BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-VUE

    MDR report key: 839963 · Received April 12, 2007

    Report

    Report Number
    1034196-2007-00001
    Event Type
    Injury
    Date Received
    April 12, 2007
    Date of Event
    March 24, 2007
    Report Date
    April 12, 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

    EVAL OF THE RETURNED PORTION OF THE LENS WAS INCONCLUSIVE. THE NATURE OF THE FRACTURE AS SEEN UNDER VISIBLE AND POLARIZED LIGHT WAS OF A PROPAGATED FRACTURE ACROSS THE OPTIC, WITH NO APPARENT STRESS FRACTURES INDICATING A POINT OF IMPACT OR DAMAGE. NO CONCLUSIONS CAN BE DRAWN CONCERNING THE DAMAGE THAT OCCURRED TO THE LENS TO CAUSE IT TO BREAK INTO PIECES.

    Description of Event or Problem · 1

    ON 26 MAR 2007, NOTIFIED BY SALES REP THAT EYE CLINIC HAD A PT REPORT A CVUE GP CONTACT LENS BROKE IN THE EYE, AND WAS TREATED AT THE ER. WHEN CONTACTED LATER IN THE DAY, THE CONTACT LENS ASSOCIATE REVIEWED THE ER REPORT: ON SATURDAY MORNING, THE PT NOTED HIS RIGHT EYE BEGAN TO HURT, AND COULD NOT REMOVE HIS CONTACT. HE PRESENTED AT THE ER AND WAS SEE BY AN ATTENDING PHYSICIAN. ONLY ONE PORTION OF THE LENS REMAINED IN THE EYE, AND AFTER SEARCHING AND FLUSHING THE EYE, THE REMAINING PORTION WAS RETRIEVED. THE PT WAS DIAGNOSED WITH A CORNEAL ABRASION, WAS PROVIDED WITH VIGAMOX ANTIBIOTIC FOR APPLICATION 3X DAILY, INSTRUCTED TO LEAVE HIS LENSES OUT AND TO SEE HIS EYECARE PRACTITIONER ON MONDAY. THE PT'S VISUAL ACUITY WITH SPECTACLE CORRECTION WAS 20/60 IN THE RIGHT EYE AT THE CONCLUSION OF THE ER VISIT. THREE DAYS LATER,ADVISED BY A PHONE MAIL THAT THE PT HAD SEEN THE EYECARE PRACTITIONER AND THE EYE WAS FOUND IN EXCELLENT CONDITION WITH NO RESIDUAL EFFECT.

    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 907107

    Patients

    Seq Age Sex Outcome Treatment
    1 *