Device Dossier
COMBIVISC™ - Aqueous/vitreous humour replacement medium kit
Device Dossier for COMBIVISC™ - Aqueous/vitreous humour replacement medium kit (Aqueous/vitreous humour replacement medium kit, Class III, sponsor Carl…
- GMDN category: Aqueous/vitreous humour replacement medium kit
Intended purpose
COMBIVISC™ consists of two ophthalmic viscosurgical devices (dispersive and cohesive) that can be used jointly or independently in surgical interventions to remove cataract and implant a prosthetic lens. COMBIVISC™ Dispersive coats the corneal endothelium providing a protective barrier during phacoemulsification, maintains the space in the anterior chamber and can be used to lubricate the surgical instruments used during the procedure. COMBIVISC™ Cohesive creates and maintains 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.
Functional description
The performance of COMBIVISC™ Cohesive and Dispersive are due to the rheological properties of the sodium hyaluronate solutions (1.5 and 3.0% respectively). They are clear viscoelastic solutions at rest, yet under pressure they are easily passed through a fine cannula. The Cohesive solution creates space and maintains a deep anterior chamber. The Dispersive solution offers corneal endothelial cell protection due to increased retention during phacoemulsification.