AUP-000128 Rev 1 03/24

3) Use cohesive viscoelastic to inflate the anterior chamber tocreate access to the stent’s location, move the stent away from adelicate structure if loose, and/or protect intraocular tissues.
4) Use a gonioscope if needed to visualize the location of the stentin the anterior chamber.
5) Insert a micro forceps device through the corneal incision andgrasp the stent in a convenient and secure manner before
removing the stent from the anterior chamber.
6) Irrigate the anterior chamber with balanced salt solution (BSS)
through the corneal wound to remove all viscoelastic. Press
down on the posterior edge of the incision as needed to facilitate
complete removal of viscoelastic. Repeat as needed until allviscoelastic has been removed.
7) Inflate the anterior chamber with saline solution as needed toachieve normal physiologic pressure.
8) Ensure that the corneal incision is sealed.

iStent infinite® Trabecular Micro-Bypass System

INSTRUCTIONS FOR USE
DEVICE DESCRIPTION
Catalogue #iS3

Description
Glaukos® iStent infinite® System Model iS3
with three (3) G2-W stearalkonium heparincoated Trabecular Micro-Bypass Stents
preloaded in one injector

The iStent infinite® System contains three intraocular stents that are
manufactured from implant grade titanium (Ti6Al4V ELI) and arecoated with stearalkonium heparin (note: the heparin is from a porcine
source). The stent has a single piece design, is approximately 360
microns in height and 360 microns in diameter. The injector has been
designed by Glaukos Corporation to implant three Model G2-W stents
through a single incision into Schlemm’s canal.
The implant is designed to stent open a passage through thetrabecular meshwork to allow for an increase in the facility of outflow
and a subsequent reduction in intraocular pressure.

HOW SUPPLIED
Each iStent infinite System is provided sterile in a blister tray (only theinner contents of the blister tray are sterile). Three stents are alreadyassembled onto the single-use injector. The blister tray lid is labeledwith the required product identification information. A lot number
and serial number are provided on the labeling. The iStent infinite
System is sterilized by gamma irradiation.
The expiration date on the device package (tray lid) is the sterility
expiration date. In addition, there is a sterility expiration date that isclearly indicated on the outside of the unit carton. Sterility is assured ifthe tray seal is not broken, punctured or damaged until the expiration
date. This device should not be used past the indicated sterility
expiration date.

WARNINGS/PRECAUTIONS
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INDICATIONS FOR USE
The iStent infinite Trabecular Micro-Bypass System Model iS3 isintended to reduce intraocular pressure in adult patients diagnosed
with primary open-angle glaucoma (POAG) currently treated withocular hypotensive medication. The device can be implanted with orwithout cataract surgery.

CONTRAINDICATIONS
The iStent infinite System is contraindicated under the following
circumstances or conditions:¶ In eyes with primary angle closure glaucoma, or secondary angleclosure glaucoma, including neovascular glaucoma, because thedevice would not be expected to work in such situations¶ In patients with retrobulbar tumor, thyroid eye disease, SturgeWeber Syndrome or any other type of condition that may cause
elevated episcleral venous pressure

INSTRUCTIONS FOR USE1) Remove the Stent Delivery Button Lock from the injector.
2) Make a corneal incision of adequate length to allow entry of
the introducer tip of the injector into the anterior chamber.
Recommended incision location is the temporal peripheral
cornea for either eye. Ophthalmic viscoelastic (cohesive) should
be used to form the anterior chamber, as necessary. Deepen theanterior chamber by injecting with viscoelastic as needed, being
careful not to overinflate.
3) The iStent infinite injector insertion steps are as follows: With
the gonioprism removed from the cornea, insert the injector
Introducer Tip through the clear corneal incision into the anteriorchamber. Once the Introducer Tip has been inserted throughthe corneal incision, the Introducer Tip auto-retracts exposing
the Insertion Tube and Trocar tip. Advance the Insertion Tube tothe pupillary margin toward the targeted trabecular meshwork
tissue (i.e., the ab interno approach). Take care to avoid contact
with the IOL, iris, or cornea.
4) Place the gonioprism on the cornea and position the patientand surgical microscope as needed to visualize the trabecularmeshwork through the gonioprism on the nasal side of the eye.
5) Advance the Insertion Tube containing the trocar towards the TM(just above the scleral spur) and penetrate the trocar tip throughthe center of the TM. The trocar is used to not only penetrate theTM, but will remain in the tissue to act as an axial guide for thestent as the stent traverses over the trocar through to Schlemm’scanal.
6) Gently hold the Insertion Tube against the TM and apply
appropriate pressure to slightly indent or “dimple” the tissue(tissue should stretch just enough to form a “V” when pressingon the TM).
7) Slowly squeeze and hold down the Stent Delivery Button toautomatically inject the stent head through the TM and into
Schlemm’s canal. Look through the window in the insertion tube
to verify that the stent has been implanted properly.
8) Withdraw the injector straight back from the stent, and verify
that the stent is well-positioned and secured in the TM.
9) Actuate the Singulator to prepare the next stent for implantation.
Listen for two audible clicks, and verify that the next stent isvisible in the window of the insertion tube.
10) Carefully relocate the tip of the injector approximately 2 clock
hours away from the first stent for implantation of the secondstent. Implant the next stent using the same procedure as theprevious stent.
11) Repeat the previous step for the third stent, placing the third
stent approximately 2 clock hours away from either of the firsttwo stents.
12) Remove the injector from the eye.
13) Irrigate the anterior chamber with balanced salt solution (BSS)
through the corneal wound to remove all viscoelastic. Press
down on the posterior edge of the incision as needed to facilitate
complete removal of viscoelastic.
14) Inflate the anterior chamber with saline solution as needed toachieve normal physiologic pressure.
15) Ensure that the corneal incision is sealed.
Retrieval of an Implanted Stent
1) Prep the patient as one would for stent implantation surgery.
2) Re-open the eye at the preferred location in order to reach thestent. A clear corneal incision measuring approximately 1.5mm
in length is recommended.

