Drug recall
Treatment packs used on the VisuMax Laser Keratome. Size M Manufactured by Carl Zeiss Meditec AG, Jena…
FDA recall event 67440 · Class II · Carl Zeiss Meditec AG
Key facts
| Event ID | 67440 |
|---|---|
| Recall numbers | Z-1153-2014 |
| Recalling firm | Carl Zeiss Meditec AG |
| Product type | Devices |
| Products | Treatment packs used on the VisuMax Laser Keratome. Size M Manufactured by Carl Zeiss Meditec AG, Jena, Germany. The VisuMax Laser Keratome is indicated for the following: In the creation of a corneal… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Carl Zeiss Treatment pack, lot number M 130010, size M, may actually contain size S. |
| Initiation date | Feb 3, 2014 |
| Report date | Mar 19, 2014 |
| Termination date | Mar 7, 2014 |
| City | Jena |
| Country | Germany |
| FEI number | 3001362763 |
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: