VeraPlug™ is Designed to provide a simple and effective treatment for chronic dry eye. Packaged nonsterile, 1 pair per poly bag, 10 pairs per box. Sterile inserters included.
- Conforms perfectly to the puncta for unparalleled retention
- Low-profile dome for enhanced patient comfort
- Proprietary shaft design for easy insertion and proper anatomic fit
- Available in four sizes
- Box of 20 plugs
- Size Chart
| PUNCTAL OPENING | VERAPLUG™ SIZE |
|---|---|
| 0.4mm to 0.6mm | Small |
| 0.6mm to 0.7mm | Medium |
| 0.7mm to 0.8mm | Large |
| 0.8mm to 1.0mm | X-Large |
VeraPlugTM - Instructions For Use - Please always refer to the insert in the box for latest information
Description The VeraPlugTM punctal occluder is designed to provide reduction or elimination of tear drainage through the inferior or superior puncta, thus maintaining lubricating tears on the surface of the eye. Each VeraPlugTM punctal occluder is molded from medical grade silicone. The VeraPlugTM is available in four sizes (small, medium, large and x-large) and is packaged sterile, two per box. Each occluder is sterile, preloaded on an inserter.
Indications for Use The VeraPlugTM is for use in patients with dry eye syndromes.
Contraindications Contraindications include, but are not limited to, eye infections, sensitivity or allergies to the occluder material and/or materials used in the manufacture of the device, blockage/infection of the lacrimal systems, inflammation of the eyelid, and epiphora.
Precautions The VeraPlugTM may enhance the e ect of some ocular medications in the eye. Depending on the type of medication being used the dose may need to be altered accordingly. If the patient experiences irritation, infection or epiphora after the insertion of the VeraPlug,TM the occluder should be removed.
Potential Adverse Events The following complications may occur: Epiphora, Pyogenic granuloma, Foreign body sensation, Infection of the lacrimal system, Plug dislodgement or migration possibly requiring surgical intervention, Washout, Punctal erosion
Each box contains ten pairs of VeraPlugTM punctal occluders for single use only. The VeraPlugTM is manufactured from implant grant silicone.
Proper Sizing - The VeraPlugTM punctal occluder is available in four sizes: small, medium, large and x-large. To determine the proper size, begin with the smallest VeraPlugTM gauge (0.5mm) and insert the head of the gauge into the punctal opening. The gauge should fit snugly with a small amount of resistance. If the gauge enters the punctal opening with no resistance, the next larger size gauge should be tried in the same manner. Repeat this process until the proper size VeraPlugTM is determined based on the sizing chart shown.
Sterilization Remove the occluders to be sterilized from the bag using forceps. Grasp the occluder at the shaft, place into an autoclavable pouch and seal. The VeraPlugTM can be sterilized using steam gravity type sterilization. The cycle temperature is 121°C (259°F) and cycle time is 30 minutes. The dry time is an additional 30 minutes. The entire cycle meets a SAL (Sterility Assurance Level) of 10-6.
Loading Load the sterilized occluder onto the sterile inserter using forceps. Grip the occluder by its shaft and carefully guide the inserter wire into the hole on the occluder cap. Secure the occluder on the inserter wire by placing the forceps onto the nose portion of the plug and pushing gently. The occluder is properly loaded when the wire has reached the end of the shaft to the point where it begins to taper.
Prior to Insertion Patients with intermittent tearing should receive probing and irrigation with a sterile irrigation solution to rule out pre-existing canalicular obstruction.
Insertion
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Anesthetize the area of the punctum with a topical anesthetic placed in the conjunctival sac.
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Apply a drop of saline solution or artificial tears onto the VeraPlugTM to help ease insertion.
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Position the insertion instrument by placing the forefinger on the release button of the inserter and placing the occluder end of the insertion instrument over the patient's (superior or inferior) punctum.
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Vertically insert the VeraPlugTM by positioning the occluder into the punctum until the cap is flush with the punctal opening. FIGURE A
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When the occluder is properly seated, depress the release button and withdraw the insertion instrument. FIGURE B
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Verify that the occluder is properly placed by confirming that the cap is flush with the punctal opening. FIGURE C After insertion, monitor the placement and integrity of the occluder to determine if/when the occluder may need to be replaced.
Removal Should removal be indicated, grasp the vertical shaft of the occluder underneath the exposed cap with sterile forceps. Gently pull upward until the plug is removed. FIGURE D above
Storage Store at room temperature. Warnings The VeraPlugTM punctal occluder is intended for single use. Do not reuse. If the sterile packaging is damaged or opened sterility is not guaranteed and the VeraPlugTM should be discarded. Documentation Each box contains Instructions for Use and 20 labels for your ease and convenience.
CAUTION: Federal (USA) law restricts this device to sale and use by, or on the order of, a physician.