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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.

HEALON5<sup>®</sup> OVD

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.

healon5 chart 1

Product information per respective product insert. Viscosity measurements vary per methods reported in respective product package insert.

  • Unique dual-property viscoadaptive-behaves like a cohesive and a dispersive agent
  • Designed to maximize control throughout surgery
  • Helps provide excellent control during capsulorrhexis,3 phacoemulsification,4 and lens placement5,7
  • Outstanding endothelial protection7
  • Latex free

Remarkable dual-property viscoadaptive

  • Allows surgeons to control its behavior by adjusting aspiration flow rates
  • Possesses the highest zero shear viscosity of any viscoelastic (7,000,000 mPas)
  • Acts like a cohesive agent at low flow rates to maintain the anterior chamber
  • Acts like a dispersive agent at high flow rates to protect endothelial cells during phaco
healon5 chart 2
**Allervisc is a trademark of Allergan, Inc.; Provisc is a trademark of Novartis International AG;

Designed to bring greater control during Phacoemulsification

  • Remains in the anterior chamber during phacoemulsification for exceptional control of the intraocular environment5,6
  • Separates tissues for enhanced maneuverability5,6

Enhances control during lens placement

  • Offsets positive pressure5,7
  • Maintains inflation of the capsular bag throughout lens implantation5,7
  • Designed to minimize the risk of developing a shallow anterior chamber

healon5 chart 3

Delivers outstanding protection every step of the way

  • Provides greater endothelial cell protection than the dispersive agent5 VISCOAT® and Ocucoat® OVD5
  • Separates tissues during phacoemulsification for added protection5,6
  • Cushions delicate iris tissue and helps reduce the risk of iris prolapse4,5
  • Helps control unfolding of the intraocular lens4,5

healon5 chart 4
** Ocucoat is a trademark of Bausch & Lomb Inc.

References

References

1. Hütz WW, Eckhardt HB, Kohnen T. Comparison of viscoelastic substances used in phacoemulsification. J Cataract Refract Surg. 1996;22(11):955-959.
2. Buratto L, Giardini P, Bellucci R. Viscoelastics In Ophthalmic Surgery. Thorofare, NJ: Slack Inc; 2005:5.
3. Holmen J JB, Lundgren B. Scheimpflug photography study of ophthalmic viscosurgical devices during simulated cataract surgery. J Cataract Refract Surg. 2003;29(3):568-574.
4. Claesson M. A comparative study between Healon5 and Viscoat. Paper presented at: The XVI Congress of the European Society of Cataract and Refractive Surgeons (ESCRS);September 1998; Nice, France.
5. Tetz M. Protective study on endothelial cell protection with the use of different viscoelastic agents including Healon5. Paper presented at: The XVI Congress of the European Society of Cataract and Refractive Surgeons (ESCRS); September 1998; Nice, France.
6. Arshinoff S. Viscous-retentive ophthalmic viscoelastics. Paper presented at: The XVI Congress of the European Society of Cataract and Refractive Surgeons (ESCRS);September 1998; Nice, France.
7. Holzer MP, Tetz MR, Auffarth GU,Welt R, Volcker HE. Effect of Healon5 and 4 other viscoelastic substances on intraocular pressure and endothelium after cataract surgery. J Cataract Refract Surg.2001;27(2):213-218.

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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.



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