Safety information

Indication

The XEN gel implant is intended to reduce intraocular pressure (IOP) in patients with primary open angle glaucoma where previous medical treatments have failed.

Contraindications

The XEN gel implant is not suitable for patients with:

  • Angle-closure glaucoma where the drainage angle of the eye has not been surgically opened
  • A glaucoma drainage device previously implanted in the target quadrant
  • The presence of 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) within six months of the surgical date
  • Abnormal formation of new blood vessels on the iris surface (the coloured part of the eye)
  • 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 the eye
  • Vitreous (the transparent jelly-like tissue that is found behind the lens) present in the anterior chamber
  • A known or suspected allergy to drugs required for the surgical procedure or any component of the device (e.g. porcine products or glutaraldehyde)
  • A history of keloid formation

Warnings

The following may occur in conjunction with the use of the XEN gel implant:

  • Implant moving to another part of the eye (implant migration)
  • Implant exposure or extrusion
  • Implant blockage
  • A build-up of fluid between the choroid (inner layer of blood vessels) and the sclera (white outer layer of the eyeball) known as choroidal effusion
  • Blood in the eye (haemorrhage)
  • Very low eye pressure (hypotony)
  • Wound leak
  • Need for additional surgical intervention
  • Other eye surgery complications

Precautions

The following precautions will be taken:

  • 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 (IOP)
  • In order to minimise trauma to the eye and associated complications, it is essential that the XEN gel implant is placed in the proper subconjunctival location

Side effects

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. 

Reporting of side effects

If you get any side effects with XEN, please report them to your eye specialist and to Allergan at ProductSurveillance_EAME@Allergan.com Opens mailbox By reporting side effects you can help provide more information on the safety of XEN.

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