- Device
- EVO/EVO+VISIAN Implantable Collamer Lens
- Applicant
- STAAR Surgical Company
- PMA number
- P030016
- Supplement
- S035
- Product code
- MTA
- Generic name
- Lens, intraocular, phakic
- Decision date
- 2022-03-25
- Decision code
- APPR
- Date received
- 2018-11-01
- Supplement type
- Panel Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the EVO/EVO+ Visian Implantable Collamer Lens. The ICL is indicated for use in patients 21-45 years of age:1. for the correction of myopia with spherical equivalent ranging from -3.0D to less than or equal to-15.0D with less than or equal to 2.5D of astigmatism at the spectacle plane;2. for the reduction of myopia with spherical equivalent ranging from greater than -15.0D to -20.0D with less than or equal to 2.5D of astigmatism at the spectacle plane;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 1 year prior to implantation); and4.The ICL is intended for placement in the posterior chamber (ciliary sulcus) of the phakic eye.The EVO TICL 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 0.5 D for both spherical equivalent and cylinder for 1 year prior to implantation); and4. The TICL is intended for placement in the posterior chamber (ciliary sulcus) of the phakic eye.