BEUDAMED
    FDA Adverse Event Other Summary report: N

    AVAIRA SPHERE

    MDR report key: 3066065 · Received April 15, 2013

    Report

    Report Number
    2640128-2013-00005
    Event Type
    Other
    Date Received
    April 15, 2013
    Date of Event
    September 1, 2011
    Report Date
    March 17, 2013
    Manufacturer
    COOPER VISION CARRIBBEAN CORP
    Product Code
    LPL
    PMA / PMN Number
    K071736
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    COOPERVISION WAS MADE AWARE BY A PT'S PARENTS THAT THEIR DAUGHTER WAS DIAGNOSED WITH IRIDOCYCLITIS/KERATITIS. SYMPTOMS AND DATE OF ONSET WAS (B)(6) 2011: REDNESS, ACHING, TEARING AND BLURRED VISION OD (RIGHT EYE). HOURLY STEROID MEDICATIONS PRESCRIBED FOR OD. NO PERMANENT IMPAIRMENT OF LAST VISIT REPORTED (B)(6) 2011 (TWO MONTHS AFTER EVENT). IT IS UNK WHETHER THE PT HAS PERMANENT DAMAGE TO EYE FUNCTION OR BODY STRUCTURE AS THE PT REFUSED THE REQUESTED FOLLOW-UP APPOINTMENT. THE OPHTHALMOLOGIST REPORTED 20/20 VISION IN EACH EYE. THERE WAS NO CORNEAL INVOLVEMENT IN THIS CASE. NO LENSES WERE RETURNED AND NO LOT NUMBER WERE CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160582 AVAIRA SPHERE LPM, SOFT CONTACT LENS, DAILY WEAR LPL COOPER VISION CARRIBBEAN CORP

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention