PMA P030016S001
- Device
- Visian Toric ICL (IMPLANTABLE COLLAMER LENS)
- Applicant
- STAAR Surgical Company
- PMA number
- P030016
- Supplement
- S001
- Product code
- QCB
- Decision date
- 2018-09-13
- Classification
- Phakic Toric Intraocular Lens
- Generic name
- Phakic toric intraocular lens
- Approval order statement
- 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.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf3/P030016S001B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- Visian Toric ICL (IMPLANTABLE COLLAMER LENS)
- Applicant
- STAAR Surgical Company
- PMA number
- P030016
- Supplement
- S001
- Product code
- QCB
- Generic name
- Phakic toric intraocular lens
- Decision date
- 2018-09-13
- Decision code
- APPR
- Date received
- 2006-04-28
- Supplement type
- Panel Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- 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.