FORM FIT Hydrogel Canalicular Plugs 10pk - One Size 0.3mm

About the Product

FORM FIT is truly a one size plug solution. Once inserted into the canaliculus, FORM FIT hydrates over a 10 minute period. As it hydrates, FORM FIT increases in size until it completely fills the vertical canalicular cavity.

How it works

FORM FIT is made of a hydrogel material that expands into a soft, pliable, gelatinous material when it contacts tear film. It takes approximately 10 minutes for the plug to become completely hydrated. FORM FIT securely conforms to the punctal cavity so there is no need for a cap or anchor system on the end of the plug. This greatly increases patient comfort and decreases foreign body sensation. FORM FIT does not begin to swell until it makes contact with tear film reducing the potential for product waste. FORM FIT is made from a hydrogel material that is safe and biocompatible.

Indications for Use: The OASIS Medical Form Fit® canalicular plug is intended for use in patients experiencing dry eye symptoms such as redness, burning, reflex tearing, itching or foreign body sensations which can be relieved by occluding the punctum. The Form Fit® canalicular plug may be used in the treatment of dry eye syndrome and the dry eye components of various ocular surface diseases. When indicated, the Form Fit® canalicular plug may be used after ocular surgery to prevent complications due to dry eye and to enhance the retention of topical ocular medications on the eye. Patients experiencing dry eye related contact lens problems may also be aided by the Form Fit ® canalicular plug.

Specifications

Pack	Manufacturer Item #	DER SKU
2pk	6303-T	RX-4156
10pk	6303	RX-4157

• Hydrates over a period of 10 minutes
• Requires no special storage
• Easily removed via irrigation of the tear duct
• Biocompatible, no foreign body sensation
• Conveniently pre-loaded on a user-friendly inserter
• 0.3mm, one size fits all

How to Use

Insertion: Anesthetize the area of the punctum with either a topical anesthetic instilled into the conjunctival sac or an anesthetic soaked, cotton tipped applicator held against the punctum for 30 seconds. A small amount of lubricant may be used on the punctum in order to facilitate insertion across the punctum.

Caution: Patency of the canaliculus should be determined prior to insertion of the Form Fit® plug. The OASIS Medical Form Fit® canalicular plug comes preloaded in a disposable inserter. Verify that the white Form Fit® plug has not fallen out of the inserter during shipping. Place the brown tip portion of the inserter through the puncta and squeeze the inserter to push the plug from the inserter tip into the canaliculus. The top edge of the plug should lie below the punctum opening. Forceps may be used to further push the Form Fit® canalicular plug to obtain the desired placement.

Removal: Should it be necessary to remove the Form Fit® canalicular plug, flush the mucus-like, gel plug from the canaliculus using a syringe filled with saline.

Place an injection cannula on the tip of the syringe, position the tip of the injection cannula through the puncta, and gently flush the canaliculus with saline.

Warnings

Contraindications: The OASIS Medical Form Fit® canalicular plug is contraindicated for patients experiencing epiphora, inflammation of the eye lid, and tearing secondary to dacryocystitis with mucopurulent discharge. If the patient experiences irritation, infection, or epiphora after insertion of the Form Fit® canalicular plug, the plug should be removed.

Precautions: Do not resterilize the Form Fit® canalicular plug by any method. Use only sterile intraocular irrigation solutions when required. Do not store Form Fit® canalicular plugs in excessively humid environments.

During implantation avoid getting the plug wet as this will cause it to expand. Avoid touching the plug or inserter tip to the patient’s eyelid prematurely.

Should an infection occur in the canaliculus, flush the mucus-like plug from the canaliculus and allow the infection to clear. The new Form Fit® plug may be inserted into the canaliculus after the infection clears.

Care should be used not to perforate the punctum or canaliculus during the insertion of the Form Fit® canalicular plug. Perforation may cause pain, increase the risk of infection, and cause the plug to fall out more easily due to an enlarged punctal opening or infection. If perforation occurs, delay the placement of the plug until the wound heals.

The Form Fit® canalicular plug may enhance the effects of ocular medications used on the eye. Depending on the type of medications being used, dosage may need to be reduced accordingly.

DO NOT REUSE. This is a single use, disposable, device that cannot be properly cleaned and re-sterilized.

Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.