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 toric design with an extended wear indication from 1 to 7 days between removals for the above referenced device. The device, as modified, will be marketed under the trade name bausch & lomb soflens66 toric (alphafilcona) visibility tinted contact lenses and is indicated for extended wear from 1 to 7 days between removals, for cleaning and disinfection or disposal of the lens, as recommended by the eye care professional. The lens is indicated for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in not-aphakic persons with non-diseased eyes, exhibiting astigmatism of up to 5. 00 diopters (d) that does not interfere with visual acuity. The lens may be prescribed for frequent/planned replacement wear or disposable wear in spherical powers ranging from +6. 00 d to -9. 00d when prescribed for use to 7 days of extended wear.
| Device | SOFTLENS66 TORIC (ALPHAFILCON A)VISIBILITY TINTED CONTACT LENSES |
| Generic Name | Lenses, Soft Contact, Extended Wear |
| Applicant | Bausch & Lomb, Inc. |
| Date Received | 2003-03-03 |
| Decision Date | 2003-04-04 |
| PMA | P960022 |
| Supplement | S003 |
| Advisory Committee | Ophthalmic |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Bausch & Lomb, Inc. 1400 North Goodman St. rochester, NY 14609-3547 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P960022 | Original Filing | |
| S012 | 2020-03-20 | 30-day Notice |
| S011 | 2015-09-29 | 30-day Notice |
| S010 | 2013-10-17 | 30-day Notice |
| S009 | 2011-10-19 | 135 Review Track For 30-day Notice |
| S008 | 2011-03-03 | 30-day Notice |
| S007 | 2010-11-15 | Normal 180 Day Track No User Fee |
| S006 | 2010-05-17 | 30-day Notice |
| S005 | 2008-09-24 | Real-time Process |
| S004 | 2004-02-06 | 30-day Notice |
| S003 | 2003-03-03 | Real-time Process |
| S002 | 2001-01-09 | Normal 180 Day Track |
| S001 | 1997-08-07 | Normal 180 Day Track |