DevicePMAs@therightstef:P030016_S001 JSONTXT 13 Projects

Approval for the Visian Toric ICL (Implantable Collamer Lens). The device is indicated for use in patients 21-45 years of age: 1) for the correction of myopic astigmatism with spherical equivalent ranging from -3.0D to less than or equal to -15.0D (in the spectacle plane) with cylinder (spectacle plane) of 1.0D to 4.0D; 2) for the reduction of myopic astigmatism with spherical equivalent ranging from greater than -15.0D to -20.0D (in the spectacle plane) with cylinder (spectacle plane) 1.0D to 4.0D; 3. with an anterior chamber depth (ACD) of 3.00 mm or greater, when measured from the corneal endothelium to the anterior surface of the crystalline lens and a stable refractive history (within 0.5D for both spherical equivalent and cylinder for 1 year prior to implantation); and4) The Visian TICL is intended for placement in the posterior chamber (ciliary sulcus) of the phakic eye.