Device Dossier

Vitrectomy fluid/gas handling instrument

Device Dossier for Vitrectomy fluid/gas handling instrument (Vitrectomy fluid/gas handling instrument, Class IIa, sponsor Beaver-Visitec International).…

Intended purpose

Intended to handle fluids and gases during vitreoretinal surgery. It is used to control the extraction of fluids, internal drainage of subretinal fluid, retinal fold manipulation, and simultaneous or sequential gas/fluid exchange. 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. Tissue manipulators can be used in cases of retina disorders to manipulate the retina and retinal folds.

TGA Public Summary