BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAILIES TOTAL 1

    MDR report key: 12810949 · Received November 15, 2021

    Report

    Report Number
    1065835-2021-00005
    Event Type
    Injury
    Date Received
    November 15, 2021
    Report Date
    February 17, 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
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT SAMPLE HAS NOT RETURNED 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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    H3, H6: THE LOT NUMBER WAS NOT PROVIDED AND THE COMPLAINT SAMPLE WAS NOT MADE AVAILABLE FOR EVALUATION. THE DEVICE HISTORY RECORD REVIEW FOR THE PRODUCT COULD NOT BE PERFORMED AS SPECIFIC PRODUCT IDENTIFIERS WERE NOT PROVIDED. THE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED AS SPECIFIC PRODUCT IDENTIFIERS (LOT NUMBER, BATCH NUMBER, AND/OR SERIAL NUMBER) WERE NOT PROVIDED. ALSO, A SPECIFIC ROOT CAUSE ASSOCIATED WITH THE MANUFACTURING PROCESS WAS NOT IDENTIFIED. THERE HAVE BEEN NO SIGNALS OR ADVERSE TRENDS IDENTIFIED. NO FURTHER ACTION WILL BE TAKEN BY THE MANUFACTURING SITE AS NO SPECIFIC ROOT CAUSE WAS IDENTIFIED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    THIS COMPLAINT IS IN REFERENCE TO THE ALCON PRODUCT DAILIES TOTAL 1. AS INITIALLY REPORTED BY A HEALTHCARE PROFESSIONAL, STATED THAT THE CONSUMER EXPERIENCED FUNGAL INFECTION IN ONE EYE. SYMPTOMS RESOLUTION WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1715636 DAILIES TOTAL 1 LENSES, SOFT CONTACT, DAILY WEAR LPL ALCON RESEARCH, LLC NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other