Device Dossier

Vitrectomy fluid/gas handling instrument

Device Dossier for Vitrectomy fluid/gas handling instrument (Vitrectomy fluid/gas handling instrument, Class IIa, sponsor Spectrum Surgical). ARTG…

Intended purpose

A sterile, hand-held, manual, ophthalmic surgical instrument intended to handle fluids and gases during vitreoretinal surgery. It is used for controlling the extraction of fluids, the internal drainage of subretinal fluid, retinal fold manipulation [proliferative vitreoretinopathie (PVR), retinotomies, translocation], and simultaneous or sequential gas/fluid exchange [fluid-air, air-gas, fluid-gas, fluid-perfluorocarbon (PFC), PFC-gas]. It consists of a handle with a blunt or soft tip, that is inserted into the eye, and is equipped with tubing for aspiration and an integral backflush reservoir for retrograde flushing of incarcerated tissue during aspiration.

TGA Public Summary