Device Dossier

Healon Endocoat - Aqueous/vitreous humour replacement medium

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

Intended purpose

Used in ophthalmic surgical procedures of the anterior segment, including: 1) Cataract surgery with an intraocular lens 2) Cataract surgery without an intraocular lens 3) Secondary intraocular lens implantation

Functional description

It is a sterile, non-pyrogenic preparation supplied in a disposable single use glass syringe, delivering 0.85mL of a solution of sodium hyaluronate in a physiological buffered salt solution.

TGA Public Summary