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HEALON GV® PRO Ophthalmic Viscoelastic Device

HEALON GV® PRO Ophthalmic Viscoelastic Device

 

Easy space creation to help you apply the finishing touch to procedures 

When maximum chamber maintenance is needed, HEALON GV® PRO cohesive* OVD:

  • Facilitates capsulorhexis by helping maintain a deep anterior chamber1,2
  • Supports safe and controlled manipulation inside the eye with reduced trauma to the corneal endothelium1
  • Creates and sustains a clear field of vision during surgery1,2

 

*Healon GV PRO OVD is a high viscosity cohesive that displays dispersive behavior during removal.​

HEALON GV® PRO OVD

Classification

Cohesive*

Full Size

0.85 mL

Molecular Wight

3,200,000 Da

Viscosity

2,000,000 mPas

*Healon GV® PRO OVD is a high viscosity cohesive that displays dispersive behavior during removal

REFERENCES

1. HEALON® GV PRO Cohesive OVD [package insert]. Santa Ana, CA: Johnson & Johnson Surgical Vision, Inc.
2. Data on File - Evaluation of the rheological properties of Healon GV PRO OVD.
 

INDICATIONS AND IMPORTANT SAFETY INFORMATION for HEALON GV® PRO Ophthalmic Viscoelastic Device (OVD)

Rx Only

INDICATIONS

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.

CONTRAINDICATIONS

There are no known contraindications to the use of the HEALON GV® PRO OVD 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.

PRECAUTIONS

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 are described 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. A transient myopic shift may also occur if the HEALON GV® PRO OVD is not completely removed from the capsular bag behind the intraocular lens. Postoperative intraocular pressure (IOP) may be increased if the HEALON GV® PRO OVD is left in the eye. Special care should be taken to ensure complete removal of the HEALON GV® PRO OVD from the entire eye including behind the lens and the chamber angles. Continued irrigation/aspiration after displacement of the initial bolus of viscoelastic from the eye should facilitate removal of viscoelastic if remaining in the anterior segment; additional surgical maneuvers are likely needed to remove OVD that is trapped behind the lens. Due to the greater viscosity of the HEALON GV® PRO OVD, 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. Since rises in postoperative pressure, including cases of significant elevation and rare incidents of complications (including ischemic optic neuropathy, retinal vascular occlusion, corneal edema, increased light sensitivity/photophobia, swelling of capsular bag, unexpected post-operative refraction, pain, nausea, post-operative iris constriction and loss of vision in glaucoma patients), have been reported, the following precautions are strongly recommended. Postoperative IOP may be elevated as a result of pre-existing glaucoma, other causes of compromised outflow, higher preoperative intraocular pressure and complications in surgical procedures may also lead to increased intraocular pressure. The following precautions are recommended: do not overfill the eye chambers with the HEALON GV® PRO OVD, completely remove the HEALON GV® PRO OVD by irrigation and/or aspiration at the close of the surgery and carefully monitor intraocular pressure, especially during the immediate postoperative period. Treat with appropriate intraocular pressure lowering therapy, if required. Prophylactic pressure lowering treatment should always be considered. The potential for early and short-term post-operative IOP spikes exists with cohesive OVDs, that require time and care to remove from the eye. Therefore, it is recommended that HEALON GV® PRO OVD be removed from the eye completely by irrigating and aspirating with sterile irrigation solution to reduce the risk of early postoperative IOP spikes. Overfilling the anterior segment of the eye with the HEALON GV® PRO OVD may cause increased intraocular pressure, glaucoma, or other ocular damage. Using higher molecular weight, high concentration viscoelastics, such as HEALON GV® PRO OVD, may impede aspiration and/or potentially lead to blockage of aspiration flow through phaco tubing, especially when reuse of aspiration tubing, use of multiple vials of viscoelastics and/or lens fragments are combined. Carefully examine the HEALON GV® PRO OVD as it is injected and during use to avoid injecting minute rubber particles which may be released when the syringe diaphragm is punctured. Product and cannula are for single use only. Re-use may cause eye inflammation.

ADVERSE REACTIONS

Increased intraocular pressure has been reported after use of the HEALON GV® PRO OVD. Increased intraocular pressure is likely to occur if the HEALON GV® PRO OVD is not removed as completely as possible. Clinical judgement concerning the use of this product should be considered in cases where thorough removal may not be possible. Any increase in postoperative intraocular pressure should be managed 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. 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® PRO OVD.

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%.

ATTENTION

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

PP2021CT4213