BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAILIES FRESHLOOK ILLUMINATE

    MDR report key: 6093035 · Received November 10, 2016

    Report

    Report Number
    9610813-2016-00022
    Event Type
    Injury
    Date Received
    November 10, 2016
    Date of Event
    October 6, 2016
    Report Date
    November 23, 2016
    Manufacturer
    CIBA VISION GMBH
    Product Code
    MVN
    PMA / PMN Number
    K050213
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT APPROVED OR INTRODUCED INTO COMMERCIAL DISTRIBUTION IN THE UNITED STATES. HOWEVER, THIS MEDWATCH FORM 3500A IS BEING FILED BASED ON A SIMILAR PRODUCT (FRESHLOOK ONE-DAY) THAT IS SOLD IN THE UNITED STATES UNDER PMA/510(K) # K050213. THE COMPLAINT SAMPLE IS NOT AVAILABLE FOR EVALUATION; THE LOT NUMBER IS UNKNOWN. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS NOT PROVIDED AND THE COMPLAINT SAMPLE WAS NOT MADE AVAILABLE FOR EVALUATION. THE MANUFACTURING REVIEW DID NOT INDICATE THAT THIS COMPLAINT WAS DUE TO THE MANUFACTURING PROCESS, AS NO COMPLAINT OR MANUFACTURING TREND WAS IDENTIFIED. THE ROOT CAUSE COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    AS INITIALLY REPORTED VIA FAX FROM THE PMDA: AN EYE CARE PROFESSIONAL (ECP) REPORTED THAT A PATIENT EXPERIENCED ACHE AND RED EYE ON (B)(6) 2016, CAUSING HER TO CONSULT A PHYSICIAN ON (B)(6) 2016. THE PATIENT WAS DIAGNOSED WITH A CORNEAL ULCER, CORNEAL INFILTRATION, AND IRITIS IN THE RIGHT EYE. THE PATIENT WAS PRESCRIBED LEVOFLOXACIN EYE DROPS TO USE SIX TIMES PER DAY, AS WELL AS PHENYLEPHRINE/TROPICAMIDE EYE DROPS TO USE ONCE A DAY. IT WAS ALSO REPORTED THAT THE PATIENT UNDERWENT CORNEAL SCRAPING. THE PATIENT WAS INSTRUCTED TO SUSPEND CONTACT LENS WEAR FOR AN UNSPECIFIED AMOUNT OF TIME. ADDITIONAL INFORMATION RECEIVED ON 10/21/2016 CLARIFIED THAT THE CORNEAL ULCER WAS LOCATED DOWNWARDS, IN THE FIVE OCLOCK POSITION, AND WAS 0.3  0.5 MM IN SIZE; CILIARY HYPEREMIA WAS NOT SEVERE. THE DEGREE OF ANTERIOR CHAMBER INVOLVEMENT COULD NOT BE CONFIRMED. THE PATIENT FOLLOWED UP WITH THE ECP ON (B)(6) 2016, WITH EYE RECOVERY CONFIRMED ON (B)(6) 2016. THE ECP INSTRUCTED THE PATIENT TO SUSPEND COLORED CONTACT LENS WEAR. THE EVENT HAS RESOLVED AND CONTACT LENS WEAR HAS RESUMED WITH NON-COLORED CONTACT LENSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745831 DAILIES FRESHLOOK ILLUMINATE NA MVN CIBA VISION GMBH NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention