iStent infinite® IMPORTANT SAFETY INFORMATION

INDICATION FOR USE. The iStent infinite® System is intended to reduce intraocular pressure safely and effectively in adult patients diagnosed with primary open-angle glaucoma, pseudo-exfoliative glaucoma or pigmentary glaucoma. The device is safe and effective when implanted in combination with or without cataract surgery in those subjects who require intraocular pressure reduction and/or would benefit from glaucoma medication reduction. The device may also be implanted in patients who continue to have elevated intraocular pressure despite prior treatment with glaucoma medications and/or conventional glaucoma surgery. CONTRAINDICATIONS: The iStent infinite® System is contraindicated under the following circumstances or conditions: •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.• In patients with retrobulbar tumor, thyroid eye disease, Sturge-Weber Syndrome or any other type of condi-tion that may cause elevated episcleral venous pressure WARNINGS/PRECAUTIONS: • For prescription use only. • Intended users are trained ophthalmologists only. • This device has not been studied in patients with uveitic glaucoma. • Do not use the device if the Tyvek® lid has been opened or the packaging appears damaged. In such cases, the sterility of the device may be compromised. • Due to the sharpness of certain injector components (i.e., the insertion sleeve and trocar), care should be exercised to grasp the injector body. Dispose of device in a sharps container. • iStent infinite is MR-Conditional • Physician training is re-quired prior to use of the iStent infinite® System. • Do not re-use the stent(s) or injector, as this may result in infection and/or intraocular inflammation, as well as occurrence of potential postoperative adverse events • There are no known compatibility issues with the iStent infinite® and other intraoperative devices (e.g., viscoelastics) or glaucoma medications. • Unused product & packaging may be disposed of in accord-ance with facility procedures. Implanted medical devices and contaminated products must be disposed of as medical waste. • The surgeon should monitor the patient postoperatively for proper maintenance of intraocular pressure. If intraocular pressure is not adequately maintained after surgery, the surgeon should consider an appropriate treatment regimen to reduce in traocular pressure. • Patients should be informed that placement of the stents, without concomitant cataract surgery in phakic patients can enhance the formation or progression of cataract. ADVERSE EVENTS: The most common postoperative adverse events reported in the iStent infinite® pivotal trial included IOP increase ≥ 10 mmHg vs. baseline IOP (8.2%), loss of BSCVA ≥ 2 lines (11.5%), ocular surface disease (11.5%), perioperative inflammation (6.6%) and visual field loss ≥ 2.5 dB (6.6%). CAUTION: Please see DFU for a complete list of contraindications, warnings, precautions, and adverse events.