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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.
 
DeviceBoston Orthokeratology (oprifocon A) Shaping Lens for Overnight Wear for Bausch & Lomb, Vision Shaping Treatment
Generic NameLens, contact, orthokeratology, overnight
Regulation Number886.5916
ApplicantBausch & Lomb
1400 N. Goodman St.
Rochester, NY 14603
PMA NumberP010062
Supplement NumberS011
Date Received05/25/2018
Decision Date07/19/2018
Product Code NUU 
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 to update the contact lens labeling to remove references to a tap water rinse and replace with a saline rinse, and update warnings related to use of water
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