Device Dossier

Healon Pro - Aqueous/vitreous humour replacement medium

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

Intended purpose

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

Functional description

The device 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 10 mg/ ml (1.0%) dissolved in a physiological buffer.

TGA Public Summary