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The following documentation applies only to Odyssey Temporary Collagen Implants (product numbers A12-102, A12-103 and A12-104).

DESCRIPTION
Odyssey’s Collagen Intracanalicular Implants provide temporary lacrimal occlusion for patients experiencing dry eye symptoms and serves as a diagnostic tool in determining if permanent closure of the lacrimal drainage system will be of benefit to the patient.
The Odyssey Collagen Implants are made from absorbable material and are available in (3) sizes, 0.2mm x 2.0mm, 0.3mm x 2.0mm and 0.4mm x 2.0mm. There are (6) plugs per foam “sleeve” and (10) foam sleeves per box.
    The first 2-3 days post insertion of the collagen implant provides the most effective occlusion. Collagen will dissolve in approximately 7-10 days. The patient may experience great improvement of dry eye symptoms during the initial 3-7 days followed by a return to previous symptoms. Temporary improvement suggests the patient may benefit from permanent punctal occlusion with the Odyssey Punctal Occluder.

INTENDED USE
Odyssey’s Collagen Implants are designed to be inserted through the punctal opening into the canaliculus.

INDICATIONS
Collagen implants may be used in the treatment of dry eye syndrome, various ocular surface diseases, and dry eye related contact lens discomfort. When indicated, Odyssey Collagen Implants may be used before or after ocular surgery to prevent complications related to dry eye and to enhance the efficacy of ocular medications. Depending on the type of medications being used, dosage may need to be reduced accordingly.

CONTRAINDICATIONS
Odyssey’s Collagen Implants are contraindicated for patients allergic to bovine collagen or for patients with chronic dacryocystitis with mucopurolent discharge, inflammation of the eyelid and/or epiphora. The lacrimal system may be evaluated for blockage by irrigating with saline solution before occlusion is performed. Saline irrigation or probing after occlusion may be performed to expel the plug through the lacrimal sac into the nose or throat.

DIRECTIONS FOR USE
• Inspect the patient’s punctum to determine the appropriate size collagen implant.
• Remove the appropriate size implant from the foam sleeve using a pair of forceps.
• Grasp the implant with the forceps in one hand, using the other hand to steady the eyelid.
• Partially insert the implant into the canaliculus.
• Release the grip on the implant and use the tip section of the forceps to push the implant into the punctal opening and into the canaliculus, completing the process.
• Inspect the punctum to ensure the implant is fully inserted leaving no exposed collagen on the eyelid margin.

CAUTIONS
US Federal Law restricts this device for sale by or on the order of a medical physician. Care should be used not to perforate the punctum or canaliculus while inserting the Odyssey Collagen insert. If perforation occurs, delay the insertion process until the wound completely heals.

PRECAUTIONS
Contents are sterile if individual package is unopened or undamaged. Do not use if package has been previously opened.

STORAGE
Ambient conditions apply. Do not expose to extreme temperatures.