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Important Safety Information – HEALON5® Ophthalmic Viscoelastic Device (OVD)

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

Indications: The HEALON5® OVD is intended for use in anterior segment ophthalmic surgical procedures of the human eye. The HEALON5® OVD is designed to create and maintain a deep anterior chamber which facilitates manipulation inside the eye with reduced trauma to the corneal endothelium and other ocular tissues. The HEALON5® OVD can also be used to efficiently separate and control ocular tissues. The HEALON5® OVD is not designed to have any pharmacological effect.

Precautions: Precautions normally considered during ophthalmic surgical procedures should be taken. Special care should be taken to ensure complete removal of the HEALON5® OVD from the entire eye including behind the lens and the chamber angles. Complete removal of the HEALON5® OVD is important to avoid intraocular pressure peaks postoperatively. Due to the greater viscosity and higher concentration of sodium hyaluronate in the HEALON5® OVD, the rise in the postoperative intraocular pressure may be higher with the HEALON5® OVD than if the same volume of other sodium hyaluronate viscoelastic products, with lower zero shear viscosity, is left in the anterior segment of the eye. Before initiating phacoemulsification, use irrigation/aspiration to create a fluid-filled space above the lens. This reduces the risk of initial visco-occlusion of the phaco tip or the irrigation line which could cause phaco tip heating. Pre-existing glaucoma, other causes of compromised outflow, higher preoperative intraocular pressure and complications in surgical procedures may also lead to increased intraocular pressure; consequently, extra care should be taken in patients with these conditions. Prophylactic pressure-lowering treatment should always be considered and especially in cases where the HEALON5® OVD has to be left in the eye for clinical reasons.

Adverse Events: Increased intraocular pressure has been reported after use of sodium hyaluronate solutions. Increased intraocular pressure is likely to occur if the HEALON5® OVD is not removed as completely as possible. Clinical judgment 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.

 

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

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

Indications:
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.

Precautions:
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:

  • Don't overfill the eye chambers with the HEALON® OVD (except in glaucoma surgery).
  • In posterior segment procedures in aphakic diabetic patients special care should be exercised to avoid using large amounts of the HEALON® OVD.
  • Remove some of the HEALON® OVD by irrigation and/or aspiration at the close of surgery (except in glaucoma surgery).
  • Carefully monitor the intraocular pressure, especially during the immediate postoperative period. If significant rises are observed, treat with appropriate therapy.

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.

HEALON<sup>®</sup> Ultimate Dual Pack

HEALON® and HEALON5® OVDs are used in ophthalmic surgical procedures to maintain deep anterior chamber, which facilitates manipulation inside the eye with reduced trauma to the corneal endothelium and other ocular tissues.

Product Size Viscosity Molecular Weight Composition Classification
HEALON® OVD 0.55 mL 300,000 mPas 4,000,000 daltons 1.0% NaHA Cohesive
HEALON5® OVD 0.60 mL 7,000,000 mPas 4,000,000 daltons 2.3% NaHA Viscoadaptive

From beginning to end, the HEALON® and HEALON5® OVD Combination scores on protection and control

HEALON® and HEALON5® OVDs offer unique properties that work together as a team to give surgeons the ultimate in protection, control, clarity, and ease-of-use for every cataract procedure. The combination allows for ideal OVD utilization during each phase of surgery, regardless of surgeons' preferred techniques.

The Cataract Play by Play

  • HEALON5® OVD flattens the anterior capsule to help create a smooth, intact capsulorhexis
  • HEALON5® OVD delivers endothelial cell protection by compartmentalizing the anterior chamber to protect the cornea from turbulence during phacoemulsification
  • HEALON® OVD maintains a deep anterior chamber under pressure for improved insertion, maneuvering, and unfolding of the IOL
  • HEALON® OVD offers high cohesiveness for easy removal at the end of the procedure

Important Safety Information – HEALON5® Ophthalmic Viscoelastic Device (OVD)

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

Indications: The HEALON5® OVD is intended for use in anterior segment ophthalmic surgical procedures of the human eye. The HEALON5® OVD is designed to create and maintain a deep anterior chamber which facilitates manipulation inside the eye with reduced trauma to the corneal endothelium and other ocular tissues. The HEALON5® OVD can also be used to efficiently separate and control ocular tissues. The HEALON5® OVD is not designed to have any pharmacological effect.

Precautions: Precautions normally considered during ophthalmic surgical procedures should be taken. Special care should be taken to ensure complete removal of the HEALON5® OVD from the entire eye including behind the lens and the chamber angles. Complete removal of the HEALON5® OVD is important to avoid intraocular pressure peaks postoperatively. Due to the greater viscosity and higher concentration of sodium hyaluronate in the HEALON5® OVD, the rise in the postoperative intraocular pressure may be higher with the HEALON5® OVD than if the same volume of other sodium hyaluronate viscoelastic products, with lower zero shear viscosity, is left in the anterior segment of the eye. Before initiating phacoemulsification, use irrigation/aspiration to create a fluid-filled space above the lens. This reduces the risk of initial visco-occlusion of the phaco tip or the irrigation line which could cause phaco tip heating. Pre-existing glaucoma, other causes of compromised outflow, higher preoperative intraocular pressure and complications in surgical procedures may also lead to increased intraocular pressure; consequently, extra care should be taken in patients with these conditions. Prophylactic pressure-lowering treatment should always be considered and especially in cases where the HEALON5® OVD has to be left in the eye for clinical reasons.

Adverse Events: Increased intraocular pressure has been reported after use of sodium hyaluronate solutions. Increased intraocular pressure is likely to occur if the HEALON5® OVD is not removed as completely as possible. Clinical judgment 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.

 

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

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

Indications:
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.

Precautions:
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:

  • Don't overfill the eye chambers with the HEALON® OVD (except in glaucoma surgery).
  • In posterior segment procedures in aphakic diabetic patients special care should be exercised to avoid using large amounts of the HEALON® OVD.
  • Remove some of the HEALON® OVD by irrigation and/or aspiration at the close of surgery (except in glaucoma surgery).
  • Carefully monitor the intraocular pressure, especially during the immediate postoperative period. If significant rises are observed, treat with appropriate therapy.

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.



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