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.
| Device | CT LUCIA Intraocular Lens (IOL) |
| Generic Name | Intraocular Lens |
| Applicant | Carl Zeiss Meditec Production LLC1040 South Vintage Avenue, Bldg. Aontario, CA 91761-3631 PMA NumberP100016 Supplement NumberS015 Date Received12/09/2022 Decision Date01/05/2023 Product Code HQL Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-12-09 |
| Decision Date | 2023-01-05 |
| PMA | P100016 |
| Supplement | S015 |
| Product Code | HQL |
| Advisory Committee | Ophthalmic |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Carl Zeiss Meditec Production LLC 1040 South Vintage Avenue, Bldg. A ontario, CA 91761-3631 PMA NumberP100016 Supplement NumberS015 Date Received12/09/2022 Decision Date01/05/2023 Product Code HQL Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement changing To An Automated Extraction System Used In Hydrophobic Button Production Of CT Lucia 602, CT Lucia 202, And CT Lucia 611P Intraocular Lens |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P100016 | Original Filing | |
| S015 | 2022-12-09 | 30-day Notice |
| S014 | 2022-04-26 | 30-day Notice |
| S013 | 2022-03-25 | 30-day Notice |
| S012 | 2022-03-03 | 30-day Notice |
| S011 | ||
| S010 | ||
| S009 | ||
| S008 | 2020-09-08 | Normal 180 Day Track |
| S007 | 2020-08-31 | 135 Review Track For 30-day Notice |
| S006 | 2018-08-24 | 30-day Notice |
| S005 | 2018-02-08 | 30-day Notice |
| S004 | 2017-05-22 | Normal 180 Day Track No User Fee |
| S003 | 2017-03-24 | Special (immediate Track) |
| S002 | 2014-12-18 | Normal 180 Day Track No User Fee |
| S001 | 2013-02-19 | Normal 180 Day Track No User Fee |