This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the focus night and day (lotrafilcon a) soft contact lenses. The device is indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with up to approximately 1. 50 diopters of astigmatism. The lenses may be prescribed for extended wear for 1 to 7 days between removals for cleaning and disinfection or disposal of the lens, as recommended by the eye care professional. Lenses should be replaced every month and when removed between replacement times must be cleaned and disinfected with a chemical, not heat, disinfection system before reinsertion.
| Device | FOCUS NIGHT & DAY (LOTRAFILCON A) SOFT CONTACT LENSES |
| Generic Name | Lenses, Soft Contact, Extended Wear |
| Applicant | Alcon Laboratories, Inc. |
| Date Received | 2000-07-18 |
| Decision Date | 2001-10-12 |
| Notice Date | 2001-10-19 |
| PMA | P000030 |
| Supplement | S |
| Product Code | LPM |
| Docket Number | 01M-0480 |
| Advisory Committee | Ophthalmic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Alcon Laboratories, Inc. 6201 South Freeway fort Worth, TX 76134-2099 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P000030 | Original Filing | |
| S003 | 2016-06-01 | 30-day Notice |
| S002 | 2016-02-26 | 30-day Notice |
| S001 | 2016-02-16 | 30-day Notice |