PMA
P820035: OPTIFLEX ANTERIOR CHAMBER LENSES (L1-L5)
FDA PMA · Intraocular lens · Alcon
Key facts
| PMA number | P820035 |
|---|---|
| Trade name | OPTIFLEX ANTERIOR CHAMBER LENSES (L1-L5) |
| Generic name | Intraocular lens |
| Applicant | Alcon |
| Owner/operator | Alcon Laboratories, Inc. |
| Product code | HQL |
| Approval date | Feb 28, 1986 |
| Docket number | 86M-0231 |
| Notice date | Jun 18, 1986 |
| Establishment registration | 1610287 |
| FEI number | 1610287 |
At a glance
- 1–9 Supplements
- Sep 4, 1998 Latest supplement decision
- Yes Withdrawn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: