INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE HEALON GV® OPHTHALMIC VISCOELASTIC DEVICE
Federal law restricts this device to sale, distribution and use by or on the order of a physician.
The HEALON GV® OVD is indicated for use in anterior segment ophthalmic surgical procedures. The HEALON GV® OVD creates and maintains a deep anterior chamber, to facilitate manipulation inside the eye with reduced trauma to the corneal endothelium and other ocular tissues. The HEALON GV® OVD also can be used to efficiently maneuver, separate and control ocular tissues.
There are no known contraindications to the use of the HEALON GV® OVD when used as recommended.
Precautions normally considered during ophthalmic surgical procedures should be taken. Postoperative intraocular pressure may be increased if the HEALON GV® OVD is left in the eye. Due to the greater viscosity of the HEALON GV® OVD, this increase in postoperative IOP may be higher than that caused by leaving the same amount of other sodium hyaluronate viscoelastic products, with lower zero shear viscosity, in the anterior chamber. Since rises in postoperative intraocular pressure, including cases of significant elevation and subsequent complications, have been reported, the following precautions are strongly recommended: Special care should be taken to ensure as complete removal as possible by continuing to irrigate/aspirate after you see displacement of the initial bolus of viscoelastic from the eye, continued irrigation/aspiration should facilitate removal of viscoelastic which may remain in the anterior segment. Pre-existing glaucoma, other causes of compromised outflow, higher preoperative intraocular pressure and complications in surgical procedures also may lead to increased intraocular pressure, consequently, extra care should be taken in patients with these conditions. Carefully monitor intraocular pressure, particularly during the early postoperative period. Treat with appropriate intraocular pressure lowering therapy, if required. The HEALON GV® OVD is a highly purified fraction extracted from avian tissues which may contain minute amounts of protein. The potential risks associated with the injection of biological material should be considered. Express a small amount of the HEALON GV® OVD from the syringe prior to use and carefully examine it during use to avoid injecting minute rubber particles which may be released when the syringe diaphragm is punctured. Sodium hyaluronate solution may appear cloudy or form precipitates when it is injected. Based on in vitro laboratory studies, this phenomenon may be related to interactions with concomitantly used ophthalmic medications or detergents which remain in reused cannulas. Reprocessed cannulas should not be used. Sporadic reports have been received indicating that the HEALON® OVD may become ”cloudy” or form a slight precipitate following instillation into the eye. The clinical significance of these reports, if any, is not known since the majority received to date do not indicate any harmful effects on ocular tissues. The physician should be aware of this phenomenon and, should it be observed, remove the cloudy or precipitated material by irrigation and/or aspiration. In vitro laboratory studies suggest that this phenomenon may be related to interactions with certain concomitantly administered ophthalmic medications. Use only if solution is clear.
Increased intraocular pressure has been reported after use of the HEALON GV® OVD. Increased intraocular pressure is likely to occur if the HEALON GV® OVD is not removed as completely as possible. Clinical judgement concerning the use of this product should be considered in cases where thorough removal may not be possible. The Precautions noted above should be taken to manage any increased postoperative intraocular pressure and to reduce the likelihood of occurrence of related postoperative complications such as optic neuropathy, pupillary atonia and dilation, and iris atrophy. Rarely, postoperative inflammatory reactions (iritis, hypopyon, endophthalmitis) following the use of sodium hyaluronate, as well as incidents of corneal edema and corneal decompensation, have been reported. Their relationship to sodium hyaluronate has not been established.
Reference the Directions for Use for a complete listing of indications, warnings, and precautions.