PMA
P840039: ULTRA VIOLET (UV) AND NON-UV ABSORBING PMMA INTRAOCULAR LENSES
FDA PMA · Intraocular lens · Bausch & Lomb, Inc.
Key facts
| PMA number | P840039 |
|---|---|
| Trade name | ULTRA VIOLET (UV) AND NON-UV ABSORBING PMMA INTRAOCULAR LENSES |
| Generic name | Intraocular lens |
| Applicant | Bausch & Lomb, Inc. |
| Owner/operator | Bausch & Lomb Incorporated |
| Product code | HQL |
| Approval date | Mar 28, 1986 |
| Docket number | 86M-0169 |
| Notice date | Jul 1, 1986 |
| Establishment registration | 1032500 |
| FEI number | 1032500 |
At a glance
- 10–99 Supplements
- Aug 9, 2022 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- 10–99 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: