Device Dossier
Ophthalmic knife, single-use
Device Dossier for Ophthalmic knife, single-use (Ophthalmic knife, single-use, Class IIa, sponsor IQ Medical). ARTG record, intended purpose, GMDN…
- GMDN category: Ophthalmic knife, single-use
Intended purpose
The TrabEx is a single-use manual ophthalmic surgical instrument intended to remove a strip of the Trabecular Meshwork for the management of infantile and adult glaucoma. This is achieved by improving Intraocular Pressure (IOP) through surgically removing a strip of the trabecular meshwork through hand-controlled excision, allowing for exposure of collector channels so the ocular humor can then flow through those collector channels. It is designed as a one-piece instrument with a sharp, trapezoidal single-edged or double-edged cutting blade at the distal tip and a handle at the proximal end. It can have a variety of blade edge shapes, and be either single our dual-bladed at the distal end.