BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAILIES TOTAL 1

    MDR report key: 14470197 · Received May 23, 2022

    Report

    Report Number
    1065835-2022-00003
    Event Type
    Injury
    Date Received
    May 23, 2022
    Report Date
    June 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
    TX, 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

    H.3., H.6.: 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. ALL DEVICE HISTORY RECORDS ARE REVIEWED PRIOR TO PRODUCT RELEASE TO ENSURE THE PRODUCT WAS MANUFACTURED IN COMPLIANCE WITH THE DEVICE MASTER RECORD AND MEETS RELEASE CRITERIA. PER THE STERILIZATION EFFECTIVENESS MEMO, DUE TO THE STERILIZATION CYCLE USED TO PRODUCE THESE CONTACT LENSES, IT CAN BE CONCLUDED THAT ANY INFECTION OF THE EYE SUFFERED BY PATIENTS USING LENSES THAT HAVE BEEN TERMINALLY STERILIZED AND ARE TAKEN FROM AN INTACT PRIMARY PACKAGE CANNOT BE THE RESULT OF ANY ORGANISM ORIGINATING FROM THAT PACKAGE. NO COMPLAINT OR MANUFACTURING TREND WAS IDENTIFIED. THE ROOT CAUSE COULD NOT BE DETERMINED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED FIVE INSTANCES WHERE CONSUMERS HAVE EXPERIENCED BACTERIAL/MICROBIAL KERATITIS IN FORM OR OF CORNEAL ULCERS. ALSO REPORTED ONE INSTANCE WHERE CONSUMER SLEPT WITH CONTACT LENSES. THE CURRENT STATUS OF THE CONSUMER'S EYE IS NOT KNOWN 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
    1200930 DAILIES TOTAL 1 LENSES, SOFT CONTACT, DAILY WEAR LPL ALCON RESEARCH, LLC NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other