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The following documentation applies only to Parasol Sterile Pre-Loaded punctal occluders (product numbers A14-200, A14-201, A14-202 and A14-203).

INTRODUCTION
The Parasol Punctal Occluder is designed to provide a simple, reversible means of long term punctal occlusion by reducing or eliminating tear drainage via the punctum. The occluder is easy to insert and comfortable for the patient after placement.
    Dilation of the punctum and the use of topical anesthetic with this device may not be required for insertion. However, a drop of ocular lubricant may be placed on the occluder to help facilitate insertion. When properly inserted, the occluder’s ultra thin dome should be visible at the punctal opening. (see FIGURE 1)

PATIENT DISCLOSURE
As with any procedure, punctal occlusion, or use of the Parasol occluder and other treatment alternatives have benefi ts and risks. Prior to use, always review these benefi ts and risks with your patients.

INDICATIONS FOR USE
Punctal occluders (plugs) are indicated for the treatment of “Dry Eye” Syndrome. “Dry Eye” being a condition where there is insuffi cient lubrication in the eye and the conjunctiva becomes much less moist than normal. This produces pain and discomfort in the eyes. This may occur in any condition that causes scars of the cornea, such as erythema multiform, trachoma, or corneal burns, etc. Other patients that may benefi t are: cataract patients, patients with arthritis, patients medicated for hypertension, contact wearers of any age, seasonal allergy sufferers, patients who live in dry climates, or spend extended periods in air conditioning, and any others who suffer from dry eye irritation. Treatment is to stop tear outfl ow via a specifi c punctum to enhance tear contact time in certain dry eye conditions. It is also reasonable that medications could be enhanced if retained for a longer period of time on the surface of the eye.

CONTRAINDICATIONS
Tearing, secondary to chronic dacryocystitis with mucopurolent discharge, infl ammation of the eyelid, and/ or epiphora. The lacrimal system should be evaluated for blockage by irrigation before occlusion is performed.
    It is also reasonable that eye drops of many kinds would be more effective if retained on the surface of the eye, rather than drained into the sinus.

SIZING
Due to the design of the Parasol Punctal Occluder, two sizes (small and medium) fit virtually all patients. The Parasol is also available in an extra-small size for unusually small puncta, and a large size for unusually large puncta. In most instances, visual evaluation and clinical experience are sufficient for punctal sizing. It is always important to evaluate both punctas, since variance in punctal size within patients is a possibility. (see FIGURE 2)

DILATION
The Parasol Punctal Occluder System was designed to minimize punctal dilation requirements. The Parasol is a self-dilating plug, therefore insertion should fi rst be attempted without dilation. In most circumstances, little if any punctal dilation is necessary. If dilation is required, using the dilator end of the inserter, gently insert the dilator tip into the punctum. Remove and promptly insert the Parasol plug.

INSERTION
The disposable inserter has been designed to make the insertion process as easy as possible.
    Holding the insertion instrument comfortably between your thumb and forefi nger, orient your intended “trigger fi nger” over the release button. This will insure a smooth release of the occluder without having to adjust your fi nger position once the occluder is properly seated. Note: Care should be taken not to prematurely release the occluder. The release button should be pressed only after the occluder is in its desired position. Positioning the plug end of the insertion instrument over the patient’s punctum, gently insert the plug into the punctum until the dome is fl ush with the lid margin. (see FIGURE 3) Once you have determined the plug is in its proper position, depress the release button on the inserter. (see FIGURE 4) After insertion, carefully inspect the punctal area to confi rm the occluder has been properly placed for optimum occlusion.

REMOVAL
If removal of the occluder is indicated, gently grasp the vertical shaft immediately underneath the exposed dome with forceps. (see FIGURE 5) Gently pull upward using a rocking motion until the plug is fully released from the punctum.

CAUTIONS
U.S. Federal law restricts this device for sale by or on the order of a licensed physician.
    Care should be used when dilating the patient’s puncta in order to prevent perforating the punctum or canaliculus.
    Incidents of foreign body sensation, irritation, swelling, epiphora, pain, and granuloma have been reported after punctal occlusion in some patients. In the event of these occurrences, the patient should be re-evaluated and considered a candidate for plug removal.
    Punctal occlusion could enhance the effect of ocular medications. Therefore, consideration must be given to the proper dosage of such medications in the presence of occluders.

WARNINGS
The device is intended only for Single Patient Use. Sterility is not guaranteed if the package has been opened or damaged.

STORAGE CONDITIONS
Store at room temperature.

PRODUCT INFORMATION
Each tray contains two STERILE punctal occluders, each pre-loaded onto a disposable inserter/dilator and individually sealed to prevent contamination. Each occluder is made of medical grade silicone.

OP-NOTES™ DOCUMENTATION LABELS
For your convenience, Odyssey provides handy peeland- stick labels with each pack of occluders. Each label contains plug size, lot number, and coding information and can be readily applied to your patient’s fi le, billing record, surgery notes, or wherever a precise record of product is needed. The information provided on the Op- Notes is also useful and necessary when communicating with our customer service department regarding product performance.