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 to expand dioptric-power range to 6. 0 d - 34. 0 d for clareon panoptix trifocal hydrophobic iol (cnwtt0), clareon panoptix trifocal uv absorbing iol (ccwtt0), and clareon panoptix trifocal hydrophobic iol models cnwtt3-cnwtt6, as well as approval for clareon panoptix toric trifocal hydrophobic iol with the autonome automated preloaded delivery device (cnatt3-cnatt6)
| Device | Clareon PanOptix Trifocal Hydrophobic IOL, Clareon PanOptix Trifocal UV Absorbing IOL, Clareon PanOptix Trifocal Hydroph |
| Generic Name | Lens, Multifocal Intraocular |
| Applicant | Alcon Research, Ltd. |
| Date Received | 2020-12-14 |
| Decision Date | 2021-03-15 |
| PMA | P190018 |
| Supplement | S009 |
| Advisory Committee | Ophthalmic |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| 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 | |
| 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 |