Class 2 Device Recall LAUREATE World Phaco System

• Date Initiated by Firm: July 28, 2016
• Date Posted: September 15, 2016
• Recall Status: Terminated 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/ Manufacturer: Alcon Research, Ltd.; 6201 South Fwy; Fort Worth TX 76134-2099
• For Additional Information Contact: Customer Service; 800-862-5266
• Manufacturer Reason for Recall: Steps 16-25 are missing from the LAUREATE Multipak FMS Directions for Use (DFU)
• FDA Determined Cause: 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.