Drug recall
LAUREATE World Phaco System
FDA recall event 74825 · Class II · Alcon Research, Ltd.
Key facts
| Event ID | 74825 |
|---|---|
| Recall numbers | Z-2834-2016 |
| Recalling firm | Alcon Research, Ltd. |
| Product type | Devices |
| Products | LAUREATE World Phaco System |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Steps 16-25 are missing from the LAUREATE Multipak FMS Directions for Use (DFU) |
| Initiation date | Jul 28, 2016 |
| Report date | Sep 21, 2016 |
| Termination date | Jun 7, 2017 |
| City | Fort Worth |
| State | TX |
| Country | United States |
| FEI number | 1610287 |
At a glance
- 1–9 Products in this recall
- None 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: