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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.
 
DeviceClearView 3 IOL
Generic NameLens, multifocal intraocular
Regulation Number886.3600
ApplicantLenstec, Inc.
1765 Commerce Ave. N
St. Petersburg, FL 33716
PMA NumberP200020
Supplement NumberS011
Date Received01/05/2026
Decision Date03/25/2026
Product Code MFK 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for an extension of the power range from +15.0 through +30.0D to +10.0 through +36.0D for the ClearView 3 intraocular lenses (IOLs)
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