Class 2 Device Recall phacofragmentation system

• Date Initiated by Firm: May 24, 2016
• Date Posted: June 28, 2016
• Recall Status: Terminated on April 13, 2017
• Recall Number: Z-2081-2016
• Recall Event ID: 74282
• 510(K)Number: K121555
• Product Classification: Unit, phacofragmentation - Product Code HQC
• Product: CENTURION Vision System
• Code Information: Serial Number 1601444801X
• Recalling Firm/ Manufacturer: Alcon Research, Ltd.; 6201 South Fwy; Fort Worth TX 76134-2099
• For Additional Information Contact: 817-293-0450
• Manufacturer 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: 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 in Commerce: 1 unit
• Distribution: US Distribution to Illinois
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = HQC