PMA
P100016: EC-3 INTRAOCULAR LENS (IOL) AND EC-3 PRECISION ASPHERIC LENS (PAL) IOL
FDA PMA · Intraocular lens · Carl Zeiss Meditec Production, LLC
Key facts
| PMA number | P100016 |
|---|---|
| Trade name | EC-3 INTRAOCULAR LENS (IOL) AND EC-3 PRECISION ASPHERIC LENS (PAL) IOL |
| Generic name | Intraocular lens |
| Applicant | Carl Zeiss Meditec Production, LLC |
| Owner/operator | Carl Zeiss Meditec AG (Jena) |
| Product code | HQL |
| Approval date | Oct 19, 2010 |
| Docket number | 10M-0556 |
| Notice date | Nov 17, 2010 |
| Establishment registration | 3010126268 |
| FEI number | 3010126268 |
At a glance
- 10–99 Supplements
- Aug 17, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 100–999 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: