Device recall
Z-1500-2017: EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra…
FDA device recall · Class II · Haag-Streit USA Inc
Key facts
| Recall number (Z-number) | Z-1500-2017 |
|---|---|
| Recall event | 76405 |
| Product | EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra Ocular Lenses (IOLs). |
| Product code | NFJ |
| Recalling firm | Haag-Streit USA Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 22, 2019 |
| 510(k) numbers | K142423 |
| FEI number | 1000136533 |
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