HEALON^™ Family of OVDs

REFERENCES
1. HEALON^™ PRO Cohesive OVD [package insert]. Irvine, CA: Johnson & Johnson Surgical Vision, Inc.
2. HEALON EndoCoat^™ Dispersive OVD [package insert]. Irvine, CA: Johnson & Johnson Surgical Vision, Inc.
3. HEALON^™ GV PRO Cohesive OVD [package insert]. Irvine, CA: Johnson & Johnson Surgical Vision, Inc.
4. HEALON5^™ PRO Viscoadaptive OVD [package insert]. Irvine, CA: Johnson & Johnson Surgical Vision, Inc.

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

Rx Only

INDICATIONS for HEALON EndoCoat^™ OVD: HEALON EndoCoat 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 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 OVD delivery system is not designed or intended to be attached to instruments other than the one provided with the product, as it may cause cannula detachment. When using HEALON EndoCoat OVD for surgery, the eye should not be irrigated with any solution containing benzalkonium chloride, because the mixing of quaternary ammonium salts, such as benzalkonium chloride, with sodium hyaluronate results in the formation of a precipitate.

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 HEALON 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 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. Product and cannula are for single use only. Re-use may cause eye inflammation. Express a small amount of the HEALON OVDs 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. 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. Overfilling the anterior or posterior segment of the eye with the HEALON^™ PRO OVD, may cause increased intraocular pressure, glaucoma, or other ocular damage. 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 as described in the HEALON OVDs Directions for Use. HEALON PRO OVD, HEALON GV PRO OVD and HEALON5 PRO OVD are a highly purified fraction extracted from microbial fermentation which may contain minute amounts of protein. The physician should be aware of the potential allergic risks such as postoperative inflammation that can occur with injection of biological materials.

PRECAUTIONS for HEALON EndoCoat OVD: Injection of the HEALON EndoCoat 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. HEALON EndoCoat OVD does not require refrigeration. If refrigerated, HEALON EndoCoat OVD should be allowed to attain room temperature prior to use.

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, the following 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. The following removal technique (Behind the Lens or TCT) is one option to ensure removal of the Healon GV PRO OVD. Use a standard I/A tip, 0.3 mm, with effectual flow of 20-25 ml/min and vacuum of 250-300 mmHg with a potential maximum setting at 500 mmHg. When using a machine with a peristaltic pump, use the upper limits of the suggested settings. When using a Venturi pump use the lower limits of the suggested settings. Bottle height should be 60-70 cm above eye level. Start the removal directly after the IOL implantation, while the anterior chamber is still filled with the HEALON GV PRO OVD and before the IOL has been centered. Go behind the IOL optic without engaging the flow of the I/A tip (port up) and then start flow. Remove the HEALON GV PRO OVD from the capsular bag first and ensure that the lens has adequately centered. While maintaining continuous flow remove the tip from behind the optic and place it on top of the optic. Continue the removal by circling the I/A tip at the iris plane, or on the optic surface, then make an additional sweep in the anterior chamber paying particular attention to the angles. HEALON GV PRO OVD may also be removed by creating maximum turbulence to make the HEALON GV PRO OVD fracture into large pieces. This can be accomplished by using the Rock’n Roll technique (described below) with standard I/A tip, 0.3 mm, with high settings, flow rates should be 25-30 ml/min and vacuum 350-500 mmHg, depending on the type of pump. If a peristaltic pump is used, the vacuum should be set towards the higher limit. If a Venturi pump is used, the vacuum should be set towards the lower limit. Bottle height should be 60-70 cm above eye level. For phacoemulsification machines that use linear foot pedal control, the suggested settings can only be achieved if the surgeon operates the phacoemulsification machine with fully depressed foot pedal. Settings will vary according to user preference for different types of programmable foot pedals. Start by circling the hand piece in the anterior segment at iris plane. Gently rest the I/A piece on the anterior surface of the optic. Press on the IOL optic on one side and rotate the I/A hand piece directing the flow into the bag. Direct the hand piece port towards the equator of the capsular bag and stay in this position for a few seconds and then repeat on the other side of the IOL optic until the HEALON GV PRO OVD is completely removed. Finally, sweep the anterior chamber including the angles. Note: The above phacoemulsification machine settings were used in a HEALON5 clinical study. Individual phacoemulsification system parameters vary. Although phacoemulsification machine settings may need to be altered due to differences in phacoemulsification machine technology, only the machine settings that redescribed above were shown to be effective at removing HEALON5 OVD in a clinical study. The safety and effectiveness of other phacoemulsification machine settings have not been demonstrated in a clinical study.

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 study, ninety-two percent of the adverse events were IOP >30 mmHg; incidence of IOP >30 mmHg occurred at a rate of 10.5%. One subject in the HEALON EndoCoat OVD group developed cystoid macular edema (CME) requiring treatment. This event was not considered by the investigators to be related to the viscoelastic used.

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

PP2023MLT6615