    Report Number
    2020664-2010-00122
    Event Type
    Injury
    Date Received
    November 24, 2010
    Date of Event
    April 1, 2010
    Report Date
    October 29, 2010
    Manufacturer
    ADVANCED MEDICAL OPTICS, INC.
    Product Code
    LPN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SEE RELATED MDR 2020664-2010-00123 FOR DEVICE 2 NEUTRALIZING SOLUTION. SEE MDRS 2020664-2010-00124 (DISINFECTING SOLUTION) AND 2020664-2010-00125 (NEUTRALIZING SOLUTION) FOR PT #2. MUTOH T, ISHIKAWA I, MATSUMOTO Y, CHIKUDA M. CLINICAL OPHTHALMOLOGY 2010: 4 1189-1192.

    Description of Event or Problem · 1

    A LITERATURE ARTICLE PROVIDED DETAILS REGARDING 9 CASES OF ACANTHAMOEBA KERATITIS. TWO OF THE CASES INVOLVED PTS USING CONSEPT QUICK DISINFECTING AND NEUTRALIZING SYSTEM. PT ONE IS A (B)(6) FEMALE, WHO WORE PLANNED REPLACEMENT CONTACT LENSES (MONTHLY FINE). DIAGNOSIS WAS MADE BY DIRECT LIGHT MICROSCOPY OF CORNEAL SPECIMENS STAINED BY THE PARKER INK-POTASSIUM HYDROXIDE METHOD BETWEEN (B)(6) 2006 AND (B)(6) 2009. PT OCCASIONALLY WORE LENSES LONGER THAN RECOMMENDED AND WASHED CONTACT LENS CASE WITH TAP WATER. TREATMENT CONSISTED OF ANTIFUNGAL EYE DROPS (0.2% FLUCONAZOLE, 0.1% MICRONAZOLE, 0.1% MICAFUNGIN SODIUM (ONE OR TWO DRUGS), SYSTEMIC ANTIFUNGAL THERAPY (ORAL ITRACONAZOLE 200 MG/DAY) AND SURGICAL DEBRIDEMENT. THIS PT HAD 14 CORNEAL DEBRIDEMENTS. THE PT SHOWED IMPROVEMENT OF VISUAL ACUITY TO 1.0 BY 3 WEEKS AFTER THE START OF TREATMENT AND NO AMOEBAE WERE FOUND IN THE CORNEAL SCRAPINGS AFTER 6 WEEKS OF TREATMENT; SHE WAS JUDGED TO BE CURED AND TREATMENT WAS STOPPED. HOWEVER, ONE MONTH LATER, THE KERATITIS RECURRED AND PROGRESSED TO THE COMPLETE STAGE. VISUAL ACUITY FOLLOWING TREATMENT WAS UNCHANGED FROM BASELINE (0.5).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSEPT QUICK DISINFECTING SOLN (DEVICE 1) LPN ADVANCED MEDICAL OPTICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention MONTHLY FINE SOFT CONTACT LENSES