PMA
P030002: CRYSTALENS MODEL AT-45 ACCOMMODATING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)
FDA PMA · Lens, intraocular, accommodative · Bausch & Lomb, Inc.
Key facts
| PMA number | P030002 |
|---|---|
| Trade name | CRYSTALENS MODEL AT-45 ACCOMMODATING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL) |
| Generic name | Lens, intraocular, accommodative |
| Applicant | Bausch & Lomb, Inc. |
| Owner/operator | Bausch & Lomb Incorporated |
| Product code | NAA |
| Approval date | Nov 14, 2003 |
| Docket number | 04M-0012 |
| Notice date | Jan 12, 2004 |
| Establishment registration | 1281950 |
| FEI number | 1281950 |
At a glance
- 10–99 Supplements
- Apr 8, 2022 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- No Withdrawn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: