Device Dossier
Visian Implantable Collamer Lens - Posterior-chamber intraocular lens, phakic
Device Dossier for Visian Implantable Collamer Lens - Posterior-chamber intraocular lens, phakic (Posterior-chamber intraocular lens, phakic, Class III,…
- GMDN category: Posterior-chamber intraocular lens, phakic
- Sponsor: Device Technologies
Intended purpose
An ICL indicated for use in phakic eye treatment in patients 21-45 years of age for: • The correction/reduction of hyperopia in patients ranging from +0.5D to +16.0D at the spectacle plane. • With an anterior chamber depth (ACD) equal to or greater than 3.0 mm, as measured from the corneal endothelium to the anterior lens capsule.
Functional description
Visian ICL is intended to be placed entirely within the posterior chamber directly behind the iris and in front of the anterior capsule of the human crystalline lens. When correctly positioned, the lens functions as a refractive element to optically correct/ reduce hyperopia.