Indications: The HEALON Duet® Dual Pack consists of the cohesive HEALON® OVD and the dispersive HEALON EndoCoat® OVD. The HEALON Duet® Dual Pack provides two viscoelastic products with different physiochemical properties that are intended to perform specific tasks during the cataract procedure. The products in the HEALON Duet® Dual Pack maintain a deep chamber during anterior segment surgery, aid in tissue manipulation, enhance visualization, and protect the corneal endothelium and other ocular tissues during cataract surgery.
Important Safety Information – HEALON® OVD
PRECAUTIONS: Do not overfill the chamber of the eye with HEALON® OVD. Using excessive amounts of HEALON®OVD may cause an increase intraocular pressure (IOP), glaucoma, or other ocular damage. Special care should also be taken when treating aphakic diabetic patients to avoid using large amounts of HEALON® OVD. Postoperative intraocular pressure may also increase as a result of preexisting glaucoma, compromised outflow, and operative procedures. Carefully monitor intraocular pressure especially during the immediate postoperative period. Treat with the appropriate therapy if a significant increase in intraocular pressure is observed. Remove some of the HEALON® OVD by irrigation or aspiration at the close of surgery, except in glaucoma surgery. Avoid trapping air bubbles. Use only if the solution is clear. Because the HEALON® OVD is a highly purified fraction extracted from avian tissues, and is known to contain amounts of protein, the physician should be aware of the potential risks of the type that can occur with the injection of any biological material. ADVERSE EVENTS: Side effects of using HEALON® OVD may include a transient rise in intraocular pressure postoperatively, particularly in aphakic diabetic patients after injection of large amounts of HEALON® OVD. Other rare reactions may include postoperative inflammatory reactions (iritis, hypopyon), incidents of corneal edema and corneal decompensation.
Important Safety Information – HEALON EndoCoat® OVD
WARNINGS: The HEALON EndoCoat® OVD Delivery System is not designed or intended to be attached to other instruments other than the one provided with this product. Failure to follow the “Directions of Use” may result in cannula detachment. Mixing 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 when using HEALON EndoCoat® OVD during surgery. PRECAUTIONS: Preexisting glaucoma, the surgery itself, or retained viscoelastic, especially in patients with compromised trabecular meshwork, can cause an increase in intraocular pressure after the procedure. Do not use excessive amounts of HEALON EndoCoat® OVD. Remove HEALON EndoCoat® OVD completely from the anterior chamber of the eye after the surgery. The intraocular pressure should be carefully monitored particularly at the early postoperative period. Corrective therapy should be administered if an increase in postoperative intraocular pressure occurs. Use only if the solution is clear. Avoid trapping air bubbles. Do not use in cases of known hypersensitivity to any ingredients of the products. HEALON EndoCoat® OVD does not require refrigeration. If refrigerated, the HEALON EndoCoat® OVD should be allowed to attain room temperature prior to use. ADVERSE EVENTS: Potential side effects of using HEALON EndoCoat® OVD may include postoperative intraocular inflammation and an increase in ocular pressure, corneal edema, and corneal decompensation.
CAUTION: Federal law restricts these devices to sale by on or the order of a physician.