BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAILIES FRESHLOOK ILLUMINATE

    MDR report key: 3781029 · Received April 16, 2014

    Report

    Report Number
    9610813-2014-00006
    Event Type
    Injury
    Date Received
    April 16, 2014
    Date of Event
    November 29, 2013
    Report Date
    November 29, 2013
    Manufacturer
    CIBA VISION GMBH
    Product Code
    MVN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD AND STERILIZATION RECORD FOR THIS LOT HAVE BEEN REVIEWED AND FOUND TO BE IN COMPLIANCE. UNOPENED PRODUCT FROM THE SAME LOT WAS RETURNED AND FOUND TO BE WITHIN SPECIFICATION. RETAINED PRODUCT FROM THE SAME LOT WAS ALSO EVALUATED AND ALL TESTING WAS FOUND TO BE WITHIN SPECIFICATION. THERE WERE NO NON-CONFORMITIES OR DEVIATIONS DURING THE MANUFACTURING PROCESS WHICH RELATED TO THE NATURE OF THE COMPLAINT. THE ROOT CAUSE COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT AFTER FEELING PAIN WHEN WEARING THE LENS, THE PATIENT REMOVED THE LENS AND FOUND IT WAS TORN. IT IS NOTED THAT THE EYE RECOVERED. ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT ON (B)(6) 2014 STATING THAT AT THE TIME OF THE INITIAL COMPLAINT, THE PATIENT STATED THAT THE SYMPTOMS HAD RESOLVED, HOWEVER, LATER THAT DAY THE PATIENT STARTED TO FEEL PAIN. TWO DAYS LATER THE PATIENT VISITED THE DOCTOR WHO STATED THAT THE PATIENT HAD A SCRATCH WHICH WAS INFECTED. "THERE WAS A WHITE ROUND BLOTCH ON THE BLACK EYE PART". THE PATIENT DID NOT KNOW WHAT THE DIAGNOSIS WAS. THE EVENT TOOK ONE MONTH TO RESOLVE AND THE PATIENT VISITED THE DOCTOR 6 TO 7 TIMES DURING THAT PERIOD OF TIME. PATIENT WAS PRESCRIBED UNSPECIFIED EYE DROPS (MOISTURE AGENT, ANTIBIOTIC AND ANTI-INFLAMMATORY STEROID) AS WELL AS UNSPECIFIED ANTIBIOTIC EYE OINTMENT. THE PATIENT WAS INSTRUCTED TO STOP WEARING LENSES UNTIL THE SYMPTOMS HAD RESOLVED. AT THIS TIME, THE SYMPTOMS HAVE RESOLVED. ADDITIONAL INFORMATION WAS REQUESTED, BUT THE PATIENT REFUSED TO RELEASE ANY ADDITIONAL INFORMATION. THIS PRODUCT IS NOT APPROVED OR INTRODUCED INTO COMMERCIAL DISTRIBUTION IN THE UNITED STATES. HOWEVER, THIS MEDWATCH IS BEING FILED BASED ON A SIMILAR PRODUCT FRESHLOOK ONE-DAY THAT IS SOLD IN THE UNITED STATES UNDER PMA/510 (K) # K050213.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234064 DAILIES FRESHLOOK ILLUMINATE LENS, CONTACT (DISPOSABLE) MVN CIBA VISION GMBH N0218818

    Patients

    Seq Age Sex Outcome Treatment
    1 Other