BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVU

    MDR report key: 1100548 · Received August 4, 2008

    Report

    Report Number
    MW5007894
    Event Type
    Injury
    Date Received
    August 4, 2008
    Report Date
    August 4, 2008
    Manufacturer
    JOHNSON AND JOHNSON
    Product Code
    LPL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS IS A PROBLEM WITH OASYS CONTACT LENSES MANUFACTURED BY JOHNSON AND JOHNSON. I HAVE DEVELOPED A RECURRING CORNEAL ULCER IN MY LEFT EYE REFRACTORY TO TREATMENT. I HAVE BEEN WEARING CONTACT LENSES FOR CLOSE TO 20 YEARS WITHOUT EVER HAVING ANY PROBLEMS. I AM COMPULSIVE ABOUT FOLLOWING THE GUIDELINES AS I AM A RADIOLOGIST AND MY VISION IS MY LIVELIHOOD. I HAVE NEVER SLEPT WEARING MY LENSES. IN 2008, AFTER AN UNUSUAL INSISTENCE ON THE SIDE OF AN OPTOMETRIST, I SWITCHED TO OASYS. I DEVELOPED A CORNEAL ULCER IN MY LEFT EYE IN FOUR MONTHS LATER. THE ULCER QUICKLY HEALED USING ZYMAR ANTIBIOTIC DROPS. I BECAME MORE METICULOUS THAN EVER CHANGING MY SOLUTION ETC AND WORE GLASSES FREQUENTLY. THE CORNEAL ULCER RECURRED IN THE FOLLOWING MONTH. THIS TIME AROUND, AFTER THREE WEEKS ONLY A LITTLE PROGRESS USING VIGAMOX AND SUBSEQUENTLY ZYMAR DROPS AND WEARING GLASSES. DOSE OR AMOUNT: ONE LENS EACH EYE WORKING HRS. FREQUENCY: EVERY TWO WEEKS. DATES OF USE: 2008. DIAGNOSIS OR REASONS FOR USE: MYOPIA. EVENT ABLATED AFTER USE STOPPED OR DOSE REDUCER: YES. EVENT REAPPEARED AFTER REINTRODUCTION: YES. FIRST TREATMENT FOR CORNEAL ULCER, LT EYE: 2008. EYE CARE ASSOCIATES DR, OPTOMETRIST. ULCER RECURRENCE: 2008. MULTIPLE VISITS WITH DR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUVU OASYS D -4.00 LPL JOHNSON AND JOHNSON 2127080583

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Disability