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.
A change in the microbiological test method for determination of pre-sterilization bioburden, and a change in the organism used to determine the bioburden enumeration correction factor
| Device | Clareon Aspheric Hydrophobic Acrylic IOL, Clareon Aspheric Hydrophobic Acrylic IOL with the AutonoMe Preloaded Delivery |
| Generic Name | Intraocular Lens |
| Applicant | Alcon Research, Ltd. |
| Date Received | 2021-11-23 |
| Decision Date | 2021-12-21 |
| PMA | P190018 |
| Supplement | S015 |
| 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 |