Safety


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:

  • Migration
  • Exposure or extrusion
  • Blockage
  • Choroidal effusion or haemorrhage
  • Hypotony maculopathy
  • Bleb-related complications
  • Endophthalmitis and other known complications of intraocular surgery (e.g. flat or shallow chamber, hyphema, corneal oedema, macular oedema, retinal detachment, vitreous haemorrhage, 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 minimise 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.