Important Safety Information

INDICATIONS FOR USE

The iStent inject® Trabecular Micro-Bypass System (Model G2-M-IS-AS) is indicated for use in conjunction with cataract surgery for the reduction of intraocular pressure (IOP) in adult patients with mild to moderate open-angle glaucoma currently treated with ocular hypotensive medication. The implant is designed to stent open a passage through the trabecular meshwork to allow for an increase in the facility of outflow and a subsequent reduction in intraocular pressure.

CONTRAINDICATIONS

The iStent inject® 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 condition that may cause elevated episcleral venous pressure

WARNINGS/PRECAUTIONS
  • For prescription use only.
  • This device has not been studied in patients with uveitic glaucoma.
  • Do not use the devices 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 inject® is MR-Conditional; see MRI Information below.
  • Physician training is required prior to use of the iStent inject® System, and consists of three main parts:
    • Webinar
    • Didactic session with Glaukos surgical representative
    • Observation of surgical cases by Glaukos representative until implantation proficiency is demonstrated
  • Do not re-use the stent(s) or inserter, as this may result in infection and/or intraocular inflammation, as well as occurrence of potential postoperative adverse events as shown below under “Potential Complications.”
  • There are no known compatibility issues with the iStent inject® and other intraoperative devices (e.g., viscoelastics) or glaucoma medications.
  • Unused product & packaging may be disposed of in accordance 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 intraocular pressure.