BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HERRICK LACRIMAL PLUG

    MDR report key: 268039 · Received March 8, 2000

    Report

    Report Number
    MW1018359
    Event Type
    Injury
    Date Received
    March 8, 2000
    Date of Event
    March 23, 1998
    Report Date
    March 1, 2000
    Manufacturer
    LACRIMEDICS, INC.
    Product Code
    HMX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EPIPHORA AFTER PLACEMENT OF HERRICK LACRIMAL PLUGS. PT COMPLAINS OF LEFT SIDED EPIPHORA FOR THE LAST 2 YEARS. PT SAYS TEARS RUN DOWN THEIR FACE AND THEY WIPE THEM AWAY ABOUT 3 TIMES EVERY HOUR. THESE INTERFERE WITH DAILY ACTIVITIES SUCH AS READING AND DRIVING. PT ALWAYS CARRIES TISSUES WITH THEM. PT HAS NOT HAD ANY DACRYOCYSTITIS. PT'S RIGHT EYE ALSO SEEMS WET AT TIMES, ALTHOUGH IT IS NOT AS BAD AS THE LEFT. PT HAS NOT HAD ANY PREVIOUS NASAL OR SINUS SURGERY. PT HAD GRAVE'S DISEASE ABOUT 5 YEARS AGO. THIS CAUSED PT DOUBLE VISION AND THEY HAD STRABISMUS REPAIR WITH A GOOD RESULT. PT ALSO HAS A HISTORY OF SJOGREN'S SYNDROME WITH DRY EYES. PT HAS HAD A MITRAL VALVE PROLAPSE AND AN IRREGULAR HEART BEAT. ON EXAM, DR DID NOTICE THAT THE TEAR FILM WAS INCREASED ON THE LEFT EYE. EACH INFERIOR PUNCTUM WAS CLOSED AND THE PT BELIEVES THAT DR MAY HAVE PERFORMED CAUTERY TO CLOSE THE PUNCTA TO TREAT DRY EYE PROBLEM ABOUT 2 YEARS AGO. DID IRRIGATE THROUGH SUPERIOR PUNCTUM ON LEFT SIDE AND COULD GET SOME FLUID TO PASS INTO THE NOSE. HOWEVER, THERE WAS RESISTANCE TO THE IRRIGATION. DR DID PROBE THE SUPERIOR CANALICULUS AND THOUGHT THEY COULD FEEL A SCAR AT THE INTERNAL COMMON PUNCTUM AREA. ENDOSCOPY WAS PERFORMED AND THIS DID SEEM TO SHOW ROOM ENOUGH FOR A DCR TO FUNCTION. DR DID NOT NOTICE ANY LOWER LID ENTROPION. PT DOES HAVE LEFT SIDED EPIPHORA. LIKELY CAUSES FOR THIS INCLUDE THE CLOSED INFERIOR PUNCTUM, A COMMON CANALICULAR SCAR, AND PERHAPS A NASOLACRIMAL DUCT OBSTRUCTION. PT DOES HAVE A HISTORY OF DRY EYE SYNDROME. DR DID CAUTION PT THAT ONE HAZARD OF TRYING TO OPEN THE TEAR DUCTS WOULD BE THAT THEIR EYE MIGHT GO BACK TO BEING TOO DRY INSTEAD OF BEING TOO WET. PT SAYS THAT THE WET EYE BOTHERS THEM MORE THAN THE DRY EYE DID. DR ENCOURAGED PT TO GIVE THIS SOME FURTHER THOUGHT AND PT SAID THEY WOULD DO SO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HERRICK LACRIMAL PLUG LACRIMAL OCCLUSION DEVICE HMX LACRIMEDICS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention