BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HERRICK LACRIMAL PLUG

    MDR report key: 268075 · Received March 8, 2000

    Report

    Report Number
    MW1018361
    Event Type
    Injury
    Date Received
    March 8, 2000
    Date of Event
    April 29, 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. SURGERY WILL BE REQUIRED TO CORRECT THE ADVERSE EVENT. PT COMPLAINS OF EYES BEING TOO WET AT TIMES AND FREQUENTLY BEING IRRITATED. PT IS HAVING DIFFICULTY WEARING CONTACT LENS CORRECTION FOLLOWING REFRACTIVE CORNEAL SURGERY 2 YEARS AGO. PT DID UNDERGO REPAIR OF A RETINAL DETACHMENT IN THEIR LEFT EYE IN 1991 FOLLOWING A PREVIOUS REPAIR. APPARENTLY PT IS SOMEWHAT UNDER CORRECTED FOLLOWING THE REFRACTIVE SURGERY AND NEEDS TO WEAR CONTACT LENSES IN ORDER TO HAVE GOOD VISION. PT SAYS THAT IT HAS BEEN QUITE DIFFICULT TO WEAR THE CONTACT LENSES BECAUSE OF THE PROBLEMS OF IRRITATION, DRYNESS AND EXCESSIVE TEARING. IN ORDER TO TREAT THE DRY EYE DIFFICULTY, DR DID PLACE HERRICK PLUGS IN THE RIGHT INFERIOR, LEFT INFERIOR, AND LEFT SUPERIOR PUNCTA. THIS SEEMS TO HAVE WORKED WELL ON THE RIGHT SIDE, BUT PT HAS HAD SOME EPIPHORA ON THE LEFT SIDE FOLLOWING PLACEMENT OF THE PLUGS. ON EXAMINATION, PT DID HAVE QUITE SIGNIFICANT UPPER EYELID RETRACTION. THE LEFT UPPER LID MARGIN WAS ABOUT 4 MM ABOVE THE LIMBUS MOST OF THE TIME AND THE RIGHT UPPER LID MARGIN WAS APPROXIMATELY 3 MM ABOVE THE LID MARGIN. THERE WAS SOME VARIATION OF THE UPPER LID HEIGHT, BUT ON AVERAGE THERE CLEARLY WAS SCLERAL SHOW MOST OF THE TIME. THE OCULAR MOTILITY WAS RELATIVELY NORMAL, BUT DR DID THINK THERE MIGHT BE SOME RESTRICTION OF UP GAZE ON BOTH SIDES. IN REGARD TO THE TEAR DUCTS, DR COULD SEE TISSUE IN THE INFERIOR PUNCTUM AND CANALICULUS ON THE RIGHT SIDE. DR THOUGHT THIS MIGHT REPRESENT SOME GRANULATION TISSUE AROUND THE HERRICK PLUG. DR WAS ABLE TO IRRIGATE THROUGH THE RIGHT SUPERIOR CANALICULUS INTO THE NOSE WITHOUT ANY DIFFICULTY. ON THE LEFT SIDE, DR DID TRY TO IRRIGATE BOTH THE INFERIOR AND SUPERIOR CANALICULI AND FOUND THAT FLUID DID NOT PASS INTO THE NOSE BUT CAME BACK ALONG THE IRRIGATING CANNULA. PT HAS UPPER EYELID RETRACTION. DR'S THOUGHT IS THAT THIS MOST LIKELY IS DUE TO GRAVES' OPHTHALMOPATHY. THIS COULD CERTAINLY BE A FACTOR IN CAUSING THEIR EYE IRRITATION AND DIFFICULTY CLOSING LIDS AT NIGHT TIME, AND DISCOMFORT IN WEARING CONTACT LENSES. INTERESTINGLY, PT'S SPOUSE HAS HAD GRAVES' DISEASE AND DID SEE AN ENDOCRINOLOGIST ABOUT THIS. DR ASKED PT TO CHECK WITH THEIR PRIMARY CARE PHYSICIAN TO SEE WHETHER THEY AGREED THAT IT WOULD BE REASONABLE FOR PT TO SEE THE SAME ENDOCRINOLOGIST WHO HELPED THEIR SPOUSE. ASSUMING THERE IS NO TREATMENT REQUIRED FOR THYROID GLAND. DR DOES THINK THAT REPAIR OF THEIR UPPER EYELID RETRACTION MIGHT HELP TO MAKE EYES COMFORTABLE AND MORE TOLERANT OF CONTACT LENS WEAR. IN REGARD TO THE TEARING ISSUE, DR DOES THINK THAT THE PLUGS ARE LIKELY RESPONSIBLE FOR THE EPIPHORA ON THE LEFT SIDE. EVEN THOUGH THIS IS A NUISANCE, DR DOES THINK THAT IT IS HELPFUL AT THE PRESENT TIME TO MAINTAIN ENOUGH MOISTURE ON THEIR EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HERRICK LACRIMAL PLUG LACRIMAL OCCLUSION DEVICE HMX LACRIMEDICS, INC. 0.5 MM SHAFT PLUGS *

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention