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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.
 
DeviceVisian® Toric Implantable Collamer® Lens (TICL)
Generic NamePhakic toric intraocular lens
ApplicantSTAAR Surgical Company
1911 Walker Ave.
Monrovia, CA 91016
PMA NumberP030016
Supplement NumberS049
Date Received06/26/2025
Decision Date12/10/2025
Product Codes MTA QCB 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for updates to labeling for the Visian® Toric Implantable Collamer Lens (TICL)™, EVO/EVO+ Visian® ICL™, and EVO/EVO+ Visian® TICL™ to reflect the findings of the P030016/S001 PMA New Enrollment Post-Approval Study.
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