Approval for the bausch + lomb ultra (samfilcon a) contact lenses. These devices are indicated for:single vision spherical (svs) vision correctionthe bausch + lomb ultra (samfilcon a) contact lens is indicated for extended wear for up to 7 days between removals for cleaning and disinfection or disposal of the lens, as recommended by the eye care practitioner. The lens is indicated for the correction of refractive ametropia (myopia and hyperopia) in aphakic and/or not-aphakic persons with non-diseased eyes, exhibiting astigmatism of 2. 00 diopters or less, that does not interfere with visual acuity. Presbyopia vision correctionthe bausch + lomb ultra (samfilcon a) contact lens for presbyopia is indicated for extended wear for up to 7 days between removals for cleaning and disinfection or disposal of the lens, as recommended by the eye care practitioner. The lens is indicated for the correction of refractive ametropia (myopia, hyperopia and astigmatism) and presbyopia in aphakic and/or not-aphakic persons with non-diseased eyes, exhibiting astigmatism of 2. 00 diopters or less, that does not interfere with visual acuity. The lens may be prescribed for add powers ranging from +0. 75d to +5. 00d. Astigmatism vision correctionthe bausch + lomb ultra (samfilcon a) contact lens for astigmatism is indicated for extended wear for up to 7 days between removals for cleaning and disinfection or disposal of the lens, as recommended by the eye care practitioner. The lens is indicated for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or not-aphakic persons with non-diseased eyes, exhibiting astigmatism up to 5. 00 diopters.
| Device | Bausch + Lomb Ultra (samfilcon A) Contact Lenses |
| Classification Name | Lenses, Soft Contact, Extended Wear |
| Generic Name | Lenses, Soft Contact, Extended Wear |
| Applicant | Bausch And Lomb, Inc. |
| Date Received | 2017-11-01 |
| Decision Date | 2018-04-30 |
| Notice Date | 2018-05-14 |
| PMA | P170035 |
| Supplement | S |
| Product Code | LPM |
| Docket Number | 18M-1791 |
| Advisory Committee | Ophthalmic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Bausch And Lomb, Inc. 1400 North Goodman Street rochester, NY 14609 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P170035 | Original Filing | |
| S017 | 2022-05-04 | 30-day Notice |
| S016 | 2022-02-22 | 30-day Notice |
| S015 | 2021-12-15 | 30-day Notice |
| S014 | ||
| S013 | 2021-06-03 | Real-time Process |
| S012 | 2021-03-12 | 30-day Notice |
| S011 | 2020-10-30 | 30-day Notice |
| S010 | 2020-09-29 | 30-day Notice |
| S009 | 2020-09-02 | 30-day Notice |
| S008 | 2020-06-18 | 30-day Notice |
| S007 | 2019-11-20 | 30-day Notice |
| S006 | 2019-08-14 | 30-day Notice |
| S005 | ||
| S004 | 2019-06-14 | 30-day Notice |
| S003 | 2019-02-04 | Normal 180 Day Track |
| S002 | ||
| S001 |