BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAIRA SHPHERE (ENFILCON A)

    MDR report key: 2425857 · Received January 16, 2012

    Report

    Report Number
    2640128-2011-00090
    Event Type
    Injury
    Date Received
    January 16, 2012
    Report Date
    November 22, 2011
    Manufacturer
    COOPERVISION CARRIBBEAN CORP.
    Product Code
    LPL
    PMA / PMN Number
    K071736
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS BEING FILED AS CORNEAL ULCER. THIS COMPLAINT WAS FILED ON THE WRONG MANUFACTURING NUMBER. IT WAS REPORTED AS (B)(4) 9614392-2011-00126 ON (B)(4) 2011. MFR: COOPERVISION MANUFACTURING (B)(4). THE CORRECT DATA SHOULD BE (B)(4) 2640128-2011-00090 AND IS REFLECTED IN THIS REPORT. METHOD: NO EXAMINATION OF DEVICE WERE 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. CONCLUSIONS: NO CONCLUSION CAN BE DRAWN. TO DATE THERE IS NO CONFIRMATION OF TREATMENT OR OUTCOME OF TREATMENT. SHOULD FURTHER INFORMATION BE PROVIDED THAT WOULD CHANGE THIS CONCLUSION, AN UPDATE TO THIS REPORT WILL BE PROVIDED WITHIN 30 DAYS OF RECEIPT OF THE ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    DR. CALLED WITH QUESTIONS RELATED TO A PT WITH CORNEAL ULCER ONLY IN THE LEFT EYE AND LOT NUMBER. THE MEDICAL RECORD SHOWED THAT VISUAL ACUITY WAS NOT AFFECTED. THIS IS BEING FILED AS CORNEAL ULCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVAIRA SHPHERE (ENFILCON A) LPL, SOFT CONTACT LENS, DAILY WEAR LPL COOPERVISION CARRIBBEAN CORP. 508255003123

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other