Device Dossier

Aqueous/vitreous humour replacement medium

Device Dossier for Aqueous/vitreous humour replacement medium (Aqueous/vitreous humour replacement medium, Class IIa, sponsor Carl Zeiss). ARTG record,…

Intended purpose

A substance used to temporarily replace the aqueous or vitreous humor within the eye, especially for surgical interventions involving the anterior chamber of the eye, such as cataracts, corneal transplants and glaucoma operations. The product is used to create and maintain a deep chamber and space in which to work within the anterior chamber of the eye, thus minimising the risk of mechanical damage to any of the ocular structures. The product can also be used to provide a protective barrier during phacoemulsification, maintain the space in the anterior chamber, and can be used to lubricate the surgical instruments used during the procedure.

TGA Public Summary