Important Safety Information

iStent inject^® W Important Safety Information

INDICATION FOR USE

The iStent inject^® W Trabecular Micro-Bypass System (Model G2-W) is intended to reduce intraocular pressure in adult patients diagnosed with mild to moderate primary open-angle glaucoma (POAG) currently treated with ocular hypotensive medication. The device can be implanted with or without cataract surgery.

CONTRAINDICATIONS

The device is contraindicated for use in eyes with primary angle closure glaucoma, or secondary angle-closure glaucoma, including neovascular glaucoma, because the device would not be expected to work in such situations, and in patients with retrobulbar tumor, thyroid eye disease, Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure.

WARNINGS

This device has not been studied in patients with uveitic glaucoma. Patients should be informed that placement of the stents, without concomitant cataract surgery in phakic patients, can enhance the formation or progression of cataract. The surgeon should monitor the patient postoperatively for proper maintenance of intraocular pressure. iStent inject^® is MR-Conditional, meaning that the device is safe for use in a specified MRI environment under specified conditions; please see labelling for details. Physician training is required prior to use. Do not re-use the stent(s) or injector.

ADVERSE EVENTS

Postoperative adverse events include but are not limited to: corneal complications including edema, opacification and decompensation, cataract formation (in phakic patients), posterior capsule opacification, stent obstruction, intraocular inflammation (non-pre existing), BCVA loss and IOP increase requiring management with oral or intravenous medications or surgical intervention. Please refer to Directions for Use for additional adverse event information.

CAUTION

Please reference the Directions For Use labelling for a complete list of contraindications, warnings and adverse events.

Important Safety Information »

iStent inject® W Important Safety Information