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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.
 
DeviceFINEVISION HP Trifocal IOLs
Generic Nameintraocular lens
ApplicantBeaver Visitec International, Inc.
500 Totten Pond Rd.
Waltham, MA 02451
PMA NumberP240038
Supplement NumberS003
Date Received07/01/2026
Decision Date09/25/2026
Product Codes HQL MFK 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for an extension of the device shelf life from 3 years to 5 years, and expanded storage condition range to 2-35°C, for the FINEVISION HP Trifocal intraocular lens.
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