HEALON^™ Family of OVDs

REFERENCES

1. HEALON^™ PRO Cohesive OVD [package insert]. Irvine, CA: Johnson & Johnson Surgical Vision, Inc.

2. Hutz WW. Eckhardt B, Kohnen T. Comparison of viscoelastic substances used in phacoemulsification. J Cataract Refract Surg. 1996:22:955-959

3. HEALON EndoCoat^™ PRO Dispersive OVD [package insert]. Irvine, CA: Johnson & Johnson Surgical Vision, Inc.

4. Bissen-Miyajima H. In vitro behavior of ophthalmic viscosurgical devices during phacoemulsification. J Cataract Refract Surg. 2006:32;1026-1031.

5. Data on File. DOF2016CT0020 - HEALON^™ PRO and HEALON5^™ PRO

6. HEALON GV^™ PRO Cohesive OVD [package insert]. Irvine, CA: Johnson & Johnson Surgical Vision, Inc.

7. Holmen, Jorgen B. Scheimpflug photography study of ophthalmic viscosurgical devices during simulated cataract surgery. J Cataract Refract Surg 2003:29(3)568-574.

8. Holzer MP, et al. 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.

9. Tetz MR, et al. Clinical results of phacoemulsification with the use of HEALON5^™ or Viscoat^® J Cataract Refract Surg 2001: 27(3):416-420.

10. Data on File. REF2018CT4343 - Evaluation of the rheological properties of HEALON GV^™ PRO OVD

11. Data on File. DOF2018CT0001 - Clinical investigation of the bacterially-derived HEALON5^™

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR HEALON^™ FAMILY OF PRODUCTS

Rx Only

INDICATIONS for HEALON EdoCoat^™ PRO OVD: HEALON EndoCoat^™ PRO OVD is an ophthalmic viscoelastic containing 3% sodium hyaluronate indicated for use as a surgical aid in patients undergoing ophthalmic anterior segment procedures including: Cataract surgery with an intraocular lens, Cataract surgery without an intraocular lens, Secondary intraocular lens implantation. HEALON EndoCoat^™ PRO OVD maintains a deep chamber during anterior segment surgery, aids in tissue manipulation during surgery, enhances visualization during the surgical procedure and protects the corneal endothelium and other ocular tissue. The viscoelasticity of the solution maintains the normal position of the vitreous face and prevents formation of a flat chamber during surgery. It may also be used to coat intraocular lenses and insertion instruments prior to intraocular lens implantation.

INDICATIONS for HEALON^™ PRO OVD: The HEALON^™ PRO 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^™ PRO 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^™ PRO OVD serves as a surgical aid to gently separate, maneuver and hold tissues. The HEALON^™ PRO OVD creates a clear field of vision thereby facilitating intra- and post-operative inspection of the retina and photocoagulation.

INDICATIONS for HEALON GV^™ PRO OVD: The HEALON GV^™ PRO OVD is intended for use in anterior segment ophthalmic surgical procedures of the human eye. The HEALON GV^™ PRO 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 HEALON GV^™ PRO OVD can also be used to efficiently separate and control ocular tissues. The HEALON GV^™ PRO OVD is not designed to have any pharmacological effect.

INDICATIONS for HEALON5^™ PRO OVD: The HEALON5^™ PRO Ophthalmic Viscoelastic Device (OVD) is intended for use in anterior segment ophthalmic surgical procedures of the human eye. The HEALON5^™ PRO 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^™ PRO OVD can also be used to efficiently separate and control ocular tissues. The HEALON5^™ PRO OVD is not designed to have any pharmacological effect.

CONTRAINDICATIONS: There are no known contraindications to the use of HEALON^™ Family of OVDs when used as recommended.

WARNINGS: HEALON GV^™ PRO OVD is difficult to remove from the eye. It is a high-viscosity cohesive OVD that displays dispersive behavior during removal. This behavior during removal is different compared to the similarly named HEALON GV^™ OVD. Adequate removal of HEALON GV^™ PRO OVD may require the specific surgical removal techniques described below. Users should weigh the potential benefit/risk ratio of using this device based on their own personal skill and comfort level with the recommended surgical removal techniques.

