Device recall
Z-3282-2018: C-flex 570C +19.0D Intraocular Lens Product Usage: C-flex IOLs are designed to…
FDA device recall · Class II · Rayner Intraocular Lenses Limited
Key facts
| Recall number (Z-number) | Z-3282-2018 |
|---|---|
| Recall event | 80943 |
| Product | C-flex 570C +19.0D Intraocular Lens Product Usage: C-flex IOLs are designed to be surgically implanted into the capsular bag of the human eye as a replacement for the crystalline lens following phacoemulsification |
| Product code | HQL |
| Recalling firm | Rayner Intraocular Lenses Limited |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 24, 2020 |
| PMA numbers | P060011 |
| FEI number | 3012304651 |
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