BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUVUE OASYS

    MDR report key: 3202278 · Received June 26, 2013

    Report

    Report Number
    MW5030704
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    May 9, 2013
    Report Date
    June 26, 2013
    Manufacturer
    JOHNSON AND JOHNSON VISION CARE
    Product Code
    LPL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT ARRIVED IN CLINIC WITH SEVERE EYE PAIN. PT PUT ON NEW PAIR OF CONTACT LENSES THE DAY PRIOR. PT STATES VISION WAS NOT AS CLEAR AS USUAL AND THE CONTACTS DID NOT FEEL QUITE RIGHT. PT WORE CONTACTS THROUGHOUT THE DAY AND THEN REMOVED THEM AT 8:00 PM. OVER THE EVENING, PT HAD PROGRESSIVELY INCREASING DISCOMFORT. PHYSICIAN EYE EXAM NOTES DESCRIBE EXTENSIVE CORNEAL ABRASIONS IN BOTH EYES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290273 ACUVUE OASYS RIGHT EYE: -0.75X070 LPL JOHNSON AND JOHNSON VISION CARE B00DNXW047
    290274 ACUVUE OASYS LEFT EYE: -0.75X100 LPL JOHNSON AND JOHNSON VISION CARE B00CG8L2MC

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other