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 1) the establishment of separate labeling for the therapeutic use indication; and, 2) combining the package insert and professional fitting guide into a single reference intended for the eye care practitioner. The device, as modified, will be marketed under the trade names soflens(r) (polymacon) contact lenses (plano t) and bausch & lomb optima(r) fw (polymacon) visibility tinted contact lenses. The lenses are indicated for use in the treatment and management of acute and chronic corneal pathologies such as bullous keratopathy, corneal ulcers and erosion, dry eyes, keratitis protection of cornea during and after surgery, accidental or surgical trauma, and entropion. When prescribed for therapeutic use, the soflens(r) (polymacon) contact lenses (plano t and optima(r) fw) may be worn for daily or extended wearing periods. The eye care practitioner should recommend either single-use disposable wear or a schedule of periodic replacement, and should provide instructions for cleaning, disinfection, and replacement of the lenses. The lenses may be disinfected using a chemical disinfection system. The lens should be inserted and removed only as the eye care practitioner has instructed.
| 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 | 1999-11-16 |
| Decision Date | 2001-03-26 |
| PMA | N16895 |
| Supplement | S087 |
| 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 |