SOFT PLUG® Silicone, Preloaded 6 Pack, Small (0.7 mm), Pen-Style Inserter

Manufacturer Item #: 7713-D

About the Product

The distinctive low-profile cap combined with a softer, more flexible silicone maximizes patient comfort. The inserter provides greater control and minimizes the potential for accidental release of the plug. Soft Plug® silicone plugs are removable with forceps.

The OASIS Medical Silicone Punctal Plug is designed to be inserted into the punctal opening in order to control tear drainage through the canaliculus. Each punctum plug is molded from medical grade silicone.

The OASIS Medical Silicone Punctal Plug has a thin head portion designed to remain outside the punctum and rest on the eyelid. The central shaft portion of the plug has a smaller diameter than the head portion and is designed to fit through the punctal opening. The nose portion of the plug has a larger diameter which is designed to fit in the canaliculum in order to retain the plug in the punctum. Silicone punctal plugs are available in two styles: the original punctum plug with a closed nose portion which blocks flow through the punctal opening, and the Flow Control punctal plug with an opening through the nose portion which allows flow through the punctal opening.

Intended Use: The OASIS® Medical SOFT PLUG® Silicone and Flow Control Punctum Plugs are intended to be inserted into the punctal opening by a certified physician to totally or partially block tear drainage through the canaliculus.

Indications for Use: The OASIS® Medical SOFT PLUG® Silicone and Flow Control Punctum Plugs are indicated for use in patients experiencing dry eye symptoms such as redness, burning, reflex tearing, itching or foreign body sensations which can be relieved by blockage of the punctum.

Silicone Punctum Plugs may be used in the treatment of dry eye syndrome and the dry eye components of various ocular surface diseases such as corneal ulcers, conjunctivitis, pterygium, blepharitis, keratitis, red lid margins, recurrent chalazions, recurrent corneal erosion, filamentary keratitis and other external eye diseases.

Other patients that may benefit 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 irritation. It is 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.

Specifications

• Same silicone punctal plug now with a new choice of inserter
• Comfortably cradles between index and thumb
• Easy press and release plug placement
• More comfortable to the patient
• Less likely to dislocate
• Easier to remove should the need arise
• Multiple sizes
• Sterile, preloaded in 6-pack box

How to Use

Anesthesia: Anesthesize 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.

Proper Sizing: Determine the proper plug size prior to optional dilation. Start with the smallest gauge size (.5 mm). Gently insert the head of the gauge into the punctum, being careful not to go beyond the neck. When entering and leaving the punctal opening, the gauge head should slightly flex the punctal ring. If there is no resistance to the gauge, the next larger size should be tried. The gauge size is too large if there is substantial resistance and the tip is difficult to insert. The proper plug size is found when the punctal opening flexes moderately when the gauge is inserted and removed and the gauge tip is “snug” when in the punctum. In some patients, the left and right eyes may have different size punctum, therefore it is useful that the punctum of both eyes are measured.

Dilation (Optional): If dilating, gently dilate the punctum and quickly insert the silicone plug. If the plug is not inserted within 15 to 30 seconds, the dilation may need to be repeated.

Insertion: The OASIS® Medical SOFT PLUG® Silicone Punctum Plug comes pre-loaded on a disposable inserter. Use the inserter to position the plug across the punctum. Lubrication of the plug with saline solution or artificial tears eases insertion. Grasp the inserter on the non-compressible side to avoid compressing the plug out of the wire. Gently insert the plug- into the punctum until the cap is flush with the punctal opening. When the plug is properly inserted, gently squeeze and withdraw the inserter to release the plug. Observe and verify proper placement of the punctum plug. The nose of the plug should be beyond the punctum, the shaft of the plug should be through the punctum, and the cap of the plug should be outside the punctum and resting snug against the eyelid. If provided, insertion instructions are not followed, it can result in patient injury.

Warnings

Contraindications: The OASIS® Medical SOFT PLUG® Silicone Punctum Plug is contraindicated for patients experiencing inflammation of the eye lid, and tearing secondary to dacryocystitis with mucopurulent discharge.

If the patient experiences irritation, infection, or epiphora after insertion of a Silicone Punctum Plug, the plug should be removed by grasping the shaft of the plug below the exposed head with forceps and pulling the plug out of the punctal opening. The plug should not be removed by grasping the exposed head.

Cautions: Care should be used not to perforate the punctum or canaliculus during insertion of the Silicone Punctum Plug. Perforation may cause pain, increase the risk of infection and cause the plug to fall out easier due to an enlarged punctal opening or infection. If perforation occurs, delay the placement of the plug until the wound heals.

Inadequate or excessive forces, or improper technique used to insert the plug into punctum may cause loss of plug, lodging of plug beyond punctum into canaliculus, patient discomfort, or injury.

Patient intervention such as forceful rubbing of eyelids may result in dislodging of the plug. The OASIS® Medical SOFT PLUG® Silicone Punctum Plug may enhance the effect of ocular medication 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 resterilized. DO NOT USE if product is beyond the “use-by date”.

DO NOT USE if the sterile packaging is damaged. After use it should be properly disposed of according to medical waste guidelines of your facility.

While not necessary, additional patient care information is available on www.oasismedical.com.

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

Storage

Store between 0°C and 40°C (32°F to 104°F).