Device Dossier

Aqueous/vitreous humour replacement medium kit

Device Dossier for Aqueous/vitreous humour replacement medium kit (Aqueous/vitreous humour replacement medium kit, Class IIa, sponsor Lumos Medical).…

Intended purpose

Intended as a volume substitute for aqueous humor during intraocular operations, such as lens extraction and insertion of an intraocular lens. It consists of hydroxypropylmethylcellulose (HPMC) and is non-implantable. At the end of surgery, the product must be removed completely using a suitable irrigation/ aspiration device.

TGA Public Summary