Device Dossier

Healon GV Pro - Aqueous/vitreous humour replacement medium

Device Dossier for Healon GV Pro - Aqueous/vitreous humour replacement medium (Aqueous/vitreous humour replacement medium, Class III, sponsor AMO). ARTG…

Intended purpose

The Healon GV PRO OVD is indicated for use as a surgical aid in various anterior segment procedures, such as cataract extraction and (IOL) implantation.

Functional description

The Healon GV PRO Ophthalmic Viscosurgical Device (OVD) is a steam-sterilized, non-pyrogenic solution of a highly purified, non-inflammatory, high molecular mass fraction of sodium hyaluronate (HA) derived by microbial fermentation. The HA is provided at a concentration of 18 mg/ml (1.8%) dissolved in a physiological buffer.

TGA Public Summary