BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HERRICK LACRIMAL PLUGS

    MDR report key: 260745 · Received February 1, 2000

    Report

    Report Number
    MW1018041
    Event Type
    Injury
    Date Received
    February 1, 2000
    Date of Event
    January 1, 2000
    Report Date
    January 15, 2000
    Manufacturer
    LACRIMEDICS, INC.
    Product Code
    LZU
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO REPORTER, HERRICK LACRIMAL PLUGS ARE UMBRELLA SHAPED PIECES OF SILICONE MARKETED TO PLACE IN THE INFERIOR PUNCTA TO OCCLUDE THE LACRIMAL SYSTEM OF DRY EYE PTS. THE LITERATURE FROM THE CO STATES THAT THE PLUGS CAN BE IRRIGATED ("SQUIRTED") THROUGH THE CANALICULI IF THEY NEED TO BE REMOVED. MANY CASES OF PERMANENT IRREVERSIBLE CANALICULAR OCCLUSION HAVE OCCURRED REQUIRING PT TO UNDERGO SURGERY TO EITHER REMOVE THE PLUG OR TO RECREATE ANOTHER LACRIMAL SYSTEM. THE DEVICE IS MARKETED PRIMARILY TO OPTOMETRISTS WHO CANNOT PERFORM REVERSIBLE SURGICAL OCCLUSIONS THAT MOST MD OPHTHALMOLOGISTS DO. THE DEVICE HAS CAUSED HARM TO MANY AND SHOULD BE REMOVED FROM THE MARKET. THIS PT RELATES HAVING TEARING FROM RIGHT EYE SINCE HERRICK PLUGS WERE PLACED. LEFT EYE IS DOING ALL RIGHT BUT RIGHT EYE CHRONICALLY TEARS. THE MORNINGS ARE WORSE THAN THE EVENINGS. ON TODAY'S EXAMINATION REPORTER FOUND THAT PT HAD BILATERAL DERMATOCHALASIA WITH LASH PTOSIS OU. DYE DISAPPEARANCE TEST WAS PROLONGED OU WITH THE RIGHT SIDE BEING MORE PROLONGED THAN THE LEFT. PUNCTA WERE PATENT AND IN THE TEAR LAKE OU. REPORTER TALKED WITH PT ABOUT OPTIONS. REPORTER SUGGESTED TRYING TO IRRIGATE THE HERRICK TUBE THROUGH THE CANALICULAR SYSTEM DURING TODAY'S EXAM. REPORTER DID TRY TO IRRIGATE THE TUBE THROUGH, BUT IT WOULD NOT BUDGE. REPORTER WAS ABLE TO IRRIGATE THROUGH THE SUPERIOR CANALICULAR SYSTEM. PT APPEARS TO HAVE WHAT COULD BE A PERMANENT AND COMPLETE INFERIOR CANALICULAR OBSTRUCTION. REPORTER STATES THAT EVIDENCE IS BECOMING AVAILABLE NOW TO INDICATE THAT THE HERRICK PLUGS ARE NOT AS A REVERSIBLE PROCEDURE AS THEY WERE ORIGINALLY THOUGHT. THE PLUGS THEMSELVES ARE SUCH THAT THEY COLLECT DEBRIS IN THE CANALICULAR SYSTEM CAUSING A LOW GRADE CHRONIC CANALICULITIS. THIS IN TURN LEADS TO MUCOSAL APPOSITION AND SOMETIMES CLOSURE OF THE CANALICULAR SYSTEM. REPORTER ASKED PT TO ALLOW REPORTER TO SEE PT BACK A FEW WEEKS FROM NOW. IF PT CONTINUES TO TEAR; THEN A MORE EXTENSIVE LACRIMAL PROCEDURE ADDRESSED AT INFERIOR CANALICULAR OBSTRUCTION WILL BE NECESSARY.

