Device recall
Z-0464-2019: Abbott TECNIS 1-Piece Aspheric Acrylic IOL with the TECNIS iTEC Preloaded…
FDA device recall · Class II · Johnson & Johnson Surgical Vision Inc
Key facts
| Recall number (Z-number) | Z-0464-2019 |
|---|---|
| Recall event | 81408 |
| Product | Abbott TECNIS 1-Piece Aspheric Acrylic IOL with the TECNIS iTEC Preloaded Delivery System, Lens Model PCB00, Sterile, Rx - Product Usage: The lenses are indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction… |
| Product code | HQL |
| Recalling firm | Johnson & Johnson Surgical Vision Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 28, 2021 |
| PMA numbers | P980040, P980040S041 |
| FEI number | 3003843509 |
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