Device Dossier

Vitrectomy fluid/gas handling instrument

Device Dossier for Vitrectomy fluid/gas handling instrument (Vitrectomy fluid/gas handling instrument, Class IIa, sponsor IQ Medical). ARTG record,…

Intended purpose

A sterile, hand-operated ophthalmic surgical instrument that is used as an active-passive back flush needle during retinal surgery, to facilitate and/or control the removal of fluids or gasses within the posterior segment of the eye. It is intended to allow for aspiration of residual liquid or gas by either passive suction through the increase of intraocular pressure, or actively if connected to an Irrigation/aspiration console. It consists of a handle with a blunt or soft tip that is inserted into the eye, tubing for aspiration and an integral silicone backflush reservoir that enables fine control of the aspiration by hand-applied pressure to the reservoir opening or closing the integrated vent. This reservoir is also used for retrograde flushing of incarcerated tissue during aspiration. Contact with the retina is made with the flexible brush at the operating end of the cannula.

TGA Public Summary