This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
| Device | ULTRA VIOLET (UV) AND NON-UV ABSORBING PMMA INTRAOCULAR LENSES |
| Classification Name | Intraocular Lens |
| Generic Name | Intraocular Lens |
| Applicant | Bausch & Lomb, Inc. |
| Date Received | 1984-08-27 |
| Decision Date | 1986-03-28 |
| Notice Date | 1986-07-01 |
| PMA | P840039 |
| Supplement | S |
| Product Code | HQL |
| Docket Number | 86M-0169 |
| Advisory Committee | Ophthalmic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Bausch & Lomb, Inc. 50 Technology irvine, CA 92618 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P840039 | Original Filing | |
| S064 | 2022-07-11 | 30-day Notice |
| S063 | 2019-01-04 | 30-day Notice |
| S062 | 2017-06-15 | 30-day Notice |
| S061 | 2016-05-17 | 30-day Notice |
| S060 | ||
| S059 | 2009-11-02 | 30-day Notice |
| S058 | 2009-06-19 | 30-day Notice |
| S057 | 2008-06-19 | 30-day Notice |
| S056 | 2008-04-03 | 30-day Notice |
| S055 | 2005-11-22 | Real-time Process |
| S054 | 2004-03-29 | Normal 180 Day Track No User Fee |
| S053 | 2004-03-18 | Real-time Process |
| S052 | 2003-06-23 | 30-day Notice |
| S051 | 2003-06-11 | Real-time Process |
| S050 | 2002-04-08 | Normal 180 Day Track |
| S049 | 1995-12-19 | Normal 180 Day Track |
| S048 | 1995-10-10 | Normal 180 Day Track |
| S047 | 1994-11-21 | Normal 180 Day Track |
| S046 | 1994-06-02 | Normal 180 Day Track |
| S045 | 1993-10-05 | Normal 180 Day Track |
| S044 | 1993-08-18 | Normal 180 Day Track |
| S043 | 1993-04-02 | Normal 180 Day Track |
| S042 | 1993-02-16 | Normal 180 Day Track |
| S041 | 1992-09-14 | Normal 180 Day Track |
| S040 | 1992-09-04 | Normal 180 Day Track |
| S039 | 1992-08-27 | Normal 180 Day Track |
| S038 | 1992-08-27 | Normal 180 Day Track |
| S037 | 1992-05-15 | Normal 180 Day Track |
| S036 | 1992-03-03 | Normal 180 Day Track |
| S035 | 1992-01-29 | Normal 180 Day Track |
| S034 | 1992-01-17 | Normal 180 Day Track |
| S033 | ||
| S032 | 1991-10-08 | Normal 180 Day Track |
| S031 | 1991-08-19 | Normal 180 Day Track |
| S030 | 1991-08-19 | Normal 180 Day Track |
| S029 | 1990-03-30 | Normal 180 Day Track |
| S028 | 1990-02-02 | Normal 180 Day Track |
| S027 | ||
| S026 | ||
| S025 | ||
| S024 | ||
| S023 | ||
| S022 | 1988-12-12 | Normal 180 Day Track |
| S021 | 1988-12-08 | Normal 180 Day Track |
| S020 | ||
| S019 | ||
| S018 | 1988-11-25 | Normal 180 Day Track |
| S017 | ||
| S016 | ||
| S015 | 1988-11-25 | Normal 180 Day Track |
| S014 | ||
| S013 | 1988-11-25 | Normal 180 Day Track |
| S012 | 1988-11-18 | Normal 180 Day Track |
| S011 | ||
| S010 | ||
| S009 | ||
| S008 | ||
| S007 | 1988-09-30 | Normal 180 Day Track |
| S006 | 1988-08-01 | Panel Track |
| S005 | ||
| S004 | ||
| S003 | 1987-07-30 | Normal 180 Day Track |
| S002 | 1987-03-16 | Normal 180 Day Track |
| S001 |