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.
Approval for the focus night and day (lotrafilcon a) soft contact lenses for extended wear. The device will be marketed with the following trade names and indications: focus night and day (lotrafilcon a) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes and with up to approximately 1. 50 diopters of astigmatism. Focus night and day toric (lotrafilcon a) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia in phakic or aphakic persons with non-diseased eyes with 6. 00 diopters (d) or less of astigmatism. Focus night and day progressives (lotrafilcon a) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +3. 00 diopters (d) or less and who may have up to approximately 1. 50 diopters of astigmatism. The lenses may be prescribed for extended wear for up to 30 nights of continuous wear, with removal for disposal, or cleaning and disinfection prior to reinsertion, as recommended by the eye care professional.
Device | FOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES |
Classification Name | Lenses, Soft Contact, Extended Wear |
Generic Name | Lenses, Soft Contact, Extended Wear |
Applicant | Alcon Laboratories, Inc. |
Date Received | 2001-03-21 |
Decision Date | 2001-10-11 |
Notice Date | 2001-10-19 |
PMA | P010019 |
Supplement | S |
Product Code | LPM |
Docket Number | 01M-0479 |
Advisory Committee | Ophthalmic |
Expedited Review | No |
Combination Product | No |
Applicant Address | Alcon Laboratories, Inc. 6201 South Freeway fort Worth, TX 76134-2099 |
Summary: | Summary of Safety and Effectiveness |
Labeling: | Labeling |
Approval Order: | Approval Order |
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 |