|PUNCTAL OPENING||VERAPLUG™ SIZE|
|0.2mm to 0.3mm||X-Small|
|0.3mm to 0.5mm||Small|
|0.6mm to 0.8mm||Medium|
|0.9mm to 1.0mm||Large|
Sterile Preloaded Punctal Occlusion System
The VeraPlugTM FlexFitTM 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 FlexFitTM punctal occluder is molded from medical grade silicone. The VeraPlugTM FlexFitTM is available in four sizes (x-small, small, medium, and large) and is packaged sterile, two per box. Each occluder is sterile, preloaded on an inserter.
Indications for Use
The VeraPlugTM FlexFitTM is for use in patients with dry eye syndromes.
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, in ammation of the eyelid, and epiphora.
The VeraPlugTM FlexFitTM may enhance the e ect of 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 VeraPlugTM FlexFit,TM the occluder should be removed.
Potential Adverse Events
The following complications may occur:
Each box contains two individually packaged sterile VeraPlugTM FlexFitTM punctal occluders preloaded on inserters for single use only. The VeraPlugTM FlexFitTM is manufactured from implant grade silicone.
Proper sizing can be determined by using a 0.3mm gauge. If the gauge tip is snug in the punctum, then a small size occluder is required. If there is no resistance to the gauge then the next larger size should be tried. If resistance is extremely tight, an x-small size occluder should be used.
Anesthetize the area of the punctum with a topical anesthetic placed in the conjunctival sac.
Apply a drop of saline solution or artificial tears onto the VeraPlugTM to help ease insertion.
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.
Vertically insert the VeraPlugTM by positioning the occluder into the punctum until the cap is flush with the punctal opening. FIGURE A
When the occluder is properly seated, depress the release button and withdraw the insertion instrument. FIGURE B
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.
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
VeraPlugTM FlexFit sterile preloaded punctal occluders are o ered in individual trays, two per box. The date of expiration should be confirmed prior to use. If the expiration date has lapsed the occluder should be discarded.
Store at 15-30° Celsius.
The VeraPlugTM FlexFit 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. U.S. federal law restricts the sale of this device by or on the order of a physician.
Each box contains Instructions for Use and two labels for your ease and convenience.
Note: All products sold on Accuspire.com should be used by qualified clinician and and should be purchased by or on order of a qualified clinician.
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