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…
- GMDN category: Vitrectomy fluid/gas handling instrument
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.