PMA
P080010: TECNIS MULTIFOCAL FOLDABLE POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)
FDA PMA · Lens, multifocal intraocular · Johnson & Johnson Surgical Vision, Inc.
Key facts
| PMA number | P080010 |
|---|---|
| Trade name | TECNIS MULTIFOCAL FOLDABLE POSTERIOR CHAMBER INTRAOCULAR LENS (IOL) |
| Generic name | Lens, multifocal intraocular |
| Applicant | Johnson & Johnson Surgical Vision, Inc. |
| Owner/operator | Johnson & Johnson Surgical Vision, Inc. |
| Product code | MFK |
| Approval date | Jan 16, 2009 |
| Docket number | 09M-0034 |
| Notice date | Jan 27, 2009 |
| Establishment registration | 3012236936 |
| FEI number | 3012236936 |
At a glance
- 10–99 Supplements
- Jun 3, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- None UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: