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 for labeling changes for the advanced optics violet-shield model li61aov intraocular lens. The device, as modified, will be marketed under the trade name advanced optics violet-shield model li61aov intraocular lens and is indicated to be used for primary implantation for the correction of aphakia in adult patients where a cataractous lens has been removed by extracapsular cataract extraction methods. The lens is intended for placement in the ciliary sulcus or capsular bag.
| Device | LI61AOV (ADVANCED OPTICS VIOLET-SHIELD) LENS |
| Classification Name | Intraocular Lens |
| Generic Name | Intraocular Lens |
| Applicant | BAUSCH & LOMB |
| Date Received | 2006-03-30 |
| Decision Date | 2006-07-20 |
| PMA | P910061 |
| Supplement | S013 |
| Product Code | HQL |
| Advisory Committee | Ophthalmic |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BAUSCH & LOMB 50 Technology Drive irvine, CA 92618 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P910061 | Original Filing | |
| S027 | 2021-12-22 | 30-day Notice |
| S026 | 2020-12-11 | 30-day Notice |
| S025 | 2019-01-04 | 30-day Notice |
| S024 | ||
| S023 | 2016-05-31 | 30-day Notice |
| S022 | 2015-10-15 | 30-day Notice |
| S021 | ||
| S020 | 2013-07-31 | 30-day Notice |
| S019 | 2009-11-02 | 30-day Notice |
| S018 | 2009-06-09 | 30-day Notice |
| S017 | 2008-06-19 | 30-day Notice |
| S016 | 2008-04-03 | 30-day Notice |
| S015 | 2006-08-30 | Real-time Process |
| S014 | 2006-04-03 | Real-time Process |
| S013 | 2006-03-30 | Real-time Process |
| S012 | 2004-03-29 | Normal 180 Day Track No User Fee |
| S011 | 2004-03-18 | Real-time Process |
| S010 | 2003-06-23 | 30-day Notice |
| S009 | 2003-06-11 | Real-time Process |
| S008 | 1999-02-10 | Real-time Process |
| S007 | 1998-12-18 | Normal 180 Day Track |
| S006 | 1998-12-01 | Real-time Process |
| S005 | 1998-10-29 | 135 Review Track For 30-day Notice |
| S004 | 1998-09-18 | Real-time Process |
| S003 | 1998-08-07 | Normal 180 Day Track |
| S002 | ||
| S001 | 1997-06-10 | Normal 180 Day Track |