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.
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
| Device | Boston Orthokeratology (oprifocon A) Shaping Lens for Overnight Wear for Bausch & Lomb, Vision Shaping Treatment |
| Classification Name | Lens, Contact, Orthokeratology, Overnight |
| Generic Name | Lens, Contact, Orthokeratology, Overnight |
| Applicant | BAUSCH & LOMB |
| Date Received | 2018-05-25 |
| Decision Date | 2018-07-19 |
| PMA | P010062 |
| Supplement | S011 |
| Product Code | NUU |
| Docket Number | Premarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radia |
| Advisory Committee | Ophthalmic |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BAUSCH & LOMB 1400 North Goodman St. rochester, NY 14603-0450 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P010062 | Original Filing | |
| S011 | 2018-05-25 | Real-time Process |
| S010 | 2016-06-27 | 30-day Notice |
| S009 | 2011-05-31 | 30-day Notice |
| S008 | 2010-10-20 | Normal 180 Day Track No User Fee |
| S007 | 2009-10-13 | Normal 180 Day Track No User Fee |
| S006 | 2008-01-31 | Real-time Process |
| S005 | 2006-12-21 | Real-time Process |
| S004 | 2006-01-27 | 135 Review Track For 30-day Notice |
| S003 | 2005-04-18 | Normal 180 Day Track No User Fee |
| S002 | 2004-09-01 | Real-time Process |
| S001 | 2004-07-06 | Real-time Process |