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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.
 
DeviceBausch & Lomb SofLens® (polymacon) Contact Lenses
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantBausch & Lomb, Inc.
1400 N. Goodman St.
Rochester, NY 14609
PMA NumberN16895
Supplement NumberS107
Date Received09/29/2025
Decision Date10/24/2025
Product Code LPM 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
use of a New Technology Moulding Machine in the Reverse Process III (RPIII) manufacturing process utilized in the Bausch + Lomb Waterford, Ireland manufacturing facility
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