DOSAGE AND ADMINISTRATION
Cataract Surgery - IOL Implantation
A sufficient amount of the Healon OVD is slowly, and carefully introduced (using a cannula or needle) into the anterior chamber.
Injection of the Healon OVD can be performed either before or after delivery of the lens. Injection prior to lens delivery will, however, have the additional advantage of protecting the corneal endothelium from possible damage arising from the removal of the cataractous lens5.The Healon OVD may also be used to coat surgical instruments and the IOL prior to insertion.
Additional Healon OVD can be injected during surgery to replace any Healon OVD lost during surgical manipulation (see PRECAUTIONS section).
Glaucoma Filtration Surgery
In conjunction with performing of the trabeculectomy, the Healon OVD is injected slowly and carefully through a corneal paracentesis to reconstitute the anterior chamber. Further injection of the Healon OVD can be continued allowing it to extrude into the subconjunctival filtration site and through and around the sutured outer scleral flap.
Corneal Transplant Surgery
After removal of the corneal button, the anterior chamber is filled with the Healon OVD.The donor graft can then be placed on top of the bed of Healon OVD and sutured in place.Additional Healon OVD may be injected to replace the Healon OVD lost as a result of surgical manipulation (see PRECAUTIONS section).The Healon OVD has also been used in the anterior chamber of the donor eye prior to trepanation to protect the corneal endothelial cells of the graft5.
Retinal Attachment Surgery
The Healon OVD is slowly introduced into the vitreous cavity. By directing the injection, the Healon OVD can be used to separate membranes (e.g. epiretinal membranes) away from the retina for safe excision and release of traction.The Healon OVD also serves to maneuver tissues into the desired position, e.g. to gently push back a detached retina or unroll a retinal flap, and aids in holding the retina against the sclera for reattachment.
Sterile Opening Technique
Tear off the paper covering.
Bend the plastic backwards at the
central indentation so as to fully
expose the white plastic rod.
Dislodge syringe and place onto
Press the vial completely into the holder so that the needle perforates the membrane.
Perforate the membrane before screwing on the plastic rod.
Remove the plastic rod.
Screw the plastic rod into the blue plunger.
Connect the cannula and check for proper function.
Store at 2 to 8°C (36 to 46°F). For single use only
The Healon OVD is a sterile, nonpyrogenic, viscoelastic preparation supplied in disposable glass syringes, delivering 0.85 mL, 0.55 mL or 0.4 mL sodium hyaluronate (10 mg/mL) dissolved in physiological sodium chloride phosphate buffer (pH 7.0-7.5). Each mL of Healon OVD contains 10 mg of sodium hyaluronate, 8.5 mg sodium chloride, 0.28 mg of disodium hydrogen phosphate dihydrate, 0.04 mg of sodium dihydrogen phosphate dihydrate and q.s. water for injection U.S.P.The Healon OVD syringes are terminally sterilized and aseptically packaged.
A sterile single-use 27 G cannula is enclosed in the 0.4 mL, 0.55 mL, and
0.85 mL boxes.
Refrigerated Healon OVD should be allowed to attain room temperature (approximately 30 minutes) prior to use.
For intraocular use.
Store at 2 to 8°C (36 to 46°F).
Protect from freezing.
Protect from light.
Federal law restricts this device to sale by or on the order of a physician.
Definition of symbols on cannula, syringe-, blister label and carton.
1. Richter,W., Ryde, M. & Zetterström, O.: Nonimmunogenicity of a purified sodium hyaluronate preparation in man. Int Arch Appl Immun 59:45-48 (1979).
2. Balazs, E.A.: Ultrapure hyaluronic acid and the use thereof.
U.S. Patent 4, 141, 973 (1979).
3. Balazs, E.A., Miller, D & Stegmann, R.:Viscosurgery and the use of Na-hyaluronate in intraocular lens implantation. Lecture, Cannes, France (1979).
4. Miller, D. & Stegmann, R.: Use of Na-hyaluronate in anterior segment eye surgery. Am Intra-Ocular Implant Soc J 6 (1980b) p 13-15.
5. Pape, L.G. & Balazs, E.A.:The use of sodium hyaluronate (Healon®) in human anterior segment surgery. Ophthalmol 87 (1980) p 699-705.
6. Richter,W.: Non-immunogenicity of purified hyaluronic acid preparations tested by passive cutaneous anaphylaxis. Int Arch All 47 (1974) p 211-217.
Manufactured by: AMO Uppsala AB, Rapsgatan 7, Box 6406, SE-751 36 Uppsala, Sweden. Revised: May 2014