Device Dossier

Visian ICL (Implantable Collamer Lens) Model Family V4c (VTICMO) - Posterior-chamber intraocular lens, phakic

Device Dossier for Visian ICL (Implantable Collamer Lens) Model Family V4c (VTICMO) - Posterior-chamber intraocular lens, phakic (Posterior-chamber…

Intended purpose

A toric ICL indicated for use in phakic eye treatment in adults 21- 60 years of age for: -The correction/reduction of myopia in adults ranging from -0.5D to -20.0D with less than or equal to 6.0D of astigmatism at the spectacle plane. -With an anterior chamber depth (ACD) equal to or greater than 3mm, as measured from the corneal endothelium to the anterior lens capsule.

Functional description

These toric ICLs, manufactured from porcine collagen/HEMA polymer, incorporate a forward vault to minimize contact with the central anterior capsule of the natural lens. They feature a single piece ICL design, a concave/convex optical zone and a 0.36mm central optic hole. The lens absorbs UV radiation and are folded using a STAAR injector.

TGA Public Summary