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

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

The HEALON® OVD is indicated for use as a surgical aid in cataract extraction (intra- and extracapsular), IOL implantation, corneal transplant, glaucoma filtration and retinal attachment surgery. In surgical procedures in the anterior segment of the eye, instillation of the HEALON® OVD serves to maintain a deep anterior chamber during surgery, allowing for efficient manipulation with less trauma to the corneal endothelium and other surrounding tissues. Furthermore, its viscoelasticity helps to push back the vitreous face and prevent formation of a postoperative flat chamber. In posterior segment surgery the HEALON® OVD serves as a surgical aid to gently separate, maneuver and hold tissues. The HEALON® OVD creates a clear field of vision thereby facilitating intra- and post-operative inspection of the retina and photocoagulation.

Those normally associated with the surgical procedure being performed. Overfilling the anterior or posterior segment of the eye with the HEALON® OVD may cause increased intraocular pressure, glaucoma, or other ocular damage. Postoperative intraocular pressure may also be elevated as a result of pre-existing glaucoma, compromised outflow and by operative procedures and sequelae thereto, including enzymatic zonulysis, absence of an iridectomy, trauma to filtration structures, and by blood and lenticular remnants in the anterior chamber. Since the exact role of these factors is difficult to predict in any individual case, the following precautions are recommended:

Care should be taken to avoid trapping air bubbles behind the HEALON® OVD. Because the HEALON® OVD is a highly purified fraction extracted from avian tissues and is known to contain minute amounts of protein, the physician should be aware of potential risks of the type that can occur with the injection of any biological material. Because of reports of an occasional release of minute rubber particles, presumably formed when the diaphragm is punctured, the physician should be aware of this potential problem. Express a small amount of the HEALON® OVD from the syringe prior to use, and carefully examine the remainder as it is injected. 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.

Adverse Events: The HEALON® OVD is extremely well tolerated after injection into human eyes. A transient rise of intraocular pressure postoperatively has been reported in some cases. In posterior segment surgery intraocular pressure rises have been reported in some patients, especially in aphakic diabetics, after injection of large amounts of the HEALON® OVD. Rarely, postoperative inflammatory reactions (iritis, hypopyon) as well as incidents of corneal edema and corneal decompensation have been reported. Their relationship to the HEALON® OVD has not been established.

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