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

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INDICATIONS

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.

CONTRAINDICATIONS

At present there are no known contraindications to the use of the  HEALON^® PRO OVD when used as recommended.

PRECAUTIONS

Those normally associated with the surgical procedure being performed. Overfilling the anterior or posterior segment of the eye with the HEALON^® PRO OVD may cause increased intraocular pressure, glaucoma, or other ocular damage. 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. Since the exact role of these factors is difficult to predict in any individual case, the following precautions are recommended:

• Don’t overfill the eye chambers with the HEALON^® PRO OVD (except in glaucoma surgery - See Applications section in Directions for Use.
• In posterior segment procedures in aphakic diabetic patients special care should be exercised to avoid using large amounts of the HEALON^® PRO OVD.
• Remove some of the HEALON^® PRO OVD by irrigation and/or aspiration at the close of surgery (except in glaucoma surgery - See Applications section.
• Carefully monitor the intraocular pressure, especially during the immediate postoperative period. If significant rises are observed, treat with appropriate therapy.

Care should be taken to avoid trapping air bubbles behind the HEALON^® PRO OVD. Because of reports of an occasional release of minute rubber particles, presumably formed when the diaphragm is punctured, the physician should be aware of this potential problem. Express a small amount of the HEALON^® PRO OVD from the syringe prior to use, and carefully examine the remainder as it is injected. Reprocessed cannulas should not be used. Sporadic reports have been received indicating that the HEALON^® OVD may become ”cloudy” or form a slight precipitate following instillation into the eye. The clinical significance of these reports, if any, is not known since the majority received to date does not indicate any harmful effects on ocular tissues. The physician should be aware of this phenomenon and, should it be observed, remove the cloudy or precipitated material by irrigation and/or aspiration. In vitro laboratory studies suggest that this phenomenon may be related to interactions with certain concomitantly administered ophthalmic medications. Use only if solution is clear. Product and cannula are for single use only. Re-use may cause eye inflammation. 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 HEALON^® 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. Do not use if the blister pack has been damaged.

ADVERSE REACTIONS

The HEALON^® PRO OVD is extremely well tolerated after injection into human eyes. 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. Rarely, postoperative inflammatory reactions (iritis, hypopyon) as well as incidents of corneal edema and corneal decompensation have been reported. Their relationship to the HEALON^® PRO OVD has not been established.

SERIOUS ADVERSE EVENTS

HEALON5^® PRO OVD 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.

ATTENTION

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

PP2021CT4046