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 modifictions to soflens(r) (polymacon) contact lenses including the following lens types (series): 03, 04, occasions(tm) multifocal, optima(tm) 38, optima(tm) 38/sp, u3, u4, sofspin(tm), h03, h04, b3, b4, p. A. 1, f3, h3, h4, n, naturaltine, optima(tm) fw, and seequence(tm). Modifications include: 1)removing the replacement system descriptors from labeling specific to the optima(tm) fw contact lenses; 2)adding monovisio fitting technique for all bausch & lomb soflens(r) (polymacon) contact lenses in this supplement;3)consolidating info in six fitting guides into 3 fitting guides for soflens(r), naturaltint(r), occasions(tm) multifocal, and p. A. 1 contact lenses; 4)consolidating 2 patient info booklets (1 for frequent replacement use and 1 for disposable use) for seequence(tm) (polymacon) visibility tinted contact lenses into a single patient info booklet (this modification results in deletion of the disposable wear indication); 5)formatting changes to package inserts, fitting fuides & patient info booklets to bring labeling up-to-date with recommendations in cdrh's current labeling guidance; and 6)separating the therapeutic indiation from the cosmetic labeling included in this supplement.
| Device | SOFLENS (POLYMACON) CONTACT LENSES |
| Classification Name | Lenses, Soft Contact, Extended Wear |
| Generic Name | Lenses, Soft Contact, Extended Wear |
| Applicant | Bausch & Lomb, Inc. |
| Date Received | 1996-10-01 |
| Decision Date | 1997-01-30 |
| PMA | N16895 |
| Supplement | S084 |
| Product Code | LPM |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Bausch & Lomb, Inc. 1400 North Goodman St. rochester, NY 14609-3547 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| N16895 | Original Filing | |
| S105 | 2022-02-18 | 30-day Notice |
| S104 | ||
| S103 | 2020-03-20 | 30-day Notice |
| S102 | 2018-07-05 | 30-day Notice |
| S101 | 2018-05-15 | 30-day Notice |
| S100 | 2017-07-14 | 30-day Notice |
| S099 | 2016-07-21 | Real-time Process |
| S098 | 2016-07-15 | 30-day Notice |
| S097 | 2015-08-03 | 30-day Notice |
| S096 | 2014-09-02 | 30-day Notice |
| S095 | 2014-01-03 | 135 Review Track For 30-day Notice |
| S094 | 2011-10-19 | 135 Review Track For 30-day Notice |
| S093 | 2011-02-08 | 30-day Notice |
| S092 | 2011-01-10 | 30-day Notice |
| S091 | 2008-11-12 | Real-time Process |
| S090 | 2008-09-24 | Real-time Process |
| S089 | 2005-10-18 | Normal 180 Day Track No User Fee |
| S088 | 2001-01-09 | Normal 180 Day Track |
| S087 | 1999-11-16 | Normal 180 Day Track |
| S086 | 1999-10-26 | 30-day Notice |
| S085 | 1997-08-07 | Normal 180 Day Track |
| S084 | 1996-10-01 | Normal 180 Day Track |
| S083 | 1994-11-18 | Normal 180 Day Track |
| S082 | 1993-08-12 | Normal 180 Day Track |
| S081 | 1992-12-01 | Normal 180 Day Track |
| S080 | 1991-11-18 | Normal 180 Day Track |
| S079 | 1991-08-27 | Normal 180 Day Track |
| S078 | ||
| S077 | 1991-06-18 | Normal 180 Day Track |
| S076 | 1991-06-05 | Normal 180 Day Track |
| S075 | 1991-05-10 | Normal 180 Day Track |
| S074 | 1991-05-02 | Normal 180 Day Track |
| S073 | ||
| S072 | ||
| S071 | 1990-11-05 | Normal 180 Day Track |
| S070 | 1990-11-05 | Normal 180 Day Track |
| S069 | 1990-08-23 | Normal 180 Day Track |
| S068 | 1990-07-03 | Normal 180 Day Track |
| S067 | 1990-03-08 | Normal 180 Day Track |
| S066 | 1989-08-29 | Normal 180 Day Track |
| S065 | ||
| S064 | 1989-08-28 | Normal 180 Day Track |
| S063 | 1989-07-24 | Normal 180 Day Track |
| S062 | 1989-07-24 | Normal 180 Day Track |
| S061 | 1989-07-21 | Normal 180 Day Track |
| S060 | 1989-05-25 | Normal 180 Day Track |
| S059 | 1989-01-03 | Normal 180 Day Track |
| S058 | 1988-12-09 | Normal 180 Day Track |
| S057 | 1988-12-09 | Normal 180 Day Track |
| S056 | 1988-12-08 | Normal 180 Day Track |
| S055 | 1988-12-06 | Normal 180 Day Track |
| S054 | 1988-09-20 | Normal 180 Day Track |
| S053 | 1988-08-05 | Special (immediate Track) |
| S052 | 1988-07-29 | Normal 180 Day Track |
| S051 | 1987-10-15 | Normal 180 Day Track |
| S050 | 1987-09-02 | Normal 180 Day Track |
| S049 | 1987-08-06 | 30-Day Supplement |
| S048 | 1987-05-15 | Normal 180 Day Track |
| S047 | 1987-02-02 | 30-Day Supplement |
| S046 | 1987-01-21 | Normal 180 Day Track |
| S045 | 1987-01-05 | Normal 180 Day Track |
| S044 | 1986-08-20 | Normal 180 Day Track |
| S043 | 1986-04-22 | |
| S042 | 1986-03-18 | Normal 180 Day Track |
| S041 | 1986-03-18 | |
| S040 | 1985-08-30 | |
| S039 | ||
| S038 | 1985-03-20 | |
| S037 | 1985-02-07 | |
| S036 | 1984-07-23 | |
| S035 | ||
| S034 | ||
| S033 | 1984-06-22 | |
| S032 | ||
| S031 | 1984-05-08 | |
| S030 | ||
| S029 | 1983-11-14 | |
| S028 | 1983-04-13 | |
| S027 | 1982-12-27 | |
| S026 | 1982-12-16 | |
| S025 | 1982-08-25 | |
| S024 | 1982-07-20 | |
| S023 | 1982-05-20 | |
| S022 | ||
| S021 | 1982-02-19 | |
| S020 | 1981-12-17 | |
| S019 | 1981-10-19 | |
| S018 | 1981-07-29 | |
| S017 | 1981-05-05 | |
| S016 | ||
| S015 | 1980-12-30 | |
| S014 | 1980-09-26 | |
| S013 | 1980-08-25 | |
| S012 | 1980-08-25 | |
| S011 | 1980-08-15 | |
| S010 | 1980-08-01 | |
| S009 | 1980-05-05 | |
| S008 | 1980-04-21 | |
| S007 | 1980-02-05 | |
| S006 | 1979-08-02 | |
| S005 | 1979-07-13 | |
| S004 | 1979-06-06 | |
| S003 | 1979-02-15 | |
| S002 | 1978-12-11 | |
| S001 | 1979-03-02 | Normal 180 Day Track |