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 indications statement, to indicate the iols for use in adult patients following cataract surgery. Previously, the iols were indicated for use in persons 60 years of age or older when extracapsular cataract extraction or phacoemulsification are performed or where a cataractous lens has been removed. The device is indicated for the replacement of the human lens to achieve visual correction of aphakia in adults following cataract surgery.
| Device | ACRYSOF UV-ABSORBING MULTI-PIECE PC IOL |
| Classification Name | Intraocular Lens |
| Generic Name | Intraocular Lens |
| Applicant | ALCON LABORATORIES |
| Date Received | 2004-04-16 |
| Decision Date | 2004-04-29 |
| PMA | P810032 |
| Supplement | S050 |
| 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 | 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 |