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 changes in manufacturing with installation of new equipment and process accessories for machining, tumbling, assembly, and inspection for 3-piece intraocular lens models ct lucia 202 and ct lucia 602.
| Device | Zeiss 3-piece Hydrophobic Acrylic Intraocular lens (IOL) |
| Generic Name | Intraocular Lens |
| Applicant | Carl Zeiss Meditec Production LLC |
| Date Received | 2020-08-31 |
| Decision Date | 2021-05-13 |
| PMA | P100016 |
| Supplement | S007 |
| Product Code | HQL |
| Advisory Committee | Ophthalmic |
| Supplement Type | 135 Review Track For 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 |
| 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 |