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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 Implantable Collamer Lens for Myopia
Generic Namelens, intraocular, phakic
STAAR Surgical Company
1911 walker ave.
monrovia, CA 91016
PMA NumberP030016
Supplement NumberS033
Date Received07/06/2017
Decision Date08/04/2017
Product Code MTA 
Advisory Committee Ophthalmic
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Addition of an autoclave for use in the sterilization of the Visian Implantable Collamer Lens (ICL) and the Collamer Intraocular Lens (CIOL) at the Monrovia, California facility.