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Abbreviated DFU XEN Gel Implant ^1,2

Xen injector

The XEN Injector is a single use mechanical delivery system for the XEN Gel Implant. The Gel Implant is preloaded in the XEN Injector which houses the Gel Implant during insertion and delivery into the eye. The XEN Injector allows the surgeon to advance and deliver the Gel Implant to the desired location.

Indications

The XEN Gel Implant is intended to reduce intraocular pressure in patients with primary open angle glaucoma (POAG), pseudoexfoliative glaucoma (PEXG), pigmentary glaucoma, or uveitic glaucoma where previous medical treatments have failed.

Contraindications

The XEN Gel Implant is contraindicated under the following circumstances or conditions: Angle closure glaucoma, previous glaucoma shunt/valve in the target quadrant, presence of conjunctival scarring, prior conjunctival surgery or other conjunctival pathologies (e.g., pterygium) in the target quadrant, active inflammation (e.g., blepharitis, conjunctivitis, keratitis, uveitis), active iris neovascularization or neovascularization of the iris within six months of the surgical date, anterior chamber intraocular lens, presence of intraocular silicone oil, vitreous present in the anterior chamber, impaired episcleral venous drainage (e.g., Sturge-Weber or nanophthalmos or other evidence of elevated venous pressure), known or suspected allergy or sensitivity to drugs required for the surgical procedure or any of the device components (e.g., porcine products or glutaraldehyde), history of dermatologic keloid formation.

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, abscess, angle recession, cataract formation/progression, hypopyon, iris atrophy, punctate keratitis, scleritis, prion diseases, infections, intraocular foreign bodies, wound leak, need for additional surgical intervention, and other known complications of intraocular surgery (e.g., flat or shallow chamber, hyphema, corneal edema, macular edema, retinal detachment, vitreous hemorrhage, uveitis, hyperemia, corneal decompensation, corneal endothelial cell loss).

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. 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. XEN 45 Direction for use, updated May 2025

2. XEN 63 Direction for use, updated May 2025

SE-XEN-250004 – October 2025