PMA supplement
P980040 S176: TECNIS PureSee IOL, Model DEN00V TECNIS PureSee Toric II IOLs, Model DET150, DET225, DET300, DET375
FDA PMA supplement · Panel Track · Johnson & Johnson Surgical Vision, Inc.
Key facts
| Original PMA | P980040 |
|---|---|
| Supplement number | S176 |
| Supplement type | Panel Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | TECNIS PureSee IOL, Model DEN00V TECNIS PureSee Toric II IOLs, Model DET150, DET225, DET300, DET375 |
| Generic name | Intraocular lens |
| Applicant | Johnson & Johnson Surgical Vision, Inc. |
| Product code | HQL |
| Received date | Jul 31, 2025 |
| Decision date | Mar 11, 2026 |
| Docket number | 26M-2542 |
| Notice date | Mar 12, 2026 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: