BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIPIFLOW

    MDR report key: 7689338 · Received July 13, 2018

    Report

    Report Number
    MW5078403
    Event Type
    Injury
    Date Received
    July 13, 2018
    Date of Event
    August 8, 2017
    Report Date
    July 9, 2018
    Manufacturer
    TEARSCIENCE, INC.
    Product Code
    ORZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MY DOCTOR RECOMMENDED THAT I PURSUE THE LIPIFLOW PROCEDURE TO REMOVE THE BLOCKAGE IN THE MEIBOMIAN GLANDS IN THE EYELIDS THAT PRODUCE THE PROTECTIVE OILY LAYER OF THE TEAR FILM. BEFORE I AGREED TO THIS MEDICAL DEVICE PROCEDURE, A COMPANY REPRESENTATIVE TOOK A PHOTO OF MY GLANDS THAT CLEARLY SHOWED SOME BLOCKAGE. BEFORE I ELECTED TO HAVE THE LIPIFLOW PROCEDURE THE DOCTOR SUGGESTED I TRY OTC LUBRICANT EYE DROPS. THESE EYE DROPS WERE NOT EFFECTIVE IN REDUCING THE DRY EYE CONDITION THAT IS NORMALLY PRODUCED BY THE MEIBOMIAN GLANDS. THE LIPIFLOW PROCEDURE INVOLVES THE USE OF A MEDICAL DEVICE PLACED OVER EACH EYE AND PERFORMS AN APPLICATION REFERRED TO ¿VECTORED THERMAL PULSATION¿. THE ENTIRE PROCEDURE TOOK LESS THAN 10 MINUTES. I WAS TOLD BY THE DOCTOR¿S TECHNICIAN THAT SUCCESS WOULD TAKE SEVERAL WEEKS TO REFLECT ANY NOTICEABLE IMPROVEMENT IN MY DRY EYE CONDITION. AS THE WEEKS AND MONTHS PASSED, I KEPT IN CONTACT WITH DOCTOR AND HE DID NOT UNDERSTAND WHY I DID NOT RECEIVE ANY RELIEF. THE PROCEDURE COST (B)(6) AND INSURANCE DID NOT COVER ANY PORTION OF THE COST. I CANNOT FIND ANY SPECIFIC NAME FOR THE DEVICE USED TO CONDUCT THE LIPIFLOW APPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530301 LIPIFLOW LIPIFLOW ORZ TEARSCIENCE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Disability