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 vistakon (senofilcon a) contact lens, clear and visibility tinted with uv blocker. The device is indicated for use as follows: the vistakon (senofilcon a) soft contact lens (spherical) is indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who have 1. 00d or less of astigmatism. The vistakon (senofilcon a) multifocal soft contact lens is indicated for the optical correction of distance and near vision in presbyopic, phakic or aphakic persons with non-diseased eyes who may have 0. 75d of astigmatism or less. The vistakon (senofilcon a) toric soft contact lens is indicated for the optical correction of visual acuity in phakic or aphakic persons with non-diseased eyes that are hyperopic or myopic and may have 10. 00d of astigmatism or less. The vistakon (senofilcon a) multifocal-toric soft contact lens is indicated for the optical correction of distance and near in presbyopic phakic or aphakic persons with non-diseased eyes who may have 10. 00d of astigmatism or less. The vistakon (senofilcon a) uv blocking soft contact lens help protect against transmission of harmful uv radiation to the cornea and into the eye. Eye care professionals may prescribe the lenses either for single-use disposable wear or frequent/planned replacement wear with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear the lenses may be cleaned and disinfected using a chemical disinfection system only. Vistakon (senofilcon a) contact lenses may be prescribed for daily wear and extended wear for up to 6 nights/7 days of continuous wear. It is recommended that the contact lens wearer first be evaluated on a daily wear schedule. If successful, then a gradual introduction of extended wear can be followed as determined by the prescribing eye care professional.
| Device | VISTAKON (SENOFILCON A) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKER |
| Classification Name | Lenses, Soft Contact, Extended Wear |
| Generic Name | Lenses, Soft Contact, Extended Wear |
| Applicant | VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR |
| Date Received | 2004-11-15 |
| Decision Date | 2005-12-20 |
| Notice Date | 2005-12-27 |
| PMA | P040045 |
| Supplement | S |
| Product Code | LPM |
| Docket Number | 05M-0504 |
| Advisory Committee | Ophthalmic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR 7500 Centurion Parkway suite 100 - Erca jacksonville, FL 32256 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P040045 | Original Filing | |
| S129 | 2022-11-21 | 30-day Notice |
| S128 | 2022-08-04 | 30-day Notice |
| S127 | ||
| S126 | 2022-05-24 | 30-day Notice |
| S125 | 2022-05-17 | 30-day Notice |
| S124 | 2022-03-30 | 30-day Notice |
| S123 | 2021-11-12 | 30-day Notice |
| S122 | 2021-07-28 | 30-day Notice |
| S121 | 2021-05-10 | 30-day Notice |
| S120 | 2020-10-29 | 30-day Notice |
| S119 | 2020-10-26 | 30-day Notice |
| S118 | 2020-09-04 | Normal 180 Day Track |
| S117 | ||
| S116 | ||
| S115 | 2020-05-19 | 30-day Notice |
| S114 | 2020-05-05 | 30-day Notice |
| S113 | ||
| S112 | 2019-11-25 | 30-day Notice |
| S111 | ||
| S110 | 2019-08-30 | 30-day Notice |
| S109 | 2019-05-24 | 30-day Notice |
| S108 | 2019-04-25 | 30-day Notice |
| S107 | 2019-04-25 | 30-day Notice |
| S106 | 2019-04-03 | 30-day Notice |
| S105 | 2019-03-28 | 30-day Notice |
| S104 | 2018-12-21 | 30-day Notice |
| S103 | 2018-12-21 | 30-day Notice |
| S102 | 2018-10-30 | 30-day Notice |
| S101 | 2018-09-04 | 30-day Notice |
| S100 | 2018-07-03 | 30-day Notice |
| S099 | 2018-06-08 | 30-day Notice |
| S098 | 2018-05-25 | 30-day Notice |
| S097 | 2018-04-05 | 30-day Notice |
| S096 | 2018-03-07 | 30-day Notice |
| S095 | 2018-02-16 | 30-day Notice |
| S094 | 2018-02-12 | 30-day Notice |
| S093 | 2018-01-25 | 30-day Notice |
| S092 | 2018-01-17 | 30-day Notice |
| S091 | 2017-11-29 | 30-day Notice |
| S090 | 2017-11-21 | 30-day Notice |
| S089 | 2017-11-13 | 30-day Notice |
| S088 | 2017-11-06 | 30-day Notice |
| S087 | 2017-10-20 | 30-day Notice |
| S086 | 2017-10-17 | 30-day Notice |
| S085 | 2017-10-12 | 30-day Notice |
| S084 | 2017-09-27 | 30-day Notice |
| S083 | 2017-09-27 | 30-day Notice |
| S082 | 2017-08-16 | 30-day Notice |
| S081 | 2017-08-11 | 30-day Notice |
| S080 | 2017-08-01 | 30-day Notice |
| S079 | 2017-07-25 | 30-day Notice |
| S078 | 2017-07-18 | 30-day Notice |
| S077 | 2017-07-03 | 30-day Notice |
| S076 | 2017-05-24 | 30-day Notice |
| S075 | 2017-05-24 | 30-day Notice |
| S074 | 2017-05-24 | 30-day Notice |
| S073 | 2017-05-24 | 30-day Notice |
| S072 | 2017-05-24 | 30-day Notice |
| S071 | 2017-04-14 | 30-day Notice |
| S070 | 2017-04-10 | 30-day Notice |
| S069 | 2017-03-27 | 30-day Notice |
| S068 | 2017-01-27 | 30-day Notice |
| S067 | 2017-01-27 | 30-day Notice |
| S066 | 2017-01-24 | 30-day Notice |
| S065 | 2017-01-17 | 30-day Notice |
| S064 | 2016-12-20 | 30-day Notice |
| S063 | 2016-12-14 | 30-day Notice |
| S062 | 2016-11-22 | 30-day Notice |
| S061 | 2016-11-01 | 30-day Notice |
| S060 | 2016-09-30 | 30-day Notice |
| S059 | 2016-09-28 | 30-day Notice |
| S058 | 2016-09-22 | 30-day Notice |
| S057 | 2016-09-13 | 30-day Notice |
| S056 | 2016-04-11 | 30-day Notice |
| S055 | 2016-02-08 | 30-day Notice |
| S054 | 2015-12-18 | 30-day Notice |
| S053 | 2015-11-25 | 30-day Notice |
| S052 | 2015-11-02 | 30-day Notice |
| S051 | 2015-04-09 | 30-day Notice |
| S050 | 2015-04-03 | 30-day Notice |
| S049 | 2014-12-23 | 30-day Notice |
| S048 | 2014-12-17 | 30-day Notice |
| S047 | 2014-08-12 | 30-day Notice |
| S046 | 2014-07-15 | 30-day Notice |
| S045 | 2014-06-26 | 30-day Notice |
| S044 | 2014-04-02 | 30-day Notice |
| S043 | 2014-03-14 | 30-day Notice |
| S042 | 2014-02-26 | 30-day Notice |
| S041 | 2013-11-18 | Normal 180 Day Track |
| S040 | 2013-07-26 | 30-day Notice |
| S039 | 2013-04-02 | 30-day Notice |
| S038 | ||
| S037 | 2013-02-05 | 30-day Notice |
| S036 | 2013-01-28 | 30-day Notice |
| S035 | 2012-12-21 | 30-day Notice |
| S034 | 2012-11-19 | 30-day Notice |
| S033 | 2012-07-06 | 30-day Notice |
| S032 | 2012-02-21 | 30-day Notice |
| S031 | 2012-01-11 | 30-day Notice |
| S030 | 2011-11-23 | 30-day Notice |
| S029 | ||
| S028 | 2011-11-07 | 30-day Notice |
| S027 | 2011-09-30 | 30-day Notice |
| S026 | 2011-09-19 | 135 Review Track For 30-day Notice |
| S025 | 2011-09-12 | 30-day Notice |
| S024 | 2011-06-06 | 30-day Notice |
| S023 | 2011-05-23 | 30-day Notice |
| S022 | 2011-05-20 | 30-day Notice |
| S021 | 2011-05-17 | 30-day Notice |
| S020 | 2011-05-16 | 30-day Notice |
| S019 | 2011-05-12 | 30-day Notice |
| S018 | 2011-04-22 | 30-day Notice |
| S017 | 2010-10-08 | 30-day Notice |
| S016 | ||
| S015 | 2010-08-23 | 30-day Notice |
| S014 | 2010-06-28 | 135 Review Track For 30-day Notice |
| S013 | 2010-04-02 | 30-day Notice |
| S012 | 2010-03-10 | 135 Review Track For 30-day Notice |
| S011 | 2010-02-12 | 30-day Notice |
| S010 | 2010-01-25 | 30-day Notice |
| S009 | 2009-10-13 | 30-day Notice |
| S008 | 2009-07-09 | 30-day Notice |
| S007 | 2009-06-22 | Real-time Process |
| S006 | 2009-06-04 | 30-day Notice |
| S005 | 2009-05-20 | 30-day Notice |
| S004 | 2009-04-17 | 30-day Notice |
| S003 | 2007-11-20 | Real-time Process |
| S002 | 2007-10-23 | Normal 180 Day Track No User Fee |
| S001 | 2007-04-23 | Normal 180 Day Track |