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.
Modifications to enable the automation of the nozzle coating process at alcon laboratories in ireland as part of the manufacturing process for the acrysof® iq aspheric iol with ultrasert® preloaded delivery system, model au00t0.
| Device | AcrySof Intraocular Lenses and Delivery System |
| Generic Name | Intraocular Lens |
| Applicant | ALCON LABORATORIES, INC. |
| Date Received | 2020-03-30 |
| Decision Date | 2020-04-23 |
| PMA | P930014 |
| Supplement | S129 |
| Product Code | HQL |
| Advisory Committee | Ophthalmic |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ALCON LABORATORIES, INC. 6201 South Freeway Dr. fort Worth, TX 76134 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P930014 | Original Filing | |
| S144 | 2022-11-22 | 30-day Notice |
| S143 | 2022-04-22 | 30-day Notice |
| S142 | 2022-03-01 | 30-day Notice |
| S141 | ||
| S140 | 2021-11-23 | 30-day Notice |
| S139 | 2021-07-26 | 30-day Notice |
| S138 | ||
| S137 | 2021-06-16 | 30-day Notice |
| S136 | 2021-03-26 | Real-time Process |
| S135 | 2021-03-26 | 30-day Notice |
| S134 | 2020-11-25 | 30-day Notice |
| S133 | 2020-09-10 | 30-day Notice |
| S132 | ||
| S131 | ||
| S130 | 2020-04-06 | 30-day Notice |
| S129 | 2020-03-30 | 30-day Notice |
| S128 | 2019-09-11 | 30-day Notice |
| S127 | 2019-08-30 | 30-day Notice |
| S126 | ||
| S125 | 2019-07-22 | 30-day Notice |
| S124 | ||
| S123 | 2019-07-05 | 30-day Notice |
| S122 | 2019-03-25 | 30-day Notice |
| S121 | 2019-03-25 | 30-day Notice |
| S120 | ||
| S119 | 2019-03-01 | 30-day Notice |
| S118 | 2018-11-20 | 30-day Notice |
| S117 | 2018-11-07 | 30-day Notice |
| S116 | 2018-10-05 | 30-day Notice |
| S115 | 2018-09-12 | 30-day Notice |
| S114 | 2018-09-10 | 30-day Notice |
| S113 | 2018-09-07 | 30-day Notice |
| S112 | 2018-05-02 | Real-time Process |
| S111 | 2018-03-16 | 30-day Notice |
| S110 | 2018-01-29 | Real-time Process |
| S109 | 2017-12-21 | 30-day Notice |
| S108 | 2017-11-28 | 30-day Notice |
| S107 | 2017-11-21 | 30-day Notice |
| S106 | 2017-11-13 | 30-day Notice |
| S105 | 2017-09-08 | 30-day Notice |
| S104 | 2017-06-15 | 135 Review Track For 30-day Notice |
| S103 | 2017-06-06 | Real-time Process |
| S102 | 2017-04-21 | Real-time Process |
| S101 | 2017-04-06 | 30-day Notice |
| S100 | ||
| S099 | 2016-12-02 | Real-time Process |
| S098 | 2016-11-30 | 30-day Notice |
| S097 | 2016-11-16 | Normal 180 Day Track |
| S096 | 2016-10-26 | Real-time Process |
| S095 | 2016-08-03 | 30-day Notice |
| S094 | 2016-07-29 | 135 Review Track For 30-day Notice |
| S093 | 2016-07-21 | 30-day Notice |
| S092 | 2016-07-20 | Real-time Process |
| S091 | 2016-05-13 | Real-time Process |
| S090 | 2016-04-08 | 30-day Notice |
| S089 | 2016-03-09 | 30-day Notice |
| S088 | 2015-12-09 | 30-day Notice |
| S087 | 2015-12-07 | 30-day Notice |
| S086 | 2015-10-21 | 30-day Notice |
| S085 | 2015-09-08 | Real-time Process |
| S084 | 2015-08-07 | Real-time Process |
| S083 | 2015-07-27 | 30-day Notice |
| S082 | 2015-07-20 | Normal 180 Day Track No User Fee |
| S081 | 2015-06-18 | 30-day Notice |
| S080 | 2015-05-22 | Real-time Process |
| S079 | 2015-04-06 | 30-day Notice |
| S078 | 2015-02-12 | 30-day Notice |
| S077 | 2014-12-19 | Normal 180 Day Track No User Fee |
| S076 | 2014-12-16 | Real-time Process |
| S075 | 2014-09-26 | 30-day Notice |
| S074 | 2014-07-24 | Normal 180 Day Track No User Fee |
| S073 | 2014-06-19 | 30-day Notice |
| S072 | 2013-12-19 | 30-day Notice |
| S071 | 2013-12-19 | 30-day Notice |
| S070 | 2013-12-11 | 30-day Notice |
| S069 | 2013-07-31 | Normal 180 Day Track |
| S068 | 2013-04-22 | 30-day Notice |
| S067 | 2013-03-20 | 30-day Notice |
| S066 | 2012-12-26 | Normal 180 Day Track No User Fee |
| S065 | 2012-12-20 | 30-day Notice |
| S064 | 2012-10-01 | 30-day Notice |
| S063 | 2012-07-20 | 30-day Notice |
| S062 | 2012-05-29 | 30-day Notice |
| S061 | 2012-03-12 | 30-day Notice |
| S060 | 2012-03-06 | Real-time Process |
| S059 | 2012-02-13 | 30-day Notice |
| S058 | 2012-02-06 | Normal 180 Day Track No User Fee |
| S057 | 2012-01-17 | 30-day Notice |
| S056 | 2011-09-02 | 30-day Notice |
| S055 | 2011-09-01 | Real-time Process |
| S054 | 2011-08-29 | 30-day Notice |
| S053 | 2011-07-05 | 30-day Notice |
| S052 | 2011-07-01 | 30-day Notice |
| S051 | 2011-06-30 | 30-day Notice |
| S050 | 2011-06-24 | 30-day Notice |
| S049 | 2011-06-09 | 30-day Notice |
| S048 | 2011-06-02 | Normal 180 Day Track No User Fee |
| S047 | 2011-02-10 | 30-day Notice |
| S046 | 2010-10-19 | 30-day Notice |
| S045 | 2010-08-31 | Panel Track |
| S044 | 2010-08-25 | 30-day Notice |
| S043 | 2010-08-18 | 30-day Notice |
| S042 | 2010-08-10 | 30-day Notice |
| S041 | 2010-05-03 | 30-day Notice |
| S040 | 2010-05-03 | 30-day Notice |
| S039 | 2010-02-02 | Real-time Process |
| S038 | 2010-01-19 | 30-day Notice |
| S037 | 2009-12-24 | 30-day Notice |
| S036 | 2009-10-19 | 30-day Notice |
| S035 | 2009-06-30 | 30-day Notice |
| S034 | 2009-06-18 | 135 Review Track For 30-day Notice |
| S033 | 2009-05-11 | 30-day Notice |
| S032 | 2009-05-11 | 30-day Notice |
| S031 | 2009-02-20 | 30-day Notice |
| S030 | 2009-01-06 | 30-day Notice |
| S029 | 2008-12-12 | Real-time Process |
| S028 | 2008-09-23 | 30-day Notice |
| S027 | 2008-07-31 | 30-day Notice |
| S026 | 2008-07-28 | 30-day Notice |
| S025 | 2008-05-22 | 135 Review Track For 30-day Notice |
| S024 | 2008-04-21 | Real-time Process |
| S023 | 2008-01-15 | Real-time Process |
| S022 | 2007-10-31 | 30-day Notice |
| S021 | ||
| S020 | 2007-04-10 | 135 Review Track For 30-day Notice |
| S019 | 2006-12-19 | Normal 180 Day Track No User Fee |
| S018 | 2006-07-24 | 30-day Notice |
| S017 | 2006-03-02 | Normal 180 Day Track |
| S016 | 2005-11-14 | Real-time Process |
| S015 | 2005-03-18 | Panel Track |
| S014 | 2004-04-16 | Real-time Process |
| S013 | 2003-11-21 | Real-time Process |
| S012 | 2003-08-05 | Special (immediate Track) |
| S011 | 2003-07-25 | Real-time Process |
| S010 | 2002-09-11 | Normal 180 Day Track |
| S009 | 2001-12-26 | Normal 180 Day Track |
| S008 | 2000-09-27 | 30-day Notice |
| S007 | ||
| S006 | 1998-12-14 | Normal 180 Day Track |
| S005 | 1997-06-23 | Normal 180 Day Track |
| S004 | 1996-10-24 | Normal 180 Day Track |
| S003 | 1996-08-08 | Normal 180 Day Track |
| S002 | 1995-09-27 | Normal 180 Day Track |
| S001 | 1995-01-31 | Normal 180 Day Track |