•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 thepackaging appears damaged. In such cases, the sterility of thedevice may be compromised.
Due to the sharpness of certain injector components (i.e. theinsertion sleeve and trocar), care should be exercised to grasp theinjector body. Dispose of device in a sharps container.
iStent infinite is MR-Conditional; see MRI Information below
Physician training is required prior to use of the iStent infiniteSystem.
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 as shown below under “PotentialComplications.”
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 accordancewith facility procedures. Implanted medical devices andcontaminated 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 notadequately maintained after surgery, the surgeon should consider
an appropriate treatment regimen to reduce intraocular pressure.
Patients should be informed that placement of the stents, without
concomitant cataract surgery in phakic patients can enhance theformation or progression of cataract.

Static magnetic field of 7-Tesla, ONLY:
Non-clinical testing demonstrated that the iStent infinite Trabecular
Micro-Bypass Stent, Model iS3 is MR Conditional.
A patient with this device can be safely scanned immediately after
implantation in an MR system meeting the following conditions:• Static magnetic field of 7T, ONLY
• Maximum spatial gradient magnetic field of• 10,000-gauss/cm (extrapolated) or less
• Maximum MR system reported, whole body averaged specificabsorption rate (SAR) of 4-W/kg for 15 minutes of scanning(i.e., per pulse sequence)• First Level Controlled Operating Mode of operation for the MRsystem• Use of a transmit/receive RF head coil, ONLY
MRI-Related Heating
In non-clinical testing, the device produced a temperature rise of0.4°C during MRI performed for 15-minutes of scanning (i.e., per pulsesequence) in a 7-Tesla/298-MHz MR system (Philips Acheiva, Philips
Healthcare, Cleveland, OH) using at transmit/receive RF head coil.
MR system reported, whole body averaged: SAR < 1-W/kg.
Artifact Information
In non-clinical testing, the image artifact caused by the device
extends approximately 23-mm from this device when imaged using a
gradient echo pulse sequence and a 7T MR system

LABELING

The following symbols are used on the device packaging.
SymbolCatalogue/Model Number
Serial Number (for the stent)
Lot Number
Do not reuseyyyy-mm-dd

STORAGE REQUIREMENTS
The device should be stored at room temperature (15-30ºC).
MRI INFORMATION

Static magnetic field of 3-Tesla or less:Non-clinical testing has demonstrated that the iStent infinite
Trabecular Micro-Bypass Stent, Model iS3 is MR Conditional.
A patient with this device can be safely scanned in an MR systemmeeting the following conditions:• Static magnetic field: 3T or less
• Maximum spatial gradient magnetic field of 4,000 gauss/cm(40 T/m)• •Maximum MR system reported, whole body averaged
specific absorption rate (SAR) of 4-W/kg (First Level Controlled
Operating Mode)
Under the scan conditions defined above, the iStent infinite Trabecular
Micro-Bypass Stent, Model iS3 is not expected to produce a clinicallysignificant temperature rise after 15 minutes of continuous scanning.
In non-clinical testing, the image artifact caused by the device extends
less than 15 mm from the device when imaged with a gradient echopulse sequence and a 3T MRI system.

Use By (year-month-day)
Do not use if package is damaged
Sterilized by Gamma Irradiation

POTENTIAL COMPLICATIONSIntraoperative or postoperative adverse events may be device-related
or non-device related.
Potential intraoperative events are as follows:• Choroidal hemorrhage or effusion• Crystalline lens touched by injector• Posterior capsular bag rupture, in case of combined cataractsurgery• Prolonged anterior chamber collapse• Significant corneal injury• Significant damage to trabecular meshwork• Significant hyphema• Significant iris damage• Vitreous loss or vitrectomy, in case of combined cataract surgery• Stent malposition or loose stent inside eye requiring reacquisition
Potential postoperative events are as follows:• Choroidal complication (massive hemorrhage or effusion)• Chronic hypotony• Clinically significant cystoid macular edema• Endophthalmitis• Flat anterior chamber• Significant loss of best corrected visual acuity (BCVA)• Intraocular inflammation (non-preexisting)• IOL dislocation (in pseudophakic eyes)• IOP increase requiring management with oral or intravenous
medications or with surgical intervention• Pupillary block• Retinal complications (dialysis, flap tears, detachment, orproliferative vitreoretinopathy)• Secondary surgical intervention including, but not limited to, thefollowing :¶ Trabeculectomy¶ IOL repositioning or removal¶ Stent repositioning or removal• Significant corneal complications including edema, opacification,
decompensation• Significant damage to the trabecular meshwork• Significant hyphema• Significant iris damage• Stent dislocation or malposition• Stent obstruction

Definition

30 oC
15 Co

Temperature Storage
Requirements
MR Conditional

Rx Only

For Prescription use only
Consult Instructions For Use
Manufacturer
Quantity
Single sterile barrier system withprotective packaging outside

Glaukos Corporation
229 Avenida Fabricante
San Clemente, CA 92672 US
Tel: 1.949.367.9600,
Fax: +1.949.367.9984

www.glaukos.com
Glaukos® and iStent infinite® are registered trademarks of
Glaukos Corporation.
Tyvek® is a registered trademark of DuPont USA.