BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAIRA TORIC (ENFILCON A)

    MDR report key: 2873746 · Received December 14, 2012

    Report

    Report Number
    2640128-2012-00028
    Event Type
    Injury
    Date Received
    December 14, 2012
    Date of Event
    November 17, 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. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    ON (B)(6) 2011, PATIENT WENT TO DOCTORS OFFICE WITH COMPLAINT OF GREEN DISCHARGE FROM EYES. NO COMPLAINTS OF VISUAL DISTURBANCE. PATIENT STATED SHE APPLIED MAKE UP AND HAD SOME REDNESS AFTER SHE USED IT. LEFT CONJUNCTIVAL PURULENT DISCHARGE, LEFT CONJUNCTIVAL ERYTHEMA AND HAS HARD TIME FULLY OPENING LEFT EYE. ON (B)(6) 2011, PATIENT FOLLOW UP AT NEW DOCTOR. PATIENT SLEPT IN LENSES FROM SUNDAY AND WERE IN THE EYES THE ENTIRE TIME UNTIL WEDNESDAY. DIAGNOSED WITH CENTRAL CORNEA ULCER - LEFT EYE. PRESCRIBED FORTIFIED CEFAZOLIN QIH, FORTIFIED CEFAZOLIN Q1H, SCOPOLAMINE BID. ON (B)(6) 2011 - PATIENT SEEN FOR FOLLOW UP VISION. PRESCRIBED BACITRACIN OINTMENT, FORTIFIED CEFAZOLIN, FORTIFIED TOBRAMYCIN. ON (B)(6) 2011 FOLLOW UP, PATIENT IS BETTER, DECREASED PAIN, DECREASED PHOTOPHOBIA, EYE IS STILL RED. ON (B)(6) 2011 FOLLOW UP, COMPLAINTS OF RED EYE. VA (VISUAL ACUITY) IMPROVEMENT. ON (B)(6) 2011, 8 DAY FOLLOW UP. EYE FEELS BETTER. ON (B)(6) 2011 FOLLOW UP PATIENT HAS A PARA CENTRAL STROMAL SCAR.

    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.

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention