INDICATIONS AND IMPORTANT SAFETY INFORMATION
FOR THE HEALON ENDOCOAT® OVD
Federal law restricts this device to sale, distribution and use by or on the order of a physician.
HEALON EndoCoat® OVD is an ophthalmic viscoelastic containing 3% sodium hyaluronate indicated for use as a surgical aid in patients undergoing ophthalmic anterior segment procedures including:
- Cataract surgery with an intraocular lens.
- Cataract surgery without an intraocular lens.
- Secondary intraocular lens implantation.
HEALON EndoCoat® OVD maintains a deep chamber during anterior segment surgery, aids in tissue manipulation during surgery, enhances visualization during the surgical procedure and protects the corneal endothelium and other ocular tissue. The viscoelasticity of the solution maintains the normal position of the vitreous face and prevents formation of a flat chamber during surgery. It may also be used to coat intraocular lenses and insertion instruments prior to intraocular lens implantation.
At present, there are no contraindications to the use of HEALON EndoCoat® OVD when used as recommended.
The HEALON EndoCoat® OVD Delivery system is not designed or intended to be attached to instruments other than the one provided with the product. Failure to follow the "Directions for Use" may result in cannula detachment. Mixing of quaternary ammonium salts, such as benzalkonium chloride, with sodium hyaluronate results in the formation of a precipitate. The eye should not be irrigated with any solution containing benzalkonium chloride if HEALON EndoCoat® OVD is to be used during surgery.
Injection of viscoelastics creates pressure in the syringe. To prevent expulsion of the cannula into the eye, ensure that the cannula is securely attached to the fitting on the syringe. Use of the cannula guard is recommended. The cannula should be fastened securely to the syringe; however, over tightening may cause the hub to weaken and possibly detach from the syringe. Extrusion of a test droplet is recommended prior to entering the eye, and excessive force on the plunger should be avoided. Do not reuse the cannula. This could release particulate matter. Product and cannula are for single use only. Re-use may cause eye inflammation. The potential for early and short-term postoperative intraocular pressure (IOP) spikes exists with dispersive OVDs, which potentially require more time and care to remove from the eye. Therefore, it is recommended that HEALON EndoCoat® OVD be removed from the eye completely by irrigating and aspirating with sterile irrigation solution to reduce the risk of early postoperative IOP spikes. Observe the usual precautions taken during anterior segment surgery. Pre-existing glaucoma, the surgery itself, or retained viscoelastic (particularly in patients with compromised trabecular meshwork) can cause increased intraocular pressure after the procedure. The following precautions should be carefully considered:
- The intraocular pressure of postoperative patients should be carefully monitored, particularly in the early post operative period.
- Do not use excessive amounts of HEALON EndoCoat® OVD.
- Remove HEALON EndoCoat® OVD completely from the anterior chamber at the end of the procedure.
- Corrective therapy should be initiated if the postoperative intraocular pressure rises above safe levels.
- For intraocular use only.
- Store at 2-25°C (36-77°F).
- Protect from freezing.
- Protect from light.
- Use only if solution is clear.
- Avoid trapping air bubbles.
- Contents are sterile when the package is sealed and undamaged.
- Use aseptic technique.
- Do not use in cases of known hypersensitivity to any of the ingredients of this product.
- See product expiration date.
HEALON EndoCoat® OVD does not require refrigeration. If refrigerated, HEALON EndoCoat® OVD should be allowed to attain room temperature prior to use. There have been isolated reports of diffuse particulates or haziness appearing after injection of viscoelastics into the eye. While such reports are infrequent and seldom associated with any effects on ocular tissue, the physician should be aware of this occurrence. If observed, the viscoelastic should be removed by irrigation and/or aspiration. HEALON EndoCoat® OVD is derived from microbial fermentation by a purified proprietary process. Although precautions have been taken to make this device protein-free, it may contain trace amounts of protein. The physician should be aware of the potential allergic risks such as postoperative inflammation that can occur with injection of biological materials.
Because sodium hyaluronate is a polysaccharide present in many tissues of the body, it is extremely well tolerated in human eyes. There have been reports of transient postoperative ocular inflammation (oral and/or topical steroid treatments were administered) and transient postoperative increases in intraocular pressure during clinical trials with viscoelastics. In addition to the above, the following adverse reactions have been reported following the use of sodium hyaluronate in intraocular surgery: inflammation, corneal edema, increased intraocular pressure, secondary glaucoma and corneal decompensation. All of the adverse reactions described above are potential adverse reactions for HEALON EndoCoat® OVD.
During the clinical trial, elevated intraocular pressure ≥ 30 mmHg occurated at a rate of 10.5% in the HEALON EndoCoat® OVD group, and treatment of cystoid macular edema (CME) occurred at a rate of 0.5%.