Device recall
Z-1268-2015: ML 7090 Calibrated LASIK Blade (CLB); CLB CALIBRATED LASIK BLADE 10. ML 7090…
FDA device recall · Class II · Med-logics Inc
Key facts
| Recall number (Z-number) | Z-1268-2015 |
|---|---|
| Recall event | 70348 |
| Product | ML 7090 Calibrated LASIK Blade (CLB); CLB CALIBRATED LASIK BLADE 10. ML 7090 Calibrated LASIK Blade (CLB) is to be used as replacement blades for the AMO Amadeus Microkeratome, to perform lamellar keratectomy procedures. |
| Product code | HNO |
| Recalling firm | Med-logics Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 28, 2015 |
| 510(k) numbers | K033293 |
| FEI number | 1000142667 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database