PMA
P090022: LENSTEC SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS
FDA PMA · Intraocular lens · Lenstec, Inc.
Key facts
| PMA number | P090022 |
|---|---|
| Trade name | LENSTEC SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS |
| Generic name | Intraocular lens |
| Applicant | Lenstec, Inc. |
| Owner/operator | LENSTEC, INC. |
| Product code | HQL |
| Approval date | Apr 12, 2010 |
| Docket number | 10M-0220 |
| Notice date | Apr 23, 2010 |
| Establishment registration | 1063199 |
| FEI number | 3001659659 |
At a glance
- 10–99 Supplements
- Apr 15, 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- No Withdrawn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: