PMA
P030016: VISIAN ICL (IMPLANTABLE COLLAMER LENS)
FDA PMA · Lens, intraocular, phakic · STAAR Surgical Company
Key facts
| PMA number | P030016 |
|---|---|
| Trade name | VISIAN ICL (IMPLANTABLE COLLAMER LENS) |
| Generic name | Lens, intraocular, phakic |
| Applicant | STAAR Surgical Company |
| Owner/operator | STAAR SURGICAL Company |
| Product code | MTA |
| Approval date | Dec 22, 2005 |
| Docket number | 06M-0340 |
| Notice date | Aug 25, 2006 |
| Establishment registration | 2023826 |
| FEI number | 2023826 |
At a glance
- 10–99 Supplements
- Mar 4, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1,000+ 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: