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Important Safety Information – HEALON GV® Ophthalmic Viscoelastic Device (OVD)

Caution: Federal law restricts this device to sale by or on the order of a physician.

Indications: 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.

Precautions: 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:

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.

Adverse Events: 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.

Attention: Reference the Directions for Use for a complete listing of indications, warnings, and precautions.