The HEALON EndoCoat^™ PRO OVD Delivery system is not designed or intended to be attached to instruments other than the one provided with the product. Failure to follow the “Directions for Use” may result in cannula detachment. Mixing of quaternary ammonium salts, such as benzalkonium chloride, with sodium hyaluronate solutions results in the formation of a precipitate. The eye should not be irrigated with any solution containing benzalkonium chloride if HEALON EndoCoat^™ PRO OVD is to be used during surgery. Increased intraocular pressure is likely to occur if the HEALON EndoCoat^™ PRO OVD is not removed as completely as possible or if insufficient time is spent removing the OVD from the eye. Clinical judgement concerning the use of this product should be considered in cases where thorough removal may not be possible.

PRECAUTIONS FOR THE HEALON^™ FAMILY OF PRODUCTS: The OVD may appear cloudy or form precipitates when it is injected. Should it be observed, remove the cloudy or precipitated material by irrigation and/or aspiration. Use only if the OVD solution is clear. Postoperative intraocular pressure (IOP) may be increased if the HEALON^™ OVDs are left in the eye. The potential for early and short-term post-operative IOP spikes exists with HEALON^™ OVDs (refers to HEALON^™ PRO, HEALON5^™ PRO, HEALON EndoCoat^™ PRO and HEALON GV^™ PRO OVDs), that require time and care to remove from the eye. Therefore, it is recommended that the HEALON^™ OVDs be removed from the eye completely by irrigating and aspirating with sterile irrigation solution to reduce the risk of early postoperative IOP spikes. Special care should be taken to ensure complete removal of the HEALON GV^™ PRO and HEALON5^™ PRO OVD from the entire eye including behind the lens and the chamber angles to avoid intraocular pressure peaks postoperatively. Due to the greater viscosity of the HEALON GV^™ PRO and HEALON5^™ PRO 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. Postoperative intraocular pressure may also be elevated as a result of preexisting 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. Do not overfill the eye chambers with the HEALON^™ OVDs, completely remove the HEALON^™ OVDs by irrigation and/or aspiration at the close of the surgery and carefully monitor intraocular pressure, particularly during the early postoperative period. Treat with appropriate intraocular pressure lowering therapy, if required.

PRECAUTIONS for HEALON EndoCoat^™ PRO OVD: Injection of the HEALON EndoCoat^™ PRO OVD creates pressure in the syringe. To prevent expulsion of the cannula into the eye, ensure that the cannula is securely attached to the fitting on the syringe. Use of the cannula guard is recommended. Extrusion of a test droplet is recommended prior to entering the eye, and excessive force on the plunger should be avoided.  

PRECAUTIONS for HEALON GV^™ PRO OVD: As a result of non-clinical and clinical experience, during removal, HEALON GV^™ PRO OVD performs similarly to HEALON5^™ and HEALON5^™ PRO OVDs, two high-viscosity OVDs that are more difficult to remove from the eye compared to typical cohesive OVDs. Two surgical removal techniques were previously studied with the original HEALON5^™ OVD and were shown to be effective at removing HEALON5^™ OVD from the eye; The Behind the Lens or the Two-Compartment Technique (TCT) was superior to the Rock'n Roll technique with regards to IOP elevation in a clinical study. Since HEALON GV^™ PRO OVD performs similarly to HEALON5^™ OVD during OVD removal, these two surgical techniques are recommended to remove HEALON GV^™ PRO OVD from the eye. The safety and effectiveness of other removal techniques have not been demonstrated in a clinical study. See the Healon GV PRO Directions for Use for a description of the Two-Compartment Technique (TCT) and Rock’n Roll Technique.

SERIOUS ADVERSE EVENTS: The most frequently reported serious adverse events that occurred during the clinical trial of the HEALON5^™ PRO were intraocular pressure (IOP) spikes ≥30 mmHg (18 eyes, 8.5 %) and surgical reintervention (AC Taps to treat the elevated IOP, 7 eyes, 3.3 %). 

In the HEALON EndoCoat^™ PRO study, elevated intraocular pressure ≥30 mmHg occurred at a rate of 8.4%, cystoid macular edema (CME) occurred at a rate of 1.5% and central serous retinopathy occurred at rate of 0.8% in the HEALON EndoCoat^™ PRO OVD group.

ATTENTION: Reference the Directions for Use for a complete listing of Important Indications and Safety Information.