BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C-VUE

    MDR report key: 880626 · Received July 13, 2007

    Report

    Report Number
    1034196-2007-00002
    Event Type
    Malfunction
    Date Received
    July 13, 2007
    Date of Event
    June 13, 2007
    Report Date
    July 13, 2007
    Manufacturer
    UNILENS CORP., USA
    Product Code
    HPX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - MFG RECORDS WERE EXAMINED.

    Description of Event or Problem · 1

    ON 13 JUNE 2007, NOTIFIED BY SALES REP THAT SAPULA VISION, SAPULA OK, HAD A PATIENT REPORT A CVUE GP CONTACT LENS BROKE IN THE EYE, AND WAS TREATED AT THE EMERGENCY ROOM. THE PHYSICIAN WAS CONTACTED 14 JUNE AND HAD NO FURTHER INFORMATION, AS HE HAD NOT SEEN THE PATIENT. NO FURTHER INFORMATION HAS BEEN PROVIDED AFTER REPEATED CONTACT WITH THE EYECARE PRACTITIONER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-VUE RIGID GAS PERMEABLE CONTACT LENS HPX UNILENS CORP., USA CVUE GP 909705

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention