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 a change in trade name for the biofinity energys aspheric lens and expanded powers for the biofinity xr toric and biofinity xr multifocal lenses. The devices, as modified, will be marketed under the trade names biofinity energys asphere, biofinity xr toric, and biofinity xr multifocal (comfilcon a) soft (hydrophilic) contact lenses forextended wear and are indicated for: biofinity energys asphere (comfilcon a) soft contact lenses are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20. 00 to +20. 00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2. 00 diopters or less that does not interfere with visual acuity. Biofinity xr toric (comfilcon a) soft contact lenses are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20. 00 to +20. 00 d and astigmatism corrections from -0. 25 to -5. 75 d. Biofinity xr multifocal (comfilcon a) lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) with emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes in powers from -20. 00 to +20. 00 d and with add powers from +0. 05 to +4. 00 d. The lenses may be worn by persons who exhibitastigmatism of 2. 00 d or less that does not interfere with visual acuity.
| Device | BIOFINITY ENERGYS ASPHERE, BIOFINITY XR TORIC, BIOFINITY XR MULTIFOCAL |
| Classification Name | Lenses, Soft Contact, Extended Wear |
| Generic Name | Lenses, Soft Contact, Extended Wear |
| Applicant | COOPERVISION MANUFACTURING, LTD. |
| Date Received | 2014-12-16 |
| Decision Date | 2015-03-11 |
| PMA | P080011 |
| Supplement | S035 |
| Product Code | LPM |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | COOPERVISION MANUFACTURING, LTD. 6140 Stoneridge Mall Road suite 500 pleasanton, CA 94588 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P080011 | Original Filing | |
| S153 | 2022-12-21 | 30-day Notice |
| S152 | 2022-11-29 | 30-day Notice |
| S151 | 2022-11-09 | 30-day Notice |
| S150 | 2022-10-25 | 30-day Notice |
| S149 | 2022-09-30 | 30-day Notice |
| S148 | 2022-07-21 | 30-day Notice |
| S147 | 2022-07-11 | 30-day Notice |
| S146 | 2022-04-27 | Real-time Process |
| S145 | 2022-04-06 | 30-day Notice |
| S144 | ||
| S143 | 2022-03-31 | 30-day Notice |
| S142 | ||
| S141 | ||
| S140 | 2022-03-17 | 30-day Notice |
| S139 | ||
| S138 | 2022-01-19 | 30-day Notice |
| S137 | 2021-12-09 | 30-day Notice |
| S136 | 2021-11-15 | 30-day Notice |
| S135 | ||
| S134 | 2021-10-28 | 30-day Notice |
| S133 | 2021-10-21 | 30-day Notice |
| S132 | 2021-10-13 | 30-day Notice |
| S131 | ||
| S130 | ||
| S129 | 2021-05-12 | 30-day Notice |
| S128 | 2021-04-26 | 30-day Notice |
| S127 | 2021-04-09 | 30-day Notice |
| S126 | 2021-03-24 | 30-day Notice |
| S125 | 2021-03-18 | 30-day Notice |
| S124 | 2021-03-11 | 30-day Notice |
| S123 | 2021-02-04 | 30-day Notice |
| S122 | 2020-12-28 | 30-day Notice |
| S121 | 2020-12-14 | 30-day Notice |
| S120 | ||
| S119 | 2020-10-20 | 30-day Notice |
| S118 | 2020-10-09 | 30-day Notice |
| S117 | 2020-09-10 | 30-day Notice |
| S116 | 2020-08-24 | 30-day Notice |
| S115 | 2020-08-20 | 30-day Notice |
| S114 | 2020-08-10 | 30-day Notice |
| S113 | 2020-07-30 | 30-day Notice |
| S112 | ||
| S111 | 2020-07-17 | 30-day Notice |
| S110 | ||
| S109 | 2020-07-14 | 30-day Notice |
| S108 | 2020-07-01 | 30-day Notice |
| S107 | 2020-06-29 | 30-day Notice |
| S106 | ||
| S105 | 2020-03-24 | 30-day Notice |
| S104 | 2020-03-04 | 30-day Notice |
| S103 | 2020-02-26 | 30-day Notice |
| S102 | 2020-02-13 | 30-day Notice |
| S101 | ||
| S100 | 2019-09-30 | Normal 180 Day Track |
| S099 | 2019-09-17 | 30-day Notice |
| S098 | ||
| S097 | 2019-08-13 | 30-day Notice |
| S096 | 2019-08-09 | 30-day Notice |
| S095 | 2019-07-12 | 30-day Notice |
| S094 | 2019-05-13 | 30-day Notice |
| S093 | 2019-05-02 | 30-day Notice |
| S092 | 2019-04-16 | 30-day Notice |
| S091 | 2019-03-11 | 30-day Notice |
| S090 | 2019-02-01 | 30-day Notice |
| S089 | 2019-01-10 | 30-day Notice |
| S088 | 2019-01-03 | 30-day Notice |
| S087 | ||
| S086 | 2018-12-17 | 30-day Notice |
| S085 | ||
| S084 | 2018-11-09 | 30-day Notice |
| S083 | 2018-11-01 | 30-day Notice |
| S082 | 2018-10-19 | Normal 180 Day Track No User Fee |
| S081 | 2018-09-25 | 30-day Notice |
| S080 | 2018-08-10 | 30-day Notice |
| S079 | 2018-08-09 | Normal 180 Day Track No User Fee |
| S078 | 2018-07-19 | 30-day Notice |
| S077 | 2018-07-12 | 30-day Notice |
| S076 | 2018-06-11 | 30-day Notice |
| S075 | 2018-05-09 | 30-day Notice |
| S074 | 2018-03-16 | 135 Review Track For 30-day Notice |
| S073 | 2018-03-14 | 30-day Notice |
| S072 | 2018-02-27 | 30-day Notice |
| S071 | 2018-02-14 | 30-day Notice |
| S070 | 2018-01-29 | 30-day Notice |
| S069 | 2018-01-16 | 135 Review Track For 30-day Notice |
| S068 | 2018-01-11 | Normal 180 Day Track No User Fee |
| S067 | 2017-12-26 | Normal 180 Day Track No User Fee |
| S066 | 2017-12-19 | Normal 180 Day Track No User Fee |
| S065 | 2017-12-04 | 30-day Notice |
| S064 | 2017-11-17 | 30-day Notice |
| S063 | 2017-10-26 | 30-day Notice |
| S062 | 2017-10-23 | 30-day Notice |
| S061 | 2017-07-14 | 30-day Notice |
| S060 | 2017-05-26 | 30-day Notice |
| S059 | 2017-05-16 | 30-day Notice |
| S058 | 2017-03-27 | Normal 180 Day Track No User Fee |
| S057 | 2017-03-24 | 30-day Notice |
| S056 | 2017-03-13 | 30-day Notice |
| S055 | 2017-02-02 | 30-day Notice |
| S054 | 2017-01-10 | 30-day Notice |
| S053 | 2017-01-08 | 30-day Notice |
| S052 | 2016-12-06 | 30-day Notice |
| S051 | 2016-11-03 | 30-day Notice |
| S050 | 2016-10-13 | 30-day Notice |
| S049 | 2016-09-27 | Normal 180 Day Track No User Fee |
| S048 | 2016-09-19 | 30-day Notice |
| S047 | 2016-09-19 | 30-day Notice |
| S046 | 2016-09-13 | 30-day Notice |
| S045 | 2016-05-16 | 30-day Notice |
| S044 | 2016-05-16 | 30-day Notice |
| S043 | ||
| S042 | 2016-03-14 | 30-day Notice |
| S041 | 2016-02-29 | 30-day Notice |
| S040 | 2015-10-09 | 30-day Notice |
| S039 | 2015-10-07 | 30-day Notice |
| S038 | 2015-07-02 | 30-day Notice |
| S037 | 2015-04-14 | 30-day Notice |
| S036 | 2015-03-12 | 30-day Notice |
| S035 | 2014-12-16 | Normal 180 Day Track |
| S034 | 2014-12-15 | 30-day Notice |
| S033 | 2014-11-28 | 30-day Notice |
| S032 | 2014-11-03 | 30-day Notice |
| S031 | 2014-08-08 | 30-day Notice |
| S030 | 2014-02-27 | 135 Review Track For 30-day Notice |
| S029 | 2014-02-03 | Normal 180 Day Track No User Fee |
| S028 | 2013-11-13 | 135 Review Track For 30-day Notice |
| S027 | 2013-08-12 | 30-day Notice |
| S026 | 2013-07-03 | 30-day Notice |
| S025 | 2013-07-01 | 30-day Notice |
| S024 | 2013-05-13 | Normal 180 Day Track No User Fee |
| S023 | 2013-04-09 | 30-day Notice |
| S022 | 2012-12-20 | 30-day Notice |
| S021 | 2012-12-19 | 30-day Notice |
| S020 | 2012-12-12 | 30-day Notice |
| S019 | 2012-11-07 | 30-day Notice |
| S018 | 2012-09-17 | Normal 180 Day Track No User Fee |
| S017 | 2012-08-28 | 30-day Notice |
| S016 | 2012-06-25 | 30-day Notice |
| S015 | 2012-06-21 | Normal 180 Day Track No User Fee |
| S014 | 2012-06-15 | 30-day Notice |
| S013 | 2012-06-05 | 30-day Notice |
| S012 | 2012-05-22 | 30-day Notice |
| S011 | 2012-03-30 | 30-day Notice |
| S010 | 2012-02-01 | 30-day Notice |
| S009 | 2012-01-26 | Special (immediate Track) |
| S008 | 2012-01-24 | 30-day Notice |
| S007 | 2012-01-24 | 30-day Notice |
| S006 | 2011-11-01 | 30-day Notice |
| S005 | 2011-08-11 | Normal 180 Day Track No User Fee |
| S004 | 2011-02-24 | Normal 180 Day Track No User Fee |
| S003 | 2010-03-12 | 30-day Notice |
| S002 | 2010-01-19 | 30-day Notice |
| S001 | 2009-02-27 | 30-day Notice |