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Instructions for Use

Mechanisms:

BioCorneaVet is indicated for use in the treatment of several epithelial corneal defects and diseases including, but not limited to, ocular trauma, deep corneal ulceration, perforation and feline sequestrum formation. BioCorneaVet's primary surgical method of implantation is by anterior lamellar keratoplasty (ALK or DALK). When covering corneal defects, BioCorneaVet promotes host corneal epithelial regeneration and matrix synthesis. Healing results when the cornea is fully restored in the aspects of structure and function as normal cornea.

Surgical Techniques:

1. Preparation before use: Appropriate debridement is performedby removing unhealthy corneal tissue under the operating microscope. Descemet’s membrane, corneal endothelium and minimal posterior corneal stroma are preserved after the debridement. Remove all corneal debris and avoid cauterization to stop bleeding and wash the wound bed with normal saline.

2. How to use: Open the outer sterile package and withdraw the inner one. Under the aseptic conditions, the inner box is removed. A proper amount of normal saline is infused into the inner box to rehydrate the product for one minute. Next, the product is placed with the convex surface side facing upward onto the wound bed evenly. 9-0 sutures are then employed to fixate the matrix graft in place. Surgical procedures, medications and therapeutic postoperative care follow the same as with the regular lamellar keratoplasty. 

3. Postoperative observation: Closely observe the signs and symptoms of rejection response including ocular pain, increased secretions, excessive tearing, edema, and growth of new vessels surrounding the cornea. Corresponding interventions should be carried out in a timely manner if necessary.

4. After discharge: Attention to protecting the affected eye and the prevention of infection is of utmost concern.

Indications:

Corneal diseases, ulcerations, descemetocele, perforations, feline corneal sequestrum, and trauma where pharmaceutical interventions and/or temporary ocular bandage coverage have failed or are of no use.

Contraindications:

1. Severe uncontrolled infection on conjunctival sac, lacrimal sac and meibomian gland.

2. Moderate or severe dry eye.

Precautions:

1. BioCorneaVet should be used immediately after open.
2. If any signs of infection are noted after use, routine anti-infective interventions should be carried out.
3. Any allergic reactions are noticed during the treatment, the primary surgeon should be informed.
4. The use of this product should be directed under the guidance of LICENSED VETERINARIAN.
5. The use of this product should be IN STRICT ADHERENCE TO THESE GUIDELINES 6. Those with immunological corneal ailments should be TREATED with caution.
7. Those with uncontrolled glaucoma should be used with caution.
8. Follow the routine of medical waste management when the product is discarded.

Storage and Transportation:
This product should be stored and transported at a temperature between 2
°C-25°C.

Shelf Life: Eighteen months