Class 2 Device Recall Phacofragmentation System

• Date Initiated by Firm: October 06, 2014
• Date Posted: May 03, 2016
• Recall Status: Terminated on March 31, 2017
• Recall Number: Z-1597-2016
• Recall Event ID: 73767
• 510(K)Number: K021566
• Product Classification: Unit, phacofragmentation - Product Code HQC
• Product: INFINITI Ultrasound Pack. Catalog Numbers: 8065751716, 8065751717, 8065751718, 8065751720, 8065751721, 8065751723. An ophthalmic microsurgical system indicated for phacoemulsification and removal of cataracts.
• Code Information: Lot numbers: 1623139H, 1623140H, 1623138H, 1623141H, 1623765H, 1623148H, 1623766H, 1623767H, 1623768H, 1623142H
• Recalling Firm/ Manufacturer: Alcon Research, Ltd.; 6201 South Fwy; Fort Worth TX 76134-2099
• For Additional Information Contact: Alcon Customer Service; 800-593-3165
• Manufacturer Reason for Recall: The recalling firm received complaints related to leakage from the tubing near the white luer of the irrigation line for the INFINITI Ultrasound Packs.
• FDA Determined Cause: Process change control
• Action: The recalling firm notified affected customers on 10/6/2014 via a customer letter with an attached Medical Device Removal Response Form. On 10/23/2014, a second notification was sent to 76 customers who did not respond to the initial notification.
• Quantity in Commerce: 6597 packs
• Distribution: Nationwide Distribution.
• 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