Recall Z-2081-2016 ยท HQC Unit, Phacofragmentation
Alcon Research, Ltd.
CENTURION Vision System
| Date | Jun 28, 2016 (initiated May 24, 2016) |
| Status | Terminated |
| Reason | The grounding pin within the Power Entry Switch on certain systems was susceptible to detachment when the AC power cable is removed. |
| Root cause | Nonconforming Material/Component |
| Action | Alcon has already notified the affected customer verbally on May 24, 2016, and via written correspondence on June 1, 2016. The device was corrected on May 26, 2016, and the Power Entry Switch that was removed from the customers CENTURION Vision System did not exhibit a grounding pin susceptible to detachment. For further questions, please call (817) 293-0450. |
| Quantity | 1 unit |
| Distribution | US Distribution to Illinois |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121555 | CENTURION VISION SYSTEM Alcon Laboratories, Inc., Dec 21, 2012 |