BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCLEAR TORIC XR (OMAFILCON A)

    MDR report key: 2668999 · Received June 29, 2012

    Report

    Report Number
    1314956-2012-00007
    Event Type
    Injury
    Date Received
    June 29, 2012
    Report Date
    June 29, 2012
    Manufacturer
    COOPERVISION, INC.
    Product Code
    LPL
    PMA / PMN Number
    K952152
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS BEING REPORTED AS UNCONFIRMED CORNEAL DAMAGE.

    Description of Event or Problem · 1

    PT'S MOTHER CALLED IN TO STATE HER SONS CORNEA WAS DAMAGED DUE TO CONTACT LENS WEAR AND MAY NEED A CORNEAL TRANSPLANT. MEDWATCH (B)(4) RECEIVED (B)(4) 2012, NOTES THE PT BEGAN WITH BLURRED VISION AND WAS REFERRED TO SPECIALIST. THE SPECIALIST PRESCRIBED HIM EYE DROPS AND REFERRED PT TO ANOTHER SPECIALIST. THAT SPECIALIST SAID THAT VISION WAS VERY POOR AND CORNEA WAS DAMAGED AND THAT A POSSIBLE CORNEAL TRANSPLANT WAS NEEDED. SEVERAL ATTEMPTS TO CONTACT THE REPORTER FOR MORE INFORMATION HAVE BEEN MADE WITH NO REPLY TO DATE. INCORRECT LOT INFORMATION PROVIDED. NO EYE CARE PROFESSIONAL INFORMATION PROVIDED. THIS IS BEING FILED AS UNCONFIRMED CORNEAL DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROCLEAR TORIC XR (OMAFILCON A) LPL, SOFT CONTACT LENS, DAILY WEAR LPL COOPERVISION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other