BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAILIES TOTAL 1

    MDR report key: 12868135 · Received November 24, 2021

    Report

    Report Number
    1065835-2021-00006
    Event Type
    Injury
    Date Received
    November 24, 2021
    Date of Event
    October 15, 2021
    Report Date
    June 6, 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
    AZ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION UPDATED IN A2, B3, B5 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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED WHICH STATES THAT AN ULCER OCCURRED ON THE RIGHT MEDIAL CORNEA. CONSUMER WAS TREATED WITH NEOMYCIN, POLYMYXIN B SULFATES AND DEXAMETHASONE OPHTHALMIC SUSPENSION FROM (B)(6) 2021 TO (B)(6) 2021.THE CURRENT STATUS OF THE CONSUMER EYE WAS RECOVERED. THIS REPORT OF CENTRALLY LOCATED CORNEAL ULCER, WHICH REQUIRES ADMINISTRATION OF ANTIBIOTIC EYE DROPS, A SERIOUS EVENT, CANNOT BE RULED OUT AT THIS TIME OF REPORT.

    Description of Event or Problem · 0

    A CONSUMER REPORTED, ¿EXPERIENCED SEVERAL LENSES WITH A SHARP EDGE, AND DEVELOPED A CORNEAL ULCER¿ AFTER CONTACT LENS WEAR IN THE RIGHT EYE. THE CONSUMER WAS TREATED WITH ANTIBIOTIC EYE DROPS AND THE SYMPTOMS RESOLVED. THE CONSUMER RESUMED CONTACT LENS WEAR IN THE RIGHT, AND EXPERIENCED ¿A SHARP FEELING LENS¿ IN THE RIGHT EYE AND REMOVED THE LENS. ADDITIONAL INFORMATION WAS REQUESTED FOR THIS EVENT; HOWEVER, NO UPDATES HAVE BEEN RECEIVED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1768175 DAILIES TOTAL 1 LENSES, SOFT CONTACT, DAILY WEAR LPL ALCON RESEARCH, LLC NA A5109202

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female Required Intervention