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U.S. Department of Health and Human Services

Class 2 Device Recall Alcon MONARCH III C Cartridge

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  Class 2 Device Recall Alcon MONARCH III C Cartridge see related information
Date Initiated by Firm September 05, 2016
Date Posted January 09, 2017
Recall Status1 Terminated 3 on February 10, 2017
Recall Number Z-0978-2017
Recall Event ID 75049
510(K)Number K112977  
Product Classification Folders and injectors, intraocular lens (iol) - Product Code MSS
Product Alcon Monarch III (1) "C" Cartridge
The device is used for implanting AcrySof intraocular lenses in the eye following cataract removal
Code Information Alcon Monarch II C Cartridge Model 8065977762, Lot Number 32395407, Manufacture Date 8/13/2015
Recalling Firm/
Manufacturer		 Alcon Research, Ltd.
6201 South Fwy
Fort Worth TX 76134-2099
For Additional Information Contact Wilma Taylor-Nunn
817-551-3058
Manufacturer Reason
for Recall		 The intraocular lens could become lodged within the cartridge
FDA Determined
Cause 2		 Device Design
Action Alcon sent an Urgent Field Safety Action letter dated August 2016 to all affected consignees who received the affected product. Customers were instructed to check their inventory and segregate any of the affected cartridges. Customers were also asked to complete and return the Product Recall Response Form. , requesting the return of any units in their inventory. If customers had transferred product to other organizations, they were asked to provide them with a copy of the notice. Customers with questions were instructed to contact Alcon. For questions regarding this recall call 817-551-3058.
Quantity in Commerce 1,130 units
Distribution Distributed to Mexico only
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 = MSS and Original Applicant = ALCON RESEARCH, LTD.
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