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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 October 06, 2014
Date Posted May 03, 2016
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = ALCON LABORATORIES, INC.
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