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U.S. Department of Health and Human Services

Class 2 Device Recall LAUREATE World Phaco System

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  Class 2 Device Recall LAUREATE World Phaco System see related information
Date Initiated by Firm July 28, 2016
Date Posted September 15, 2016
Recall Status1 Terminated 3 on June 07, 2017
Recall Number Z-2834-2016
Recall Event ID 74825
510(K)Number K021566  
Product Classification Unit, phacofragmentation - Product Code HQC
Product LAUREATE World Phaco System
Code Information Lot Numbers: 1658863H, 1805033H, 1805034H, 1817516H, 1817517H, 1826141H, 1826142H, 1857622H, 1857623H, 1868399H, 1868400H
Recalling Firm/
Alcon Research, Ltd.
6201 South Fwy
Fort Worth TX 76134-2099
For Additional Information Contact Customer Service
Manufacturer Reason
for Recall
Steps 16-25 are missing from the LAUREATE Multipak FMS Directions for Use (DFU)
FDA Determined
Cause 2
Labeling Change Control
Action All remaining inventory of the identified affected products within Alcon DCs will be supplied corrected directions for use material prior to any further shipments.
Quantity in Commerce 8,646 UNITS
Distribution Burundi, China, Iran, South Korea, Taiwan, Thailand, USA. *** The recalled product is not sold in the USA or its territories. However, donated units are in use by a reduced number of USA clients for Medical Missions outside the country.
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.