Drug recall
Cornea
FDA recall event 95206 · Class II · Indiana Lions Eye Bank, Inc. (dbA VisionFirst Indiana Lions Eye Bank)
Key facts
| Event ID | 95206 |
|---|---|
| Recall numbers | B-0040-2025 |
| Recalling firm | Indiana Lions Eye Bank, Inc. (dbA VisionFirst Indiana Lions Eye Bank) |
| Product type | Biologics |
| Products | Cornea |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Human corneas, recovered from a donor in which donor suitability was not adequately determined, were distributed. |
| Initiation date | Jul 18, 2024 |
| Report date | Nov 13, 2024 |
| Termination date | Nov 4, 2024 |
| City | Carmel |
| State | IN |
| Country | United States |
| FEI number | 3000718320 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: