BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAIRA (ENFILCON A)

    MDR report key: 2041189 · Received March 29, 2011

    Report

    Report Number
    9614392-2011-00012
    Event Type
    Injury
    Date Received
    March 29, 2011
    Report Date
    March 2, 2011
    Manufacturer
    COOPERVISION MANUFACTURING LIMITED
    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 THE SECOND OF TWO REPORTS ON THE SAME EVENT INVOLVING TWO LENSES, ONE IS A -2.25 AND THE OTHER IS A -1.50. REFER TO MEDWATCH 9614392-2011-00009 FOR A DESCRIPTION OF THE FIRST REPORT. EVENT WAS REC'D DIRECTLY FROM THE PT'S MOTHER VIA E-MAIL TO COOPERVISION'S CUSTOMER SERVICE DEPARTMENT. PT REPORTED AN EYE INFECTION IN BOTH EYES. METHOD: NO LOT INFORMATION, NO LENSES, NO DEVICE INFORMATION, 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 THE PT COMPLAINS OF. CONCLUSION: NO CONCLUSION CAN BE DRAWN. THIS IS BEING REPORTED AS A POSSIBLE EYE INFECTION IN BOTH EYES WITH NO DIRECT CAUSAL RELATIONSHIP ESTABLISHED BETWEEN THE MEDICAL DEVICE AND THE INCIDENT. SHOULD FURTHER INFORMATION BE PROVIDED THAT WOULD CHANGE THIS CONCLUSION, AN UPDATE TO THIS REPORT WILL BE PROVIDED WITHIN ONE MONTH OF RECEIPT OF THE ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    PT WAS PRESCRIBED AVAIRA (ENFILCON A) CONTACT LENSES. THE PT'S RX IS -2.25 AND -1.50. PT DEVELOPED OCULAR INFECTIONS IN BOTH EYES. THE PT WAS "BANNED" FROM WEARING LENSES FOR A MONTH. THE PT DOES NOT WEAR LENSES EVERYDAY AND WHEN SHE DOES, IT IS ONLY FOR A MATTER OF HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVAIRA (ENFILCON A) LPL, SOFT CONTACT LENS, DAILY WEAR LPL COOPERVISION MANUFACTURING LIMITED UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other