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.
Use the membrane filtration recovery method for bioburden testing of the acrysof® intraocular lenses.
| Device | PMMA Multi-Piece Posterior Chamber Intraocular Lenses |
| Classification Name | Intraocular Lens |
| Generic Name | Intraocular Lens |
| Applicant | ALCON LABORATORIES |
| Date Received | 2019-03-25 |
| Decision Date | 2019-04-22 |
| PMA | P810032 |
| Supplement | S069 |
| Product Code | HQL |
| Advisory Committee | Ophthalmic |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ALCON LABORATORIES 6201 S Freeway ft Worth, TX 76134 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P810032 | Original Filing | |
| S070 | 2019-07-05 | 30-day Notice |
| S069 | 2019-03-25 | 30-day Notice |
| S068 | 2019-03-25 | 30-day Notice |
| S067 | 2016-11-30 | 30-day Notice |
| S066 | 2016-08-03 | 30-day Notice |
| S065 | 2016-07-29 | 135 Review Track For 30-day Notice |
| S064 | 2015-12-09 | 30-day Notice |
| S063 | 2012-12-26 | Normal 180 Day Track No User Fee |
| S062 | 2012-10-01 | 30-day Notice |
| S061 | 2012-05-29 | 30-day Notice |
| S060 | 2011-06-24 | 30-day Notice |
| S059 | 2010-08-25 | 30-day Notice |
| S058 | 2010-08-10 | 30-day Notice |
| S057 | 2010-05-03 | 30-day Notice |
| S056 | 2010-05-03 | 30-day Notice |
| S055 | 2009-12-24 | 30-day Notice |
| S054 | 2009-06-30 | 30-day Notice |
| S053 | 2007-01-16 | 30-day Notice |
| S052 | 2006-07-24 | 30-day Notice |
| S051 | 2004-10-18 | 135 Review Track For 30-day Notice |
| S050 | 2004-04-16 | Real-time Process |
| S049 | 1996-08-08 | Normal 180 Day Track |
| S048 | 1995-08-09 | Normal 180 Day Track |
| S047 | 1995-01-31 | |
| S046 | ||
| S045 | 1993-02-17 | Normal 180 Day Track |
| S044 | 1992-04-16 | Normal 180 Day Track |
| S043 | 1991-08-21 | Normal 180 Day Track |
| S042 | 1991-07-10 | Normal 180 Day Track |
| S041 | 1991-06-25 | Normal 180 Day Track |
| S040 | ||
| S039 | ||
| S038 | ||
| S037 | ||
| S036 | ||
| S035 | ||
| S034 | ||
| S033 | ||
| S032 | ||
| S031 | ||
| S030 | 1988-12-29 | Normal 180 Day Track |
| S029 | ||
| S028 | 1988-12-22 | Normal 180 Day Track |
| S027 | 1988-11-23 | Normal 180 Day Track |
| S026 | 1988-11-14 | Normal 180 Day Track |
| S025 | 1988-11-08 | Normal 180 Day Track |
| S024 | 1988-08-30 | Normal 180 Day Track |
| S023 | ||
| S022 | ||
| S021 | 1988-06-28 | Normal 180 Day Track |
| S020 | 1988-05-31 | Normal 180 Day Track |
| S019 | ||
| S018 | ||
| S017 | 1988-05-09 | Normal 180 Day Track |
| S016 | 1987-12-24 | Normal 180 Day Track |
| S015 | 1987-12-14 | Normal 180 Day Track |
| S014 | 1987-12-14 | Normal 180 Day Track |
| S013 | 1987-05-18 | Normal 180 Day Track |
| S012 | 1987-04-15 | Normal 180 Day Track |
| S011 | 1986-12-22 | Normal 180 Day Track |
| S010 | 1986-08-14 | Normal 180 Day Track |
| S009 | ||
| S008 | 1986-01-23 | |
| S007 | 1985-12-24 | |
| S006 | 1985-08-09 | |
| S005 | 1984-01-26 | |
| S004 | 1983-07-21 | |
| S003 | 1983-06-17 | |
| S002 | ||
| S001 | 1982-12-28 |