Recall Z-2081-2016
Alcon Research, Ltd. · initiated May 24, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
CENTURION Vision System
Codes / lots: Serial Number 1601444801X
Reason for recall
The grounding pin within the Power Entry Switch on certain systems was susceptible to detachment when the AC power cable is removed.
FDA-determined cause: Nonconforming Material/Component
Action taken
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.
Details
- Recall number
- Z-2081-2016
- Initiated
- May 24, 2016
- Posted by FDA
- June 28, 2016
- Terminated
- April 13, 2017
- Product code
- HQC – Unit, Phacofragmentation
- Quantity
- 1 unit
- Distribution
- US Distribution to Illinois
- Recalling firm
- Alcon Research, Ltd., Fort Worth, TX