BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAIRA TORIC (ENFILCON A)

    MDR report key: 2251308 · Received September 13, 2011

    Report

    Report Number
    2640128-2011-00010
    Event Type
    Injury
    Date Received
    September 13, 2011
    Date of Event
    July 1, 2011
    Report Date
    August 21, 2011
    Manufacturer
    COOPER VISION CARRIBBEAN CORP
    Product Code
    LPL
    PMA / PMN Number
    K071736
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT WAS REPORTED VERBALLY TO SALES REP WHO FORWARDED TO CUSTOMER SERVICE. SEVERAL ATTEMPTS TO OBTAIN ADD'L INFO HAVE NOT BEEN SUCCESSFUL. IT IS UNK WHICH EYE IS INVOLVED IN THE INCIDENT. METHOD: NO EXAMINATION OF DEVICE WAS PROVIDED WHICH COULD INDICATE IF THE DEVICE CAUSED OR CONTRIBUTED TO THE INCIDENT. RESULTS: THERE IS NO DIRECT CAUSAL RELATIONSHIP ESTABLISHED BETWEEN THE MEDICAL DEVICE AND THE INCIDENT THE PT COMPLAINS OF. CONCLUSIONS: NO CONCLUSION CAN BE DRAWN. THIS IS BEING REPORTED AS CORNEAL EDEMA AND IRITIS WITH NO DIRECT CAUSAL RELATIONSHIP ESTABLISHED BETWEEN THE MEDICAL DEVICE AND THE INCIDENT.

    Description of Event or Problem · 1

    AVAIRA TORIC (ENFILCON A) CONTACT LENSES WERE DISPENSED TO THE PT ON (B)(6) 2011. THE PT WAS SEEN THREE TIMES AFTER THAT ON (B)(6). THE PT WAS DIAGNOSED WITH CORNEAL EDEMA AND IRITIS. THE PT TEMPORARILY DISCONTINUED USE AND HAS BEEN ALLOWED TO SLOWLY START TO WEAR LENSES AGAIN AS OF (B)(6), 2011.

    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 5634500219000315

    Patients

    Seq Age Sex Outcome Treatment
    1 Other