PMA
P010019: FOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES
FDA PMA · Lenses, soft contact, extended wear · Alcon Laboratories, Inc.
Key facts
| PMA number | P010019 |
|---|---|
| Trade name | FOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES |
| Generic name | Lenses, soft contact, extended wear |
| Applicant | Alcon Laboratories, Inc. |
| Owner/operator | Alcon Laboratories, Inc. |
| Product code | LPM |
| Approval date | Oct 11, 2001 |
| Docket number | 01M-0479 |
| Notice date | Oct 19, 2001 |
| Establishment registration | 1610287 |
| FEI number | 1610287 |
At a glance
- 10–99 Supplements
- May 29, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 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: