Glaucoma Treatment System is available for
the surgical management of refractory glaucomas, including cases where previous surgical treatment did not work, cases of primary open-angle glaucoma, and cases of pseudoexfoliative or pigmentary
glaucoma with open angles that are unresponsive to maximum tolerated medical therapy.IMPORTANT SAFETY INFORMATION
Who should not receive the XEN®
Glaucoma Treatment System?
This surgical treatment should not be used if you currently have any of the following: angle-closure glaucoma where the drainage angle of the eye has not been surgically
opened; a glaucoma drainage device previously implanted or scarring and pathologies of the conjunctiva (the clear membrane covering the white outer layer of the eye) in the area needed for this
implant; eye inflammation (such as inflammation of the eyelids, conjunctiva, cornea, or uvea); abnormal formation of new blood vessels on the iris (the colored part of the eye) surface; artificial
lens implanted in the anterior chamber (the space between your cornea, the outer transparent part of the eye, and the iris); silicone oil in your eye; and vitreous (the transparent jelly-like tissue
that is found behind the lens) present in the anterior chamber.What warnings should I be aware of?
Gel Stent complications may
include buildup of fluid between the choroid (inner layer of blood vessels) and the sclera (white outer layer of the eyeball), blood in the eye, very low eye pressure, implant moving to another part
of the eye, implant exposure, wound leak, need for additional surgical intervention, and other eye surgery complications. The safety and effectiveness of the XEN®
in neovascular, congenital, and infantile glaucoma has not been established. After the XEN®
Gel Stent procedure, to help avoid the possibility of implant damage, avoid
rubbing or pressing your fingers on the eye in the area where the XEN®
Gel Stent was implanted.
What precautions should I be aware of?
Before surgery, your doctor will check that the device and injector are not damaged. During surgery, your doctor will stop the
procedure if he or she observes increased resistance during implantation and will use a new XEN®
system. After surgery, your doctor should check and manage your eye pressure
appropriately. The safety and effectiveness of implanting more than one XEN®
Gel Stent in an eye has not been studied.
What are possible side
The most common side effects after surgery include reduction of vision, eye pressure becoming too low, an increase in eye pressure, and need
for an additional surgical procedure in the eye to release scar tissue (needling) around the implant under the conjunctiva. Talk to your doctor about other possible side effects.
Federal law restricts this device to sale by or on the order of a licensed physician. For the full Directions for Use, please visit www.allergan.com/xen/usa.htm or call 1-800-678-1605. Please call
1-800-433-8871 to report an adverse event.
© 2018 Allergan. All rights reserved. XEN®
is a registered trademark of AqueSys, Inc., an Allergan affiliate. Allergan®
design are trademarks of Allergan, Inc. XenGelStent.com
XEN108484-v3 03/19 190872