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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 IIsee related information
Date Initiated by FirmJuly 07, 2008
Date PostedSeptember 23, 2008
Recall Status1 Terminated 3 on August 26, 2009
Recall NumberZ-2441-2008
Recall Event ID 49113
510(K)NumberK001157 
Product Classification Cartridge - Product Code KYB
ProductMONARCH 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 ContactChris 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
ActionThe 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 Commerce7962 units
DistributionNationwide and OUS: Brazil, Canada, Chile, Hong Kong, Singapore and India.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = KYB
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