BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAIRA SPHERE ENFILCON A

    MDR report key: 2884020 · Received December 21, 2012

    Report

    Report Number
    9614392-2012-00101
    Event Type
    Injury
    Date Received
    December 21, 2012
    Report Date
    November 23, 2012
    Manufacturer
    COOPERVISION MANUFACTURING LIMITED
    Product Code
    LPL
    PMA / PMN Number
    K071736
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    NO LENSES RETURNED AND NO LOT INFORMATIN PROVIDED.

    Description of Event or Problem · 1

    COOPERVISION, INC. RECEIVED A LETTER FROM A LAW OFFICE STATING THE PATIENT SUSTAINED A PERMANENT EYE INJURY RELATED TO THE LENS. FOLLOW UP ATTEMPTS HAVE BEEN MADE TO CONTACT THE LAW OFFICE FOR MORE INFORMATION WITH NO REPLY TO DATE. THIS IS BEING FILED AS UNCONFIRMED PERMEANT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability