PMA
P910061: MODEL LI30U SOFLEX(TM) UV-ABSORB. INTRAOCULAR LENS
FDA PMA · Intraocular lens · Bausch & Lomb
Key facts
| PMA number | P910061 |
|---|---|
| Trade name | MODEL LI30U SOFLEX(TM) UV-ABSORB. INTRAOCULAR LENS |
| Generic name | Intraocular lens |
| Applicant | Bausch & Lomb |
| Owner/operator | Bausch & Lomb Incorporated |
| Product code | HQL |
| Approval date | Sep 2, 1994 |
| Docket number | 94M-0339 |
| Notice date | Oct 14, 1994 |
| Establishment registration | 1281950 |
| FEI number | 1281950 |
At a glance
- 10–99 Supplements
- Jan 19, 2022 Latest supplement decision
- No Withdrawn
- No 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: