Phakic Toric Intraocular Lens
Basic Information
- Device Name
- Phakic Toric Intraocular Lens
- Trade Name
- Visian Toric ICL (IMPLANTABLE COLLAMER LENS)
- PMA Number
- P030016
- Supplement Number
- S001
- Device Class
- FDA Class 3
- Product Code
- QCB
- Generic Name
- Phakic toric intraocular lens
- Regulation Number
- 886.3600
- Medical Specialty
- Ophthalmic
- Advisory Committee
- Ophthalmic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- September 13, 2018
- Date Received
- April 28, 2006
- Supplement Type
- Panel Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
- Docket Number
- 18M-3503
Advisory Committee 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.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QCB | Phakic Toric Intraocular Lens | FDA class 3 | Ophthalmic |