BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAIRA TORIC (ENFILCON A)

    MDR report key: 2393042 · Received December 22, 2011

    Report

    Report Number
    2640128-2011-00074
    Event Type
    Injury
    Date Received
    December 22, 2011
    Report Date
    October 17, 2011
    Manufacturer
    COOPER VISION CARRIBBEAN CORP
    Product Code
    LPL
    PMA / PMN Number
    K071736
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS BEING FILED AS A CORNEAL ULCER. METHOD - NO LENSES, NO EXAMINATION OF DEVICE WERE PROVIDED WHICH COULD INDICATE IF THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT. RESULTS - THERE IS NO CLEAR INDICATION THAT THE DEVICE COULD HAVE CAUSED OR CONTRIBUTED TO THE INCIDENT. CONCLUSION - THERE IS NOT SUFFICIENT INFO PROVIDED TO DRAW A CONCLUSION AS TO WHETHER OR NOT THE DEVICE COULD HAVE CAUSED OR CONTRIBUTED TO THE PT'S COMPLAINT. NO CONCLUSION CAN BE DRAWN. SHOULD FURTHER INFO BE PROVIDED THAT WOULD CHANGE THIS CONCLUSION, AN UPDATE TO THIS REPORT WILL BE PROVIDED WITHIN ONE MONTH OF RECEIPT OF THE ADD'L INFO.

    Description of Event or Problem · 1

    THE PT ORIGINALLY REPORTED A "SCRATCHED CORNEA" AND WAS GIVEN ANTIBIOTICS AND DROPS FOR THE PAIN. NEW INFO BECAME AVAILABLE ON DECEMBER 21, 2011. THE TREATING FACILITY (B)(6) MEDICAL CENTER STATED THAT THE PT HAD AN ULCERATED AREA AND THE DOCTOR BELIEVES IT WAS FROM OVER WEARING OF THE LENSES. ATTEMPTS TO CONTACT THE PT AND THE ECP FOR MORE INFO HAVE BEEN MADE WITH NO REPLY AS OF TO DATE. THIS IS BEING FILED AS A CORNEAL ULCER.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other