PMA
P990014: HYDROVIEW COMPOSITE HYDROGEL FOLDABLE UV-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS
FDA PMA · Intraocular lens · Bausch & Lomb, Inc.
Key facts
| PMA number | P990014 |
|---|---|
| Trade name | HYDROVIEW COMPOSITE HYDROGEL FOLDABLE UV-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS |
| Generic name | Intraocular lens |
| Applicant | Bausch & Lomb, Inc. |
| Owner/operator | Bausch & Lomb Incorporated |
| Product code | HQL |
| Approval date | Nov 12, 1999 |
| Docket number | 99M-5135 |
| Notice date | Dec 10, 1999 |
| Establishment registration | 1281950 |
| FEI number | 1281950 |
At a glance
- 1–9 Supplements
- May 2, 2008 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- No Withdrawn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: