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 labeling changes for the device. The changes will add additional statements to the "precautions" section of the package insert to alert both doctors and patients about visual symptoms and/or peripheral awareness that patients might experience due to a reduction in the visible light transmission. The following additional precaution statement will be added to the package insert: "due to reduction in light transmittance with cosmetically tinted lenses, some patients may experience visual symptoms while wearing acuvue 2 colours brand. In addition, some patients may experience peripheral awareness due to the opaque iris pattern. " the following additional precaution statement will be added to the patient instruction guides: "when wearing lenses that alter your eye color, you may notice temporary differences in your vision due to a change in the amount of light that enters your eyes. If these differences in vision persist when wearing acuvue 2 colours brand, it is important that you consult your eye care professional. "
| Device | ACUVUE 2 COLOURS (TM) BRAND (ETALFILCON A) CONTACT LENS WITH UV BLOCKER |
| Classification Name | Lenses, Soft Contact, Extended Wear |
| Generic Name | Lenses, Soft Contact, Extended Wear |
| Applicant | VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC. |
| Date Received | 2002-02-19 |
| Decision Date | 2002-03-18 |
| PMA | N18033 |
| Supplement | S037 |
| Product Code | LPM |
| Advisory Committee | Ophthalmic |
| Supplement Type | Special (immediate Track) |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC. 7500 Centurion Pkwy. jacksonville, FL 32256 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| N18033 | Original Filing | |
| S110 | 2022-11-21 | 30-day Notice |
| S109 | 2022-06-24 | Normal 180 Day Track |
| S108 | 2020-10-29 | 30-day Notice |
| S107 | 2020-05-05 | 30-day Notice |
| S106 | ||
| S105 | 2019-05-14 | 30-day Notice |
| S104 | 2019-05-03 | 30-day Notice |
| S103 | 2019-04-25 | 30-day Notice |
| S102 | 2019-03-28 | 30-day Notice |
| S101 | ||
| S100 | 2018-09-04 | 30-day Notice |
| S099 | 2018-06-18 | 30-day Notice |
| S098 | 2018-04-30 | 30-day Notice |
| S097 | 2018-02-12 | 30-day Notice |
| S096 | 2017-10-17 | 30-day Notice |
| S095 | 2017-09-27 | 30-day Notice |
| S094 | 2017-08-01 | 30-day Notice |
| S093 | 2017-07-03 | 30-day Notice |
| S092 | 2017-05-24 | 30-day Notice |
| S091 | 2017-04-14 | 30-day Notice |
| S090 | 2017-04-10 | 30-day Notice |
| S089 | 2017-03-27 | 30-day Notice |
| S088 | 2017-02-06 | 30-day Notice |
| S087 | 2017-01-27 | 30-day Notice |
| S086 | 2017-01-17 | 30-day Notice |
| S085 | 2016-12-20 | 30-day Notice |
| S084 | 2016-11-01 | 30-day Notice |
| S083 | 2016-07-15 | 30-day Notice |
| S082 | 2016-07-13 | Special (immediate Track) |
| S081 | 2016-04-11 | 30-day Notice |
| S080 | 2016-02-08 | 30-day Notice |
| S079 | 2015-09-21 | 30-day Notice |
| S078 | ||
| S077 | 2015-04-09 | 30-day Notice |
| S076 | 2015-04-03 | 30-day Notice |
| S075 | 2014-12-23 | 30-day Notice |
| S074 | 2014-07-15 | 30-day Notice |
| S073 | 2013-07-26 | 30-day Notice |
| S072 | 2013-04-02 | 30-day Notice |
| S071 | ||
| S070 | 2013-02-13 | 30-day Notice |
| S069 | 2013-02-05 | 30-day Notice |
| S068 | 2013-01-28 | 30-day Notice |
| S067 | 2012-11-13 | 30-day Notice |
| S066 | 2012-07-06 | 30-day Notice |
| S065 | 2012-04-12 | 30-day Notice |
| S064 | 2012-02-28 | 30-day Notice |
| S063 | 2011-11-23 | 30-day Notice |
| S062 | 2011-11-07 | 30-day Notice |
| S061 | 2011-09-19 | 135 Review Track For 30-day Notice |
| S060 | 2011-08-15 | 30-day Notice |
| S059 | 2011-05-23 | 30-day Notice |
| S058 | 2011-05-17 | 30-day Notice |
| S057 | 2011-05-16 | 30-day Notice |
| S056 | 2011-05-12 | 30-day Notice |
| S055 | 2011-04-22 | 30-day Notice |
| S054 | 2011-03-10 | 30-day Notice |
| S053 | 2011-01-18 | 30-day Notice |
| S052 | 2011-01-18 | 30-day Notice |
| S051 | ||
| S050 | 2010-10-08 | 30-day Notice |
| S049 | 2010-10-01 | 30-day Notice |
| S048 | 2010-09-29 | 135 Review Track For 30-day Notice |
| S047 | 2010-06-28 | 30-day Notice |
| S046 | 2010-04-02 | 30-day Notice |
| S045 | 2010-03-10 | 135 Review Track For 30-day Notice |
| S044 | 2010-03-08 | 135 Review Track For 30-day Notice |
| S043 | 2009-09-23 | 30-day Notice |
| S042 | 2009-06-22 | Real-time Process |
| S041 | 2009-04-20 | 30-day Notice |
| S040 | 2006-09-05 | Real-time Process |
| S039 | 2003-12-22 | Real-time Process |
| S038 | 2002-12-16 | Real-time Process |
| S037 | 2002-02-19 | Special (immediate Track) |
| S036 | 2001-06-29 | Real-time Process |
| S035 | 2001-01-29 | Normal 180 Day Track |
| S034 | 2000-11-03 | Normal 180 Day Track |
| S033 | 1999-04-01 | Real-time Process |
| S032 | 1999-03-01 | Real-time Process |
| S031 | 1997-07-03 | Real-time Process |
| S030 | 1997-05-02 | Real-time Process |
| S029 | 1996-07-18 | Normal 180 Day Track |
| S028 | 1996-02-06 | Normal 180 Day Track |
| S027 | 1993-05-14 | Normal 180 Day Track |
| S026 | 1992-10-16 | Normal 180 Day Track |
| S025 | 1990-09-21 | Normal 180 Day Track |
| S024 | 1990-06-05 | Normal 180 Day Track |
| S023 | ||
| S022 | 1989-07-20 | Normal 180 Day Track |
| S021 | 1989-07-20 | Normal 180 Day Track |
| S020 | 1989-07-20 | Normal 180 Day Track |
| S019 | 1988-03-14 | Normal 180 Day Track |
| S018 | 1987-09-15 | Special (immediate Track) |
| S017 | 1987-09-16 | Special (immediate Track) |
| S016 | 1987-05-18 | Normal 180 Day Track |
| S015 | 1986-07-23 | Normal 180 Day Track |
| S014 | 1986-03-26 | |
| S013 | 1985-09-11 | |
| S012 | ||
| S011 | 1985-02-25 | |
| S010 | 1984-12-10 | |
| S009 | 1983-12-21 | |
| S008 | 1983-07-15 | |
| S007 | 1983-03-24 | |
| S006 | 1982-12-27 | |
| S005 | 1982-07-07 | |
| S004 | 1982-04-08 | |
| S003 | 1981-03-05 | |
| S002 | ||
| S001 | 1979-08-28 |