BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAILIES AQUACOMFORT PLUS

    MDR report key: 14133306 · Received April 18, 2022

    Report

    Report Number
    1065835-2022-00002
    Event Type
    Injury
    Date Received
    April 18, 2022
    Report Date
    May 30, 2022
    Manufacturer
    ALCON RESEARCH, LLC
    Product Code
    LPL
    PMA / PMN Number
    K072777
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    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).

    Additional Manufacturer Narrative · 0

    H.3., H.6.: THE COMPLAINT PRODUCT WAS RETURNED FOR EVALUATION AND WAS FOUND TO MEET MANUFACTURING SPECIFICATIONS. ALL SAMPLES WERE VISUALLY INSPECTED AND ACCEPTABLE FOR EVALUATION. TWO SEALED LENSES WERE SELECTED FOR FURTHER INSPECTION. BOTH SAMPLES WERE FOUND TO MEET MANUFACTURING SPECIFICATIONS FOR PACKAGE INTEGRITY, PH, OSMOLALITY, SURFACE, EDGE, BASE CURVE, AND DIAMETER. THE DEVICE HISTORY RECORD REVIEW OF THE LOT NUMBER PROVIDED INDICATED THE PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE PRODUCT¿S ACCEPTABLE CRITERIA. A FAILURE OF THE DEVICE, LABELING, OR PACKAGING TO MEET SPECIFICATIONS COULD NOT BE CONFIRMED. AS SUCH, NO CLEAR RELATIONSHIP CAN BE ESTABLISHED BETWEEN THE DEVICE AND THE REPORTED INCIDENT OR ADVERSE EVENT. 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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: 2022-17035

    Description of Event or Problem · 0

    A CONSUMER REPORTED THAT CONTACTS WERE TORN, AND THEY ARE NOT HOLDING UP. CONTACT ALSO TORN IN LEFT EYE. THE CONSUMER EXPERIENCED EYE INFECTION AND USED EYE DROPS FOR IT ALSO EXPERIENCED SCRATCHED CORNEA. 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
    2414619 DAILIES AQUACOMFORT PLUS LENSES, SOFT CONTACT, DAILY WEAR LPL ALCON RESEARCH, LLC NA A0653332

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other