BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAILIES FRESHLOOK ILLUMINATE

    MDR report key: 4059108 · Received August 8, 2014

    Report

    Report Number
    9610813-2014-00017
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    July 15, 2014
    Report Date
    July 19, 2014
    Manufacturer
    CIBA VISION GMBH
    Product Code
    LPL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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. UNOPENED PRODUCT FROM THE SAME LOT NUMBER WAS RETURNED FOR EVALUATION AND FOUND TO MEET SPECIFICATIONS. THE INVESTIGATION IS IN PROGRESS. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    THIS IS THE SECOND OF TWO REPORTS FOR THE SAME PT INVOLVING TWO LOT NUMBERS OF THE SAME PRODUCT FOR A BILATERAL EVENT. REFER TO 9610813-2014-00016 FOR THE DESCRIPTION OF THE SECOND REPORT. IT WAS REPORTED BY A CONTACT LENS SHOP THAT A CONSUMER FOUND A SCRATCH ON THE CONTACT LENSES AND INSERTED THEM. WHEN THE CONSUMER WORE THE PRODUCT PAIN WAS EXPERIENCED AND THE CONSUMER WAS ADVISED BY A DOCTOR THAT THERE WERE SCRATCHES ON THE CORNEAS. FOLLOW UP INFO PROVIDED BY THE CONSUMER STATED THAT THE CONSUMER EXPERIENCED RED EYE WHILE WEARING THE LENSES AND THE NEXT DAY, THE CONSUMER EXPERIENCED RED EYE AGAIN AS WELL AS LACRIMATION AND PHOTOPHOBIA. THE CONSUMER VISITED THE DOCTOR AND WAS ADVISED THAT THERE WERE MULTIPLE SCRATCHES ON THE EYES. THE CONSUMER REPORTS THAT THE EVENT OCCURRED SIMULTANEOUSLY IN BOTH EYES. THE CONSUMER WAS PRESCRIBED AN UNSPECIFIED ANTIBIOTIC, MOISTURIZING AGENT, AND AN ORAL ANTI-INFLAMMATORY ANALGESIC. NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473071 DAILIES FRESHLOOK ILLUMINATE LENS, CONTACT (DISPOSABLE) LPL CIBA VISION GMBH N0226030

    Patients

    Seq Age Sex Outcome Treatment
    1 Other