BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAIRA TORIC (ENFILCON A)

    MDR report key: 2873855 · Received December 14, 2012

    Report

    Report Number
    2640128-2012-00026
    Event Type
    Injury
    Date Received
    December 14, 2012
    Date of Event
    September 27, 2011
    Report Date
    November 14, 2012
    Manufacturer
    COOPERVISION CARIBBEAN CORP.
    Product Code
    LPL
    PMA / PMN Number
    K071736
    Removal / Correction Number
    Z-0044-2012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    NO LENSES WERE RETURNED FOR EVALUATION. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PATIENT REPORTEDLY WENT TO THE EMERGENCY ROOM WITH COMPLAINTS OF RIGHT EYE PAIN / BLURRED VISION. THE PATIENT REPORTS THAT SHE FELT LIKE SOMETHING WAS IN THE EYE, PUT SOME DROPS IN AND LATER THAT EVENING UPON REMOVING CONTACTS, HAD SUDDEN EXTREME PAIN, BLURRED VISION, TEARING, PHOTOPHOBIA, SCLERA RED. THE RESIDENT /NP ASSESSMENT PLAN - LARGE CORNEAL ABRASION. ON (B)(6) 2011, CORNEAL FLUORESCENE UPTAKE ON EXAM CONSISTENT CORNEAL ULCER. EMERGENCY DEPARTMENT DIAGNOSIS - CORNEAL ULCER. PRESCRIBED MOXIFLOXICIN, BACITRACIN/POLYMIXIN, OXYCODONE/ACETAMINOPHEN. FOLLOW UP WITH THE M. D. ON (B)(4) 2011, NOTES CONTACT LENS RELATED INJURY (POSSIBLE ABRASION) DIFUSE STROMAL DEPTH 1-2 CELLS AND WAS PRESCRIBED PREDNISOLONE AND POLYTRIM. FOLLOW UP WITH THE M.D. ON (B)(4) 2011, NOTES THE PATIENT STILL HAS BLURRY VISION IRITIS S/P CL ABRASION. FOLLOW UP WITH THE M.D. ON (B)(4) 2011, NOTES VISION IS IMPROVING. FOLLOW UP WITH THE M. D. ON (B)(4) 2011, NOTES BLURRINESS, IMPROVEMENT AND NO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVAIRA TORIC (ENFILCON A) LPL, SOFT CONTACT LENS, DAILY WEAR LPL COOPERVISION CARIBBEAN CORP. 10454500009004

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention