INDICATIONS AND IMPORTANT SAFETY INFORMATION for HEALON5® PRO Ophthalmic Viscoelastic Device (OVD)
The HEALON5® PRO 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.
There are no known contraindications to the use of the HEALON5® PRO OVD when used as recommended.
Precautions normally considered during ophthalmic surgical procedures should be taken. Special care should be taken to ensure complete removal of the HEALON5® PRO OVD from the entire eye including behind the lens and the chamber angles. Complete removal of the HEALON5® PRO OVD is important to avoid intraocular pressure peaks postoperatively. Due to the greater viscosity and higher concentration of sodium hyaluronate in the HEALON5® PRO OVD, the rise in the postoperative intraocular pressure may be higher with the HEALON5® PRO 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® PRO OVD has to be left in the eye for clinical reasons.
The HEALON5® PRO OVD is a highly purified fraction extracted from avian tissues or from fermented bacteria which may contain minute amounts of protein. Express a small amount of the HEALON5® PRO OVD 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. Sodium hyaluronate solution may appear cloudy or form precipitates when it is injected. In-vitro studies have shown incompatibility, resulting in opalescence, between sodium hyaluronate and solutions containing cationic components, e.g., detergents and benzalkonium chloride. Reprocessed cannulas should not be used. Do not use if the blister package has been damaged. Do not resterilize. The potential for early and short-term post-operative intraocular pressure (IOP) spikes exists with dispersive OVDs, which potentially require more time and care to remove from the eye. Therefore, it is recommended that HEALON5® PRO OVD be removed from the eye completely by irrigating and aspirating with sterile irrigation solution to reduce the risk of early post-operative IOP spikes. Product and cannula are for single use only. Re-use may cause eye inflammation.
Increased intraocular pressure has been reported after use of sodium hyaluronate solutions. Increased intraocular pressure is likely to occur if the HEALON5® PRO 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 edema and corneal decompensation, have been reported. Their relationship to sodium hyaluronate has not been established.
SERIOUS ADVERSE EVENTS
HEALON5® PRO data is applicable to HEALON® PRO OVD. 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%). One eye was reported with keratitis secondary to Sjogren’s, one eye was reported with Mild TASS, and one eye was reported with proliferative diabetic retinopathy. No other serious adverse events occurred during the trial.
Reference the Directions for Use for a complete listing of Important Indications and Safety Information.