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U.S. Department of Health and Human Services

Class 2 Device Recall MONARCH II

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  Class 2 Device Recall MONARCH II see related information
Date Initiated by Firm July 07, 2008
Date Posted September 23, 2008
Recall Status1 Terminated 3 on August 26, 2009
Recall Number Z-2441-2008
Recall Event ID 49113
510(K)Number k001157  
Product Classification Cartridge - Product Code KYB
Product MONARCH¿ II IOL Delivery System, Cartridge Model B, part #8065977758, packaged in pouches, 10 pouches/carton, and labeled in part ***Alcon Laboratories Fort Worth, Texas 76134 USA***for AcrySof¿ IOLs*** The product is used for implanting intraocular lenses (IOLs) into the eye following cataract removal. Each cartridge is imprinted with the model type on the wing of the Monarch II cartridge which can be visually verified prior to use.
Code Information Lot 174249 Exp 07/2010 Lot 174250 Exp 07/2010 and  Lot 174244 Exp 07/2010
Recalling Firm/
Manufacturer		 Alcon Laboratories, Inc
6201 South Fwy
Fort Worth TX 76134-2001
For Additional Information Contact Chris Danford
800-862-5266
Manufacturer Reason
for Recall		 Delivery cartridge for implanting intraocular lenses is mislabeled and may result in complicated insertion and damage to the lens.
FDA Determined
Cause 2		 Mixed-up of materials/components
Action The recalling firm notified healthcare professional consignees and affiliated foreign distributors by letter on 07/07/08 and advised of the mislabeled device and potential hazard associated with delivery of the IOL. Consignees were instructed to return identified lots in their inventory and to return the enclosed business reply card for product replacement. Contact Stericycle Inc at 1-800-668-4391 for assistance with returning the recalled product. Contact Alcon Customer Service at 1-800-862-5266 for questions about the recall.
Quantity in Commerce 7962 units
Distribution Nationwide and OUS: Brazil, Canada, Chile, Hong Kong, Singapore and India.
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 = KYB and Original Applicant = ALCON RESEARCH, LTD.
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