Device Dossier

Healon 5 Pro - Aqueous/vitreous humour replacement medium

Device Dossier for Healon 5 Pro - Aqueous/vitreous humour replacement medium (Aqueous/vitreous humour replacement medium, Class III, sponsor AMO). ARTG…

Intended purpose

The Healon5 PRO OVD is indicated for use as a surgical aid in various anterior segment procedures, such as cataract extraction, (IOL) implantation.

Functional description

The Healon 5 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 23 mg/ ml (2.3%) dissolved in a physiological buffer.

TGA Public Summary