BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEARSCIENCE LIPIFLOW THERMAL PULSATION SYSTEM

    MDR report key: 13343292 · Received January 24, 2022

    Report

    Report Number
    MW5106932
    Event Type
    Injury
    Date Received
    January 24, 2022
    Date of Event
    May 20, 2021
    Report Date
    January 20, 2022
    Manufacturer
    JOHNSON & JOHNSON VISION / TEARSCIENCE, INC.
    Product Code
    ORZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    GOT THE LIPIFLOW TREATMENT DONE IN BOTH EYES. THIS WAS DONE USING TEARSCIENCE LIPIFLOW THERMAL PULSATION SYSTEM. RESULTED IN SEVERE INFLAMMATION IN BOTH EYES. NOW, BECAUSE OF THE SEVERE INFLAMMATION AND SUBSEQUENT TREATMENTS INCLUDING MULTIPLE ROUNDS OF STEROIDS, I HAVE DEVELOPED CONJUNCTIVAL CHALASIS IN BOTH EYES. VERY PAINFUL. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702440 TEARSCIENCE LIPIFLOW THERMAL PULSATION SYSTEM EYELID THERMAL PULSATION SYSTEM ORZ JOHNSON & JOHNSON VISION / TEARSCIENCE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male Required Intervention| O OMEGA-3 SUPPLEMENTS| RESTASIS FOR DRY EYES