BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRESHLOOK COLORBLENDS UV

    MDR report key: 1910308 · Received November 18, 2010

    Report

    Report Number
    1422160-2010-00006
    Event Type
    Injury
    Date Received
    November 18, 2010
    Date of Event
    October 11, 2010
    Report Date
    October 25, 2010
    Manufacturer
    CIBA VISION CORP
    Product Code
    LPM
    PMA / PMN Number
    P830037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A FOLLOW-UP MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT SHE INSERTED NEW FRESHLOOK COLORBLENDS UV CONTACT LENSES IN HER EYES ON (B)(6) 2010. THE LEFT LENS WAS IRRITATING, THE EYE BECAME RED, AND THE IRRITATION DID NOT RESOLVE. TEN DAYS LATER, SHE VISITED HER EYECARE PROFESSIONAL. SHE DID NOT WEAR LENSES BETWEEN REMOVAL ON (B)(6) 2010 AND THE EYECARE VISIT ON (B)(6) 2010. THE PATIENT REPORTED BEING DIAGNOSED WITH AN INFECTION AND WAS PRESCRIBED GATIFLOXACIN ANTIBIOTIC DROPS EVERY HOUR AND FLUOROMETHOLONE STEROID DROPS TWICE A DAY. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2010 FROM THE PATIENT INDICATED THAT SHE WAS BLIND IN ONE EYE AND LOST 60% OF HER SIGHT. THE CONDITION WAS NOT IMPROVING AND SHE WAS TAKING ADDITIONAL MEDICATIONS. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2010 FROM THE EYECARE PROFESSIONAL CONFIRMED THE LEFT EYE WAS INFLAMED, NO ULCER PRESENT, AND THE PATIENT WAS EXPERIENCING DECREASED VISION, ALTHOUGH SHE WAS NOT WEARING ANY VISION CORRECTION. THE PATIENT WAS DIAGNOSED WITH DIFFUSED KERATITIS. SHE STARTED TREATMENT WITH ZYMMAR FOR INFLAMMATION AND THEN IT WAS DISCONTINUED TO START A STEROID FOR 1 WEEK. THE PATIENT IS IMPROVING SLOWLY AND THE EYECARE PROFESSIONAL DOES NOT ANTICIPATE ANY PERMANENT VISION LOSS. THE EYECARE PROFESSIONAL INDICATED THE PATIENT'S HYGIENE IS VERY POOR AND SHE WEARS THE LENSES AS EXTENDED WEAR. ACCORDING TO THE EYECARE PROFESSIONAL, THE PATIENT IS NON-COMPLIANT AND IT IS UNKNOWN HOW OFTEN THE PATIENT REMOVES THE CONTACT LENSES FROM HER EYES. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2010 FROM THE PATIENT INDICATED THE EYE IS NO LONGER SWOLLEN, BUT STILL RED AND HAVING VISION ISSUES WITH THE LEFT EYE, HOWEVER, NO VISION CORRECTION IS BEING USED. SHE CONTINUES TO USE THE PRESCRIBED MEDICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRESHLOOK COLORBLENDS UV SOFT CONTACT LENS LPM CIBA VISION CORP 306583

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention