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.
Revision of internal procedures to harmonize the nomenclature for identifying the tooling used to manufacture approved contact lenses at the johor and atlanta manufacturing facilities; and development and implementation of a plan to validate and verify the fabrication of lotrafilcon b toric optical tools at the johor manufacturing facility.
| Device | FOCUS NIGHT & DAY (LOTRAFILCON A) SOFT CONTACT LENSES |
| Generic Name | Lenses, Soft Contact, Extended Wear |
| Applicant | Alcon Laboratories, Inc. |
| Date Received | 2016-02-16 |
| Decision Date | 2016-03-14 |
| PMA | P000030 |
| Supplement | S001 |
| Product Code | LPM |
| Advisory Committee | Ophthalmic |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Alcon Laboratories, Inc. 6201 South Freeway fort Worth, TX 76134-2099 |
| 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 |