Drug recall
Surgical Image Guidance Functionality, software used with NGENUITY 3D Visualization System, Part Number…
FDA recall event 94848 · Class II · Alcon Research LLC
Key facts
| Event ID | 94848 |
|---|---|
| Recall numbers | Z-2412-2024 |
| Recalling firm | Alcon Research LLC |
| Product type | Devices |
| Products | Surgical Image Guidance Functionality, software used with NGENUITY 3D Visualization System, Part Number: 8065000399 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | After surgery initiation, while using surgical image guidance, if significant eye rotation/movement occurs, a software anomaly may cause re-establishment of incorrect new registration angle, range… |
| Initiation date | May 23, 2024 |
| Report date | Jul 24, 2024 |
| 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: