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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.
 
DeviceThe EVO/EVO+ Visian Implantable Collamer Lens (ICL)
Generic NameLens, intraocular, phakic
ApplicantSTAAR Surgical Company
1911 Walker Ave.
Monrovia, CA 91016
PMA NumberP030016
Supplement NumberS051
Date Received09/15/2025
Decision Date03/04/2026
Product Codes MTA QCB 
Advisory Committee Ophthalmic
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
a software update to the optical metrology system used in the production of EVO/EVO+ Visian and Visian Toric Implantable Collamer® Lenses to incorporate lens size and lens model identification inspection capabilities, in addition to the existing dioptric power and image quality measurement functions.
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