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U.S. Department of Health and Human Services

Class 2 Device Recall phacofragmentation system

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  Class 2 Device Recall phacofragmentation system see related information
Date Initiated by Firm May 24, 2016
Date Posted June 28, 2016
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = ALCON LABORATORIES, INC.
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