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 change in product name from aaris® ec-3 and aaris® ec-3 pal to ct lucia 202 and ct lucia 602 respectively; minor product labeling changes to include the unit container box, adhesive label, instructions for use and patient card; and a new contact/manufacturing address.
| Device | CT LUCIA 202 IOL and CT LUCIA 602 IOL |
| Classification Name | Intraocular Lens |
| Generic Name | Intraocular Lens |
| Applicant | Carl Zeiss Meditec Production LLC |
| Date Received | 2017-05-22 |
| Decision Date | 2017-08-09 |
| PMA | P100016 |
| Supplement | S004 |
| Product Code | HQL |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 |