BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENFILCON A / AVAIRA SPHERE

    MDR report key: 3771375 · Received April 24, 2014

    Report

    Report Number
    2640128-2014-00002
    Event Type
    Injury
    Date Received
    April 24, 2014
    Report Date
    March 31, 2014
    Manufacturer
    COOPERVISION CARIBBEAN CORPORATION
    Product Code
    LPL
    PMA / PMN Number
    K071736
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LENSES WERE NOT RETURNED. LOT NUMBERS ARE UNKNOWN. NO DEVICE INVESTIGATION COULD BE PERFORMED. THE COMPLAINT IS UNCONFIRMED.

    Description of Event or Problem · 1

    COOPERVISION RECEIVED A COMPLAINT BY EMAIL IN WHICH THE CUSTOMER ALLEGES HAVING SUSTAINED RECURRENT CORNEAL EROSIONS WITH THE AVAIRA LENS. FURTHER DETAILS RELATE THAT THE CUSTOMER SWITCHED TO A DIFFERENT BRAND OF CONTACT LENSES AND AFTER 3 MONTHS OF USE, RETURNED TO AVAIRA LENSES WHEN THE RECURRENT CORNEAL EROSION OCCURED. THE DATE OF EVENT IS UNKNOWN. NO OTHER MEDICAL INFORMATION WAS ABLE TO BE OBTAINED UP TO THE DATE OF THIS REPORT. LENSES WERE NOT RETURNED. LOT NUMBERS ARE UNKNOWN. NO DEVICE INVESTIGATION COULD BE PERFORMED. THE COMPLAINT IS UNCONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249472 ENFILCON A / AVAIRA SPHERE ENFILCON A / AVAIRA SPHERE LPL COOPERVISION CARIBBEAN CORPORATION UKN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other