CE眼科(OVD)

(Ophthalmic Viscosurgical Device)0434

Instruction for use

Content:

Sterile single-use syringe with sodium hyaluronate solution and single-use ophthalmic cannula. Secure attachment of the cannula to the syringe is assured by the BD Luer-Lock fitting on the tip of the syringe.

Composition:

Each ml contains:

Sodium hyaluronate13.0/15.0mg

Sodium chloride9.0mg

Disodium hydrogenphosphate0.81 mg

Sodium dihydrogenphosphate0.075mg

Water for injectionq.s

Description:

This product is a sterile, isotonic, pyrogen-free, viscoelastic solution of highly purified sodium hyaluronate, to be delivered into anterior chamber of eye by sterile single-use syringe. It is packed in a sterile blister or edge-sealed pouch.

Characteristics:

Sodium hyaluronate is a long chain polysaccharide made up of repeating disaccharide units, which occurs naturally in the human body.

It is a substance with high molecular weight, highly purified, and with favorable physical and rheological properties for ophthalmic surgery.

Hyaluronic acid is a biological and biocompatible substance. During ophthalmic surgery, it maintains the depth of the anterior chamber and allows lubrication, support and protection of ocular tissues.

Indications:

－Cataract surgery

－Glaucoma surgery

－Corneal transplant

Usage:

According to amount required for the operation, inject the product to anterior chamber, generally 0.1 to 0.3 ml, and add appropriate amount if the products leaked or ran out of the eye in different stage of operation. After operation, withdraw it and douche the anterior

chamber.

Contraindication:

None known at present.

Precautions:

Observe all usual precautions required during ophthalmic surgery .The physician should consider the immunological and other potential risks that can be associated with the injection of any biological material.