BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAILIES TOTAL 1

    MDR report key: 14826813 · Received June 27, 2022

    Report

    Report Number
    1065835-2022-00004
    Event Type
    Injury
    Date Received
    June 27, 2022
    Report Date
    June 27, 2022
    Manufacturer
    ALCON RESEARCH, LLC
    Product Code
    LPL
    PMA / PMN Number
    K113168
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATED BY MFR: THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD AND INVESTIGATION INCLUDED A REVIEW OF THE LOT COMPLAINT HISTORY, COMPLAINT TREND, MANUFACTURING HISTORY, NON-CONFORMANCE HISTORY, IN-PROCESS SAMPLING/CONTROL DATA, EQUIPMENT/CALIBRATION, FILLING/PACKAGING, TRAINING RECORDS, 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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    THE CONSUMER REPORTED THAT WHILE WEARING LENSES EXPERIENCED A CORNEAL ULCER. THE CURRENT STATUS OF THE CONSUMER'S EYE IS UNKNOWN AT THE TIME OF THIS REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889830 DAILIES TOTAL 1 LENSES, SOFT CONTACT, DAILY WEAR LPL ALCON RESEARCH, LLC NA A5116672

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other