BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRESHLOOK ONE-DAY

    MDR report key: 17939202 · Received October 16, 2023

    Report

    Report Number
    9610813-2023-00028
    Event Type
    Injury
    Date Received
    October 16, 2023
    Date of Event
    September 14, 2023
    Report Date
    November 2, 2023
    Manufacturer
    CIBA VISION GMBH
    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 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. THE ROOT CAUSE COULD NOT BE DETERMINED. D.4.: THIS IS THE SECOND 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 2328478 FOR THE REPORTED LOT NUMBER. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    H.3., H.6.: THE COMPLAINT PRODUCT WAS RETURNED FOR EVALUATION AND WAS FOUND TO MEET MANUFACTURING SPECIFICATIONS. THE MANUFACTURING REVIEW DID NOT INDICATE THAT THIS COMPLAINT WAS DUE TO THE MANUFACTURING PROCESS. NO COMPLAINT OR MANUFACTURING TREND WAS IDENTIFIED. THE ROOT CAUSE COULD NOT BE DETERMINED. D.4.: THIS IS THE SECOND OF TWO REPORTS FOR THE SAME PATIENT INVOLVING TWO LOT NUMBERS. IT IS (B)(4) THAT CONTRIBUTED TO THE EVENT REFER TO QS (B)(4) FOR THE REPORTED LOT NUMBER. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    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
    2145015 FRESHLOOK ONE-DAY LENS, CONTACT, (DISPOSABLE) MVN CIBA VISION GMBH NA N0706918

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention DAILIES FRESHLOOK ILLUMINATE