BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAILIES FRESHLOOK ILLUMINATE

    MDR report key: 17939071 · Received October 16, 2023

    Report

    Report Number
    3003657720-2023-00003
    Event Type
    Injury
    Date Received
    October 16, 2023
    Date of Event
    September 14, 2023
    Report Date
    November 10, 2023
    Manufacturer
    CIBA VISION ASIAN MFG AND LOGISTICS PTE LTD.
    Product Code
    MVN
    PMA / PMN Number
    K050213
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H.3., H.6.: THE COMPLAINT SAMPLE HAS NOT RETURNED FOR EVALUATION. 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. D.4.: THIS IS THE FIRST OF TWO REPORTS FOR THE SAME PATIENT INVOLVING TWO LOT NUMBERS OF THE SAME PRODUCT. IT IS UNKNOWN WHICH CONTRIBUTED TO THE EVENT. REFER TO QS 2328479 FOR THE REPORTED LOT NUMBER. "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." THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    H.3., H.6.: THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD AND STERILIZATION RECORD FOR THIS LOT HAVE BEEN REVIEWED AND FOUND TO BE IN COMPLIANCE. THERE WAS NO NONCONFORMITY OR DEVIATIONS DURING THE MANUFACTURING PROCESS WHICH RELATED TO THE NATURE OF THE COMPLAINT. NO COMPLAINT OR MANUFACTURING TREND WAS IDENTIFIED. THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    AS INITIALLY REPORTED BY THE CONSUMER STATING THAT AFTER WEARING CONTACT LENSES IT CAUSED DISCOMFORT; CONSUMER VISITED THE PHYSICIAN AND DIAGNOSED WITH CORNEAL EROSION SYNDROME IN BOTH EYES. PHYSICIAN ADVISED TO STOP WEARING CONTACT LENSES AND PRESCRIBED WITH EYE DROPS. THE CURRENT STATUS OF THE CONSUMER¿S EYES ARE SYMPTOM STILL CONTINUING. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1312935 DAILIES FRESHLOOK ILLUMINATE LENS, CONTACT, (DISPOSABLE) MVN CIBA VISION ASIAN MFG AND LOGISTICS PTE LTD. NA C0404152

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention FRESHLOOK ONE-DAY.