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 the following indication: night & day soft contact lenses are also indicated for therapeutic use. Use as a bandage to protect the cornea and to relieve corneal pain during the treatment of acute or chronic ocular pathologies such as bullous keratopathy, corneal erosions, entropion, corneal edema, and corneal dystrophies as well as post-surgical conditions resulting from cataract extraction and corneal surgery. Night & day soft contact lenses for therapeutic use can also provide optical correction during healing if required.
| Device | NIGHT & DAY 30 NIGHT EXTENDED WEAR SOFT CONTACT LENS |
| Classification Name | Lenses, Soft Contact, Extended Wear |
| Generic Name | Lenses, Soft Contact, Extended Wear |
| Applicant | Alcon Laboratories, Inc. |
| Date Received | 2003-02-24 |
| Decision Date | 2003-03-19 |
| PMA | P010019 |
| Supplement | S002 |
| Product Code | LPM |
| 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, Inc. 6201 South Freeway fort Worth, TX 76134-2099 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P010019 | Original Filing | |
| S083 | 2022-06-09 | 30-day Notice |
| S082 | ||
| S081 | 2021-12-17 | 30-day Notice |
| S080 | 2021-08-31 | 30-day Notice |
| S079 | 2021-08-16 | 30-day Notice |
| S078 | 2021-06-04 | Normal 180 Day Track No User Fee |
| S077 | 2020-11-17 | 30-day Notice |
| S076 | 2020-02-18 | 30-day Notice |
| S075 | 2019-12-23 | 30-day Notice |
| S074 | 2019-11-13 | 30-day Notice |
| S073 | 2019-08-02 | 30-day Notice |
| S072 | ||
| S071 | 2019-02-21 | 30-day Notice |
| S070 | 2018-11-27 | 30-day Notice |
| S069 | ||
| S068 | 2018-07-31 | 30-day Notice |
| S067 | 2018-07-13 | 30-day Notice |
| S066 | 2018-06-27 | 30-day Notice |
| S065 | 2018-04-30 | 30-day Notice |
| S064 | 2018-03-22 | 30-day Notice |
| S063 | 2018-02-02 | 30-day Notice |
| S062 | 2017-12-18 | Real-time Process |
| S061 | 2017-10-17 | 30-day Notice |
| S060 | 2017-09-27 | 30-day Notice |
| S059 | 2017-08-29 | 30-day Notice |
| S058 | 2017-08-28 | 30-day Notice |
| S057 | ||
| S056 | 2017-08-09 | 30-day Notice |
| S055 | 2017-06-12 | 30-day Notice |
| S054 | 2017-03-24 | 30-day Notice |
| S053 | 2017-01-23 | 135 Review Track For 30-day Notice |
| S052 | 2016-08-12 | 30-day Notice |
| S051 | 2016-06-01 | 30-day Notice |
| S050 | 2016-04-22 | Normal 180 Day Track |
| S049 | 2016-03-11 | 30-day Notice |
| S048 | 2016-03-01 | 30-day Notice |
| S047 | 2016-02-26 | 30-day Notice |
| S046 | 2016-02-16 | 30-day Notice |
| S045 | 2016-02-09 | 30-day Notice |
| S044 | 2016-01-28 | 30-day Notice |
| S043 | 2015-12-21 | 30-day Notice |
| S042 | 2015-11-12 | 30-day Notice |
| S041 | 2015-09-21 | 30-day Notice |
| S040 | 2015-07-30 | 30-day Notice |
| S039 | 2015-05-01 | 30-day Notice |
| S038 | 2015-04-08 | 30-day Notice |
| S037 | 2015-03-03 | 30-day Notice |
| S036 | 2013-11-12 | 30-day Notice |
| S035 | 2013-08-02 | 30-day Notice |
| S034 | 2012-09-27 | 30-day Notice |
| S033 | 2012-07-10 | 30-day Notice |
| S032 | 2012-05-04 | 30-day Notice |
| S031 | 2012-04-23 | 30-day Notice |
| S030 | 2012-04-16 | 30-day Notice |
| S029 | 2012-02-01 | 30-day Notice |
| S028 | 2011-12-14 | Normal 180 Day Track No User Fee |
| S027 | 2011-12-12 | 30-day Notice |
| S026 | 2011-09-30 | 30-day Notice |
| S025 | 2011-06-06 | Normal 180 Day Track No User Fee |
| S024 | 2011-04-21 | 30-day Notice |
| S023 | 2011-04-13 | 30-day Notice |
| S022 | 2011-03-25 | 135 Review Track For 30-day Notice |
| S021 | 2011-03-01 | Normal 180 Day Track No User Fee |
| S020 | 2011-02-14 | 30-day Notice |
| S019 | 2010-08-09 | 30-day Notice |
| S018 | 2010-08-06 | 30-day Notice |
| S017 | 2010-06-29 | 30-day Notice |
| S016 | ||
| S015 | 2010-05-05 | 30-day Notice |
| S014 | 2010-03-03 | 30-day Notice |
| S013 | 2010-03-02 | 30-day Notice |
| S012 | ||
| S011 | 2008-08-25 | Normal 180 Day Track No User Fee |
| S010 | 2008-07-07 | 30-day Notice |
| S009 | 2008-04-07 | Normal 180 Day Track No User Fee |
| S008 | 2007-12-17 | Real-time Process |
| S007 | 2007-09-14 | Normal 180 Day Track No User Fee |
| S006 | 2007-04-02 | Normal 180 Day Track No User Fee |
| S005 | 2006-11-20 | 30-day Notice |
| S004 | 2006-08-22 | Real-time Process |
| S003 | 2004-06-08 | Normal 180 Day Track |
| S002 | 2003-02-24 | Real-time Process |
| S001 | 2002-04-05 | Normal 180 Day Track |