BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAILIES AQUACOMFORT PLUS CONTACT LENSES

    MDR report key: 20312145 · Received September 25, 2024

    Report

    Report Number
    MW5160132
    Event Type
    Malfunction
    Date Received
    September 25, 2024
    Date of Event
    September 10, 2024
    Report Date
    September 23, 2024
    Manufacturer
    ALCON RESEARCH, LLC
    Product Code
    LPL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT WOKE UP THE MORNING OF (B)(6) WITH A RED, SORE, LIGHT SENSITIVE LEFT EYE. NOTICED A WHITE SPOT ON IT. SHE WAS DOING LAWN WORK THE PREVIOUS DAY. HAD HER CONTACTS IN AND EYE PROTECTION ON. SHE USES DAILIES AQUACOMFORT PLUS CONTACT LENSES MANUFACTURED BY ALCON. SHE DID NOT SLEEP IN HER LENSES. SHE DISPOSES OF HER CONTACTS DAILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1061030 DAILIES AQUACOMFORT PLUS CONTACT LENSES LENSES, SOFT CONTACT, DAILY WEAR LPL ALCON RESEARCH, LLC A0736618

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown