Device Dossier
Pty Ltd - Glaucoma shunt
Device Dossier for Pty Ltd - Glaucoma shunt (Glaucoma shunt, Class IIb, sponsor Paragon Care). ARTG record, intended purpose, GMDN category — compiled by…
- GMDN category: Glaucoma shunt
Intended purpose
The PAUL® Glaucoma Implant is an invasive permanent intraocular implant. It is a glaucoma drainage device, intended to regulate intraocular pressure in the eyes of patients with refractory glaucoma. It is a single use device which should only be implanted by trained and experienced ophthalmic surgeons. It is contraindicated for patients with pre-existing conditions, including but not limited to inflammation, infections and/or no light perception.