    Description of Event or Problem · 1

    ADD'L INFO RECEIVED FROM RPTR 3/1/00: ADD'L CORRESPONDENCE THAT RPTR HAS HAD WITH COLLEAGUES CONCERNING THE HERRICK LACRIMAL PLUGS. DOCUMENTS THIS HAS BEEN A PROBLEM FOR SEVERAL YEARS THAT HAS BEEN BROUGHT TO MFR'S ATTENTION WITHOUT ANY APPRECIABLE ACTION. A COLLEAGUE HAS BEEN CONCERNED ABOUT, THESE PLUGS SINCE 1996 WHEN FIRST BEGAN SEEING SERIOUS COMPLICATIONS WITH THEM. COLLEAGUE APPROACHED LACRIMEDICS EACH YEAR ONLY TO BE TOLD THAT NO SUCH PROBLEMS EXIST WITH THESE PLUGS. SUMMARIZING THE EXPERIENCES OF ABOUT 150 ASOPRS MEMBERS WITH HERRICK PLUGS, RPTR'S COLLEAGUE TOOK THE OPPORTUNITY TO SUMMARIZE THEIR PAPER IN AN ARTICLE WRITTEN FOR A COLUMN IN OPHTHALMOLOGY TIMES. IN WRITING THIS ARTICLE COLLEAGUE CAREFULLY STUDIES ALL THE MATERIAL PROVIDED BY LACRIMEDICS FOR USE BY OPTOMETRISTS AND OPHTHALMOLOGISTS AND PTS AND FOUND NO REFERENCES TO THE COMPLICATIONS SO MANY HAVE TREATED. EDITORS REFUSED TO PUBLISH THIS ARTICLE WITHOUT GIVING THE MFR (AN ADVERTISER) AN OPPORTUNITY TO RESPOND. COLUMN WAS FORWARDED TO MFR WHO ACTUALLY REWROTE IT, ESSENTIALLY DISMISSING THE RESULTS. COLLEAGUE REFUSED TO ALLOW THIS TO BE PUBLISHED AND WAS PLACED IN DIRECT CONTACT WITH MFR. AFTER GOING BACK AND FORTH A BIT, IN FINAL COMMUNICATION COLLEAGUE TOLD MFR THAT THEY BELIEVED THE RESPONSIBLE WAY TO HANDLE THE SITUATION WAS TO 1) IMMEDIATELY NOTIFY OPHTALMOLOGISTS AND OPTOMETRISTS THAT PREVIOUSLY UNRECOGNIZED COMPLICATIONS OF INTRACANALICULAR PLUGS HAVE BEEN REPORTED 2) CHANGE ALL OF THEIR LITERATURE, PREPARED CONSENT FORMS, ETC TO INCLUDE THE RISKS OF PERMANENT CANICULAR OBSTRUCTION AND DACRYOCYSTITIS WHICH MAY REQUIRE CDCR/DCR FOR REPAIR, AND 3) MAKE A SERIOUS EFFORT TO LEARN THE TRUE INCIDENCE OF THE PROBLEMS VIA SOME CAREFULLY ORGANIZED CLINICAL STUDIES. MFR FAILED TO RESPOND TO ANY OF THESE RECOMMENDATIONS AND COLLEAGUE HAS NOT HEARD FROM MFR SINCE. OPHTHALMOLOGY TIMES IS NOW IN THE PROCESS OF DOING AN "INVESTIGATIVE REPORT" IN WHICH THEY WILL SPEAK TO OCULOPLASTIC SURGEONS AND TO MFR. A SECOND COLLEAGUE HAD AN INTERESTING CONVERSATION WITH PRESIDENT OF THE CO THAT MFRS THE PLUGS. IT WOUND AROUND TO SAYING THAT MFR WASN'T SURE THAT IT WAS ACTUALLY HERRICK PLUGS THAT WERE THE PROBLEM. THIS SECOND COLLEAGUE SHARED THAT PERSONAL EXPERIENCE WITH REMOVING AT LEAST 4 PLUGS VIA CANALICULOSTOMIES OR DCR'S AND MFR SEEMED GENUINELY INTERESTED THAT THERE WERE SURGEONS WHO HAD ACTUALLY REMOVED AND IDENTIFIED THE PLUGS SURGICALLY. TWO ITEMS CAME OUT OF THIS CONVERSATION. ONE WAS THE POSSIBILITY THAT THESE PROBLEMS ONLY OCCUR WITH THE LARGER PLUGS. COLLEAGUE SEEMS TO RECALL REMOVING JUST THE LARGER PLUGS. SECONDLY, MFR SEEMS GENUINELY INTERESTED IN TALKING WITH OTHER SURGEONS WHO HAVE REMOVED HERRICK PLUGS AND 2ND COLLEAGUE WOULD ENCOURAGE ANYONE WITH FURTHER INFO/CONCERNS TO SHARE THESE WITH DIRECTLY. MFR WOULD RATHER DEAL WITH THIS ISSUE HEAD ON AND OUT IN THE OPEN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HERRICK LACRIMAL PLUGS DRY EYE TREATMENT DEVICE LZU LACRIMEDICS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention| S