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The following documentation applies only to Odyssey EXTEND Absorbable Synthetic Punctal Implants (product numbers A13-200, A13-203, A13-204 and A13-205).

DESCRIPTION
Odyssey Medical's Extend Absorbable Synthetic Punctal Implants are short-term implants designed to be inserted through the punctal opening into the canaliculus in order to block tear drainage through the lacrimal drainage system. The implants are made from an absorbable copolymer of glycolic acid and trimethylene carbonate. The implants are dyed with D&C Green Number 6.
    Extend Absorbable Synthetic Punctal Implants are available in three diameters: 0.3mm, 0.4mm and 0.5mm. A variety pack is also available with a combination of all three sizes. The implants are supplied sterile with two implants per package, so that an implant can be placed into each canaliculus. Absorption time =< 3 months based on results obtained in an animal study.

INDICATIONS
Extend Absorbable Synthetic Punctal Implants are intended for temporary 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 canaliculus. They may be used in the treatment of dry eye syndrome and the dry eye components of various ocular surface diseases.
    When indicated, Extend Absorbable Synthetic Punctal Implants may also be used after surgery on the eye to prevent complications due to dry eye and to enhance the retention of ocular medication on the eye.

CONTRAINDICATIONS
Odyssey Medical's Extend Absorbable Synthetic Punctal Implants are contraindicated for patients with known sensitivities or allergies to glycolic acid or trimethylene carbonate and for patients who are experiencing epiphora, inflammation of the eye lid or tearing secondary to dacryocystitis with mucopurolent discharge. The implants are not intended for prophylactic use and should only be prescribed if dry eye symptoms are present.

INSERTION
• Prior to the insertion of an Extend Absorbable Synthetic Punctal Implant, inspect the patient's punctum to determine the appropriate diameter implant to use.
• Open the sterile Tyvek pouch and remove the implant from the blue foam holder using jeweler's forceps.
• A small amount of lubricant may be used on the implant or punctum in order to facilitate insertion into the punctum.
• Grasping the implant with jeweler's forceps, insert the Extend Absorbable Synthetic Punctal Implant partially through the punctal opening.
• Release the implant and use the tip of the forceps to push the implant the rest of the way through the punctal opening and into the canaliculus.
• Following insertion, inspect the punctal opening to ensure the implant is below the punctal opening.

CAUTIONS
Odyssey Medical's Extend Absorbable Synthetic Punctal Implants 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.
    Care should be used not to perforate the punctum or canaliculus while inserting Extend Absorbable Synthetic Punctal Implants. Perforations may cause pain and increase the risk of infections. If perforation occurs, delay the placement of the implant until the wound heals.
    If the patient experiences irritation, infection or epiphora after insertion of an Extend Absorbable Synthetic Punctal Implant, the implant should be removed. Saline irrigation or probing may be used to expel the implant through the lacrimal drainage system into the nose or throat.
    Federal law (USA) restricts this device to sale by or on the order of a physician.