BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS

    MDR report key: 667057 · Received January 23, 2006

    Report

    Report Number
    1313525-2006-00004
    Event Type
    Injury
    Date Received
    January 23, 2006
    Report Date
    December 28, 2005
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    MUW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A PATIENT DEVELOPED ACANTHAMOEBA KERATITIS DURING ORTHOKERATOLOGY FOR MYOPIC REDUCTION. PATIENT WAS WEARING OVERNIGHT RIGID GAS PERMEABLE (OPRIFOCON A) REVERSE GEOMETRY CONTACT LENSES WHEN SHE DEVELOPED DISCOMFORT IN THE RIGHT EYE. THE DISCOMFORT PROGRESSED OVER ONE MONTH DESPITE ANTIBACTERIAL AND COIRTICOSTEROID EYE DROPS. AT REFERRAL, PATIENT PRESENTED WITH HAND MOTIONS VISION AND A RING-SHAPEED STROMAL INFILTRATE. A CORNEAL BIOPSY REVEALED AMOEBIC CYSTS BY HISTOPATHOLOGICAL EVALUATION. ACANTHAMEOBA SPECIES WERE ISOLATED ON BUFFERED CHARCOAL-YEAST EXTRACT AGAR FROM CORNEAL SCRAPINGS AND FROM THE CONTACT LENS. AFTER SIX MONTHS OF TOPICAL ANTIPROTOZOAL THERAPY, VISUAL ACUITY HAD IMPROVED. ONE YEAR LATER, PENETRATING KERATOPLASTY WAS PERFORMED. THE CORNEAL BUTTON WAS THINNED AND SCARRED BUT HAD NO OBSERVABLE CYSTS. POSTKERATOPLASTY VISUAL ACUITY IMPROVED TO 20/20.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS GAS PERMEABLE CONTACT LENS MUW BAUSCH & LOMB, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention