Device recall
Z-0443-2022: iDesign, Model - G300: System AWS (International), System AWS (China), Advanced…
FDA device recall · Class II · AMO Manufacturing USA, LLC
Key facts
| Recall number (Z-number) | Z-0443-2022 |
|---|---|
| Recall event | 88986 |
| Product | iDesign, Model - G300: System AWS (International), System AWS (China), Advanced WaveScan Studio (United States); iDesign Refractive Studio Aberrometer (International) and (United States), Model: G301 |
| Product code | LZS |
| Recalling firm | AMO Manufacturing USA, LLC |
| Recall class | Class II |
| Status | Open, Classified |
| PMA numbers | P930016 |
| FEI number | 3006695864 |
At a glance
- None 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