Drug recall
Cornea
FDA recall event 71561 · Class II · International Sight Restoration, Inc.
Key facts
| Event ID | 71561 |
|---|---|
| Recall numbers | B-0747-15 |
| Recalling firm | International Sight Restoration, Inc. |
| Product type | Biologics |
| Products | Cornea |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant… |
| Initiation date | Jun 10, 2015 |
| Report date | Jul 15, 2015 |
| Termination date | Jul 6, 2015 |
| City | Tampa |
| State | FL |
| Country | United States |
| FEI number | 3007678537 |
At a glance
- 1–9 Products in this recall
- 1–9 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: