PMA
P080021: XACT FOLDABLE HYDROPHOBIC ACRYLIC ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)
FDA PMA · Intraocular lens · Bausch & Lomb, Incorporated
Key facts
| PMA number | P080021 |
|---|---|
| Trade name | XACT FOLDABLE HYDROPHOBIC ACRYLIC ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL) |
| Generic name | Intraocular lens |
| Applicant | Bausch & Lomb, Incorporated |
| Owner/operator | Bausch & Lomb Incorporated |
| Product code | HQL |
| Approval date | Feb 2, 2009 |
| Docket number | 09M-0049 |
| Notice date | Feb 6, 2009 |
| Establishment registration | 1281950 |
| FEI number | 1281950 |
At a glance
- None Supplements
- Feb 2, 2009 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- None 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: