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.
FDA Recall Z-2441-2008 · Posted 2008-09-23
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Recalling FirmAlcon Laboratories, Inc
Recall StatusTerminated
Product CodeKYB
Date Initiated2008-07-07
Date Terminated2009-08-26
Product Quantity7962 units
Reason for Recall
Delivery cartridge for implanting intraocular lenses is mislabeled and may result in complicated insertion and damage to the lens.
Firm 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.
Root Cause
Mixed-up of materials/components
Distribution Pattern
Nationwide and OUS: Brazil, