BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAILIES COMFORT PLUS

    MDR report key: 11760757 · Received April 30, 2021

    Report

    Report Number
    MW5101130
    Event Type
    Injury
    Date Received
    April 30, 2021
    Date of Event
    April 28, 2021
    Report Date
    April 30, 2021
    Manufacturer
    ALCON RESEARCH, LLC
    Product Code
    LPL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CALLER STATED THAT HIS LEFT CONTACT LENS GOT STUCK TO HIS EYES WHEN HE TRIED REMOVING IT. WHILE HE WAS REMOVING THE LENS, IT BROKE AND WAS ONLY ABLE TO REMOVE PARTS OF IT. HE FLUSHED HIS EYES WITH WATER, BUT IT WAS STILL DIFFICULT TO REMOVE, SO HE CONTACTED A MEDICAL PROFESSIONAL WHO ASSISTED IN THE REMOVAL OF THE REMAINDER OF THE BROKEN LENS. CALLER ALSO STATED THAT THE RIGHT CONTACT LENS WAS UNABLE TO BE REMOVED, HE TRIED FLUSHING HIS EYE WITH WATER BUT COULD NOT REMOVE IT. THE MEDICAL PROFESSION ALSO REMOVED THE RIGHT LENS. HE FURTHER STATED THAT HE WEARS HIS CONTACT LENS EVERYDAY AND ON THIS DAY HE ONLY HAS HIS LENS ON FOR LESS THAN FOUR HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647314 DAILIES COMFORT PLUS LENSES, SOFT CONTACT, DAILY WEAR LPL ALCON RESEARCH, LLC LEFT: NO692897
    647315 DAILIES COMFORT PLUS LENSES, SOFT CONTACT, DAILY WEAR LPL ALCON RESEARCH, LLC RIGHT: NO693287

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention