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 modify the directions for use for all legally marketed iols under the referenced pmas, to indicate the iols for use in adult patients. Previously, the iols were indicated for use in persons 60 years of age or older. These devices, as modified, will be marketed under their approved trade names and are indicated for primary implantation for the visual correction of aphakia in adult patients where a cataractous lens has been removed by extracapsular extraction methods.
| Device | SILICONE INTRAOCULAR LENSES |
| Classification Name | Intraocular Lens |
| Generic Name | Intraocular Lens |
| Applicant | BAUSCH & LOMB |
| Date Received | 2003-06-11 |
| Decision Date | 2003-08-13 |
| PMA | P910061 |
| Supplement | S009 |
| Product Code | HQL |
| 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 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 |