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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.
 
DeviceEVO/EVO+VISIAN Implantable Collamer Lens
Generic NameLens, intraocular, phakic
ApplicantSTAAR Surgical Company
1911 WALKER AVE.
MONROVIA, CA 91016
PMA NumberP030016
Supplement NumberS035
Date Received11/01/2018
Decision Date03/25/2022
Product Codes MTA QCB 
Docket Number 22M-0462
Notice Date 03/29/2022
Advisory Committee Ophthalmic
Clinical TrialsNCT04283149
Supplement TypePanel Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
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.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
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