BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMAFILCON 60 ASPHERE (OMAFILCON A)

    MDR report key: 2620793 · Received June 8, 2012

    Report

    Report Number
    2640128-2012-00016
    Event Type
    Injury
    Date Received
    June 8, 2012
    Report Date
    May 14, 2012
    Manufacturer
    COOPERVISION CARIBBEAN CORP.
    Product Code
    MVN
    PMA / PMN Number
    K061948
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS BEING FILED AS UNCONFIRMED CORNEAL STAINING. THE DEVICE COULD NOT BE EVALUATED AS THE CUSTOMER HAS THROWN IT AWAY. NO LOT INFORMATION WAS PROVIDED, THEREFORE, NO EVALUATION OR CONCLUSIONS CAN BE DRAWN. 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

    ON (B)(6) 2012, THE MEDICAL PRODUCTS AGENCY (MPA) OF (B)(4) NOTIFIED COOPERVISION, INC. OF AN INCIDENT MPA (B)(4). THE PT HAS SERIOUS CORNEAL STAINING AND WAS RECOMMENDED LENS REST UNTIL HEALED. THE EXTENT OF THE CORNEAL STAINING IS UNK. NO LENSES WERE RETURNED. NO LOT INFORMATION PROVIDED. ATTEMPTS TO CONTACT THE MPA FOR MORE INFORMATION HAVE BEEN MADE WITH NO REPLY TO DATE. THIS IS BEING FILED AS UNCONFIRMED CORNEAL STAINING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMAFILCON 60 ASPHERE (OMAFILCON A) LPL, SOFT CONTACT LENS, DAILY WEAR MVN COOPERVISION CARIBBEAN CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other