Device recall
Z-1235-2016: KAMRA Inlay, ACI 7000 Corneal Inlay, Part No. 76195-01 and 76195-10 (OUS)…
FDA device recall · Class II · AcuFocus, Inc.
Key facts
| Recall number (Z-number) | Z-1235-2016 |
|---|---|
| Recall event | 73343 |
| Product | KAMRA Inlay, ACI 7000 Corneal Inlay, Part No. 76195-01 and 76195-10 (OUS) Labeling: The KAMRA inlay is indicated for the improvement of near visual acuity in one eye (usually the non-dominant eye) of a presbyopic patient. |
| Product code | LQE |
| Recalling firm | AcuFocus, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 4, 2016 |
| PMA numbers | P120023 |
| FEI number | 3008401069 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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