Material 
for download or ordering

We have created printed materials that provide support for understanding the correct usage of our products and information to share with your patients. If you would like, we are happy to send these materials upon request. Alternatively, you can click on the download link below to access a PDF version.

Abbreviated DFU XEN Gel Implant^1,2

WARNINGS

The following may occur in conjunction with the use of the XEN Gel Implant: Gel Implant migration, Gel Implant exposure or extrusion,
Gel Implant blockage, choroidal effusion or hemorrhage, hypotony maculopathy, bleb related complications, choroidal detachment, conjunctival perforation, conjunctivitis, eye injury, fibrosis, high intraocular pressure, inflammation/irritation, irido-corneal touch, iridodialysis/iris rupture, iritis, lack of effectiveness, lacrimation, low intraocular pressure, malignant glaucoma, ocular pain, vision abnormalities, vision loss or endophthalmitis and other known complications of intraocular surgery (e.g., flat or shallow chamber,
hyphema, corneal edema, macular edema, retinal detachment, vitreous hemorrhage, uveitis).

PRECAUTIONS

1. The XEN Gel Implant and Injector should be carefully examined in the operating room prior to use.
2. The patient’s IOP should be monitored postoperatively. If the IOP is not adequately maintained after surgery, a therapeutic regimen or further intervention to reduce IOP should be considered.
3. In order to minimize trauma to the eye and associated complications, it is essential that the Gel Implant is placed in the proper subconjunctival location.
4. If increased resistance is observed at any time during the implantation procedure, stop the implantation procedure and use a new Injector.

References

1. XEN63 Directions For Use 5501-001 May-2019.

2. XEN45 Directions For Use 5507-001 Dec-2019

SE-OPHTHDM-240008 v1.0 July 2024