BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAILIES FRESHLOOK ILLUMINATE

    MDR report key: 3409219 · Received October 9, 2013

    Report

    Report Number
    9610813-2013-00019
    Event Type
    Injury
    Date Received
    October 9, 2013
    Date of Event
    August 27, 2013
    Report Date
    September 6, 2013
    Manufacturer
    CIBA VISION GMBH
    Product Code
    MVN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO INITIAL REPORTER INFO WAS PROVIDED DUE TO PRIVACY. (B)(4). PMA/510(K): 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 ON-DAY THAT IS SOLD IN THE UNITED STATES UNDER PMA/S1O (K) # K050213. THE DEVICE HISTORY RECORD AND STERILIZATION RECORD FOR THIS LOT HAVE BEEN REVIEWED AND FOUND TO BE IN COMPLIANCE. OPENED PRODUCT FROM THE SAME LOT WAS RETURNED AND FOUND TO BE OUT OF SPECIFICATION DUE TO BEING TORN. RETAINED PRODUCT FROM THE SAME LOT WAS EVALUATED AND ALL TESTING WAS FOUND TO BE WITHIN SPECIFICATION. THERE WAS NO NONCONFORMITY 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 EYE CARE PROFESSIONAL (ECP) THAT ON (B)(6) 2013, THE PT FELT DISCOMFORT RIGHT AFTER INSERTING THE LENS, BUT CONTINUED WEARING THE LENS FOR SEVERAL HOURS. THE PT REMOVED THE LENS AND NOTED THAT IT WAS TORN. ON THE FOLLOWING DAY, THE PT EXPERIENCED PAIN, EYE MUCUS AND WAS UNABLE TO TEAR THE CONTACT LENS. THE PT VISITED THE ECP ON (B)(6) 2013 AND WAS DIAGNOSED WITH BACTERIAL KERATITIS IN THE RIGHT EYE. THE PT HAD A FOLLOW UP WITH THE ECP ON (B)(6) 2013 AND AT THAT TIME, THE SYMPTOMS HAD NOT YET RESOLVED. AS OF (B)(6) 2013, THE PT HAS NOT RETURNED TO THE ECP FOR FOLLOW UP AND THEY BARE NOT SURE IF THE PT WILL BE RETURNING. ADDITIONAL INFO WAS RECEIVED ON (B)(6) 2013, FROM THE ECP STATING THAT ON (B)(6) 2013, THE PT WAS PRESCRIBED FLUOROMETHOLONE (ANTI-INFLAMMATORY) AND LEVOFLOXACIN (ANTIBIOTIC). THERE WAS A "NON-SERIOUS INFILTRATION" AT 6 O' CLOCK (PERIPHERAL) ON THE CORNEA. IT IS NOTED THAT THERE IS NO FURTHER INFO, AND THE DOCTOR WILL BE IN CONTACT IF THE PT VISITS AGAIN. ADDITIONAL INFO WAS RECEIVED FROM THE ECP ON (B)(6) 2013, STATING THAT THE INFILTRATION IS GETTING BETTER AND NO MORE EYE DROPS HAVE BEEN PRESCRIBED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513167 DAILIES FRESHLOOK ILLUMINATE LENS, CONTACT (DISPOSABLE) MVN CIBA VISION GMBH N0601673

    Patients

    Seq Age Sex Outcome Treatment
    1 Other