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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
Generic NamePhakic toric intraocular lens
Regulation Number886.3600
ApplicantSTAAR Surgical Company
PMA NumberP030016
Supplement NumberS001
Date Received04/28/2006
Decision Date09/13/2018
Product Code QCB 
Docket Number 18M-3503
Notice Date 09/20/2018
Advisory Committee Ophthalmic
Supplement TypePanel Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
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.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress