BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOSTON ORTHO-K (OPRIFOCON A) SHAPING LENS

    MDR report key: 1738433 · Received June 22, 2010

    Report

    Report Number
    1313525-2010-00009
    Event Type
    Injury
    Date Received
    June 22, 2010
    Report Date
    June 4, 2010
    Manufacturer
    BAUSCH + LOMB
    Product Code
    MUW
    PMA / PMN Number
    K003933
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER AND NO LOT NUMBER INFORMATION WAS PROVIDED. HOWEVER, THE DOCTOR STATED THAT IRREGULAR CLEANING AND DISINFECTING OF LENSES, ALONG WITH THE USE OF TAP WATER DURING LENS CLEANING BY THE PATIENT, SEEMED TO HAVE CAUSED THE EVENT. BASED ON ALL INFORMATION, NO CAUSAL FACTORS CAN BE DETERMINED, AND NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    PATIENT PRESENTED TO A LOCAL CLINIC WITH SYMPTOMS OF OCULAR PAIN, LIGHT SENSITIVITY, AND DECREASED VISION IN BOTH EYES, AFTER WEARING ORTHOKERATOLOGY CONTACT LENSES OVER NIGHT FOR FIVE DAYS. THE PATIENT WAS DIAGNOSED AS HAVING BILATERAL INFECTIOUS CORNEAL ULCERS, WITH EITHER VIRAL OR FUNGAL KERATITIS. THE PATIENT WAS TREATED WITH ANTIVIRAL AND ANTIFUNGAL MEDICATIONS. APPROXIMATELY ONE MONTH LATER, THE PATIENT PRESENTED TO A HOSPITAL DOCTOR, AS SYMPTOMS CONTINUED AFTER ONE MONTH OF TREATMENT. THE PATIENT WAS DIAGNOSED AS HAVING (B)(6) INFECTION, WITH A SECONDARY BACTERIAL INFECTIONS. THE PATIENT WAS TREATED WITH ANTIPROTOZOAL, ANTIBIOTIC, AND ANTI-INFLAMMATORY THERAPY. AFTER ONE MONTH OF TREATMENT, THE CORNEAL ULCER HAD HEALED, AND THE PATIENT'S BEST CORRECTED VISUAL ACUITY WAS 20/100 OD AND 20/25 OS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON ORTHO-K (OPRIFOCON A) SHAPING LENS MUW BAUSCH + LOMB

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention