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.
To reduce clareon intraocular lenses (iols) dimensional inspection from 100% to a sampling plan for non-toric models
| Device | Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon PanOptix Hydrophobic Acrylic IOL |
| Generic Name | Intraocular Lens |
| Applicant | Alcon Research, Ltd. |
| Date Received | 2021-11-05 |
| Decision Date | 2021-12-01 |
| PMA | P190018 |
| Supplement | S014 |
| 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 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 |