BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAIRA TORIC (ENFILCON A)

    MDR report key: 2754672 · Received September 20, 2012

    Report

    Report Number
    2640128-2012-00023
    Event Type
    Injury
    Date Received
    September 20, 2012
    Report Date
    August 22, 2012
    Manufacturer
    COOPER VISION CARRIBBEAN CORP
    Product Code
    LPL
    PMA / PMN Number
    K071736
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PT WAS SEEN BY THE EYE CARE PRACTITIONER (ECP) ON (B)(6) 2012 FOR A SWOLLEN AND RED RIGHT EYE AND EXTREME PAIN. THE DOCTOR CHECKED HER AND SHE HAD A LARGE SCRATCH ON HER CORNEA. THE PT RETURNED ON (B)(6) 2012, HER EYE WAS STILL SWOLLEN AND RED AND SHE WAS STILL IN EXTREME PAIN, THE DOCTOR SENT HER TO AN OPHTHALMOLOGIST. THE OPHTHALMOLOGIST STATES THE PT HAD PHOTO PHOBIA, THE CORNEAL ABRASION HEALED 2 DAYS LATER AND THAT THE PT STILL HAD EDEMA AND UVEITIS. HE STATES THAT IT WAS NOT ASSOCIATED WITH THE LENSES THAT IT WAS AN OVER WEARING ISSUE WITH CORNEAL EDEMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVAIRA TORIC (ENFILCON A) LPL, SOFT CONTACT LENS, DAILY WEAR LPL COOPER VISION CARRIBBEAN CORP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other