PMA
N18033: ACUVUE CONTACT LENS
FDA PMA · Lenses, soft contact, extended wear · Vistakon, Johnson & Johnson Vision Products, Inc.
Key facts
| PMA number | N18033 |
|---|---|
| Trade name | ACUVUE CONTACT LENS |
| Generic name | Lenses, soft contact, extended wear |
| Applicant | Vistakon, Johnson & Johnson Vision Products, Inc. |
| Owner/operator | Johnson & Johnson Vision Care, Inc. |
| Product code | LPM |
| Approval date | Mar 18, 1980 |
| Establishment registration | 1057985 |
| FEI number | 1000222023 |
At a glance
- 100–999 Supplements
- Apr 17, 2026 Latest supplement decision
- No Withdrawn
- No 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: