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 new manufacturing facilities located at alcon research, llc, aodc-south, 6065 kyle lane, huntington, wv 25702 and alcon research, llc, aodc-north, 2 vision lane, lesage, wv 25537
| Device | Clareon Aspheric Hydrophobic lOL; Clareon PanOptix Hydrophobic lOL; and Clareon Toric Aspheric Hydrophobic lOL |
| Generic Name | Intraocular Lens |
| Applicant | Alcon Research, Ltd. |
| Date Received | 2021-02-22 |
| Decision Date | 2021-04-23 |
| PMA | P190018 |
| Supplement | S010 |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Alcon Research, Ltd. 6201 South Freeway, Tc-467 forth Worth, TX 76134 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P190018 | Original Filing | |
| S021 | 2022-11-22 | 30-day Notice |
| S020 | 2022-04-22 | 30-day Notice |
| S019 | 2022-04-06 | 30-day Notice |
| S018 | ||
| S017 | 2021-12-02 | 30-day Notice |
| S016 | 2021-11-30 | 30-day Notice |
| S015 | 2021-11-23 | 30-day Notice |
| S014 | 2021-11-05 | 30-day Notice |
| S013 | ||
| S012 | ||
| S011 | 2021-03-26 | 30-day Notice |
| S010 | 2021-02-22 | Normal 180 Day Track No User Fee |
| S009 | 2020-12-14 | Real-time Process |
| S008 | 2020-10-30 | 30-day Notice |
| S007 | 2020-10-16 | 30-day Notice |
| S006 | 2020-08-31 | 30-day Notice |
| S005 | ||
| S004 | 2020-05-19 | 30-day Notice |
| S003 | ||
| S002 | ||
| S001 |