PMA
P030028: ARTISAN (MODEL 206 AND 204) PHAKIC INTRAOCULAR LENS (PIOL) VERISYSE (VRSM5US AND VRSM6US) PHAKIC INTRAOCULAR LENS (PIOL)
FDA PMA · Lens, intraocular, phakic · Ophtec BV
Key facts
| PMA number | P030028 |
|---|---|
| Trade name | ARTISAN (MODEL 206 AND 204) PHAKIC INTRAOCULAR LENS (PIOL) VERISYSE (VRSM5US AND VRSM6US) PHAKIC INTRAOCULAR LENS (PIOL) |
| Generic name | Lens, intraocular, phakic |
| Applicant | Ophtec BV |
| Owner/operator | OPHTEC USA |
| Product code | MTA |
| Approval date | Sep 10, 2004 |
| Docket number | 05M-0026 |
| Notice date | Jan 21, 2005 |
| Establishment registration | 8040449 |
| FEI number | 3002501070 |
At a glance
- 10–99 Supplements
- Apr 24, 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- No Withdrawn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: