PMA
P210005: IC-8 Apthera Intraocular Lens (IOL)
FDA PMA · Extended depth of focus intraocular lens · Acu Focus, Inc.
Key facts
| PMA number | P210005 |
|---|---|
| Trade name | IC-8 Apthera Intraocular Lens (IOL) |
| Generic name | Extended depth of focus intraocular lens |
| Applicant | Acu Focus, Inc. |
| Owner/operator | Bausch & Lomb Incorporated |
| Product code | POE |
| Approval date | Jul 22, 2022 |
| Docket number | 22M-1672 |
| Notice date | Jul 27, 2022 |
| Establishment registration | 1119279 |
| FEI number | 1119279 |
At a glance
- 10–99 Supplements
- Jul 14, 2026 Latest supplement decision
- No Withdrawn
- Yes 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: