Device Dossier
EVO+ Visian Toric Implantable Collamer Lens (VTICL) , Model :VTICM5 - Posterior-chamber intraocular lens, phakic
Device Dossier for EVO+ Visian Toric Implantable Collamer Lens (VTICL) , Model :VTICM5 - Posterior-chamber intraocular lens, phakic (Posterior-chamber…
- GMDN category: Posterior-chamber intraocular lens, phakic
- Sponsor: Device Technologies
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
The VTICL features a single piece lens design with a concave/convex optic zone of 5.0 to 6.1 mm diameter (according to model and diopter) and a 0.36 mm diameter central hole in the optic known as the KS-AquaPORTÒ. The lens is manufactured in four overall diameters: 12.1, 12.6, 13.2, 13.7 mm to suit different eye sizes. The lenses are manufactured from a proprietary porcine collagen/HEMA polymer material with a refractive index of 1.442 at room temperature in Balanced Salt Solution.