Device Dossier
Visian ICL (Implantable Collamer Lens) Model Family V4c (VICMO) - Posterior-chamber intraocular lens, phakic
Device Dossier for Visian ICL (Implantable Collamer Lens) Model Family V4c (VICMO) - Posterior-chamber intraocular lens, phakic (Posterior-chamber…
- GMDN category: Posterior-chamber intraocular lens, phakic
- Sponsor: Device Technologies
Intended purpose
An 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 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 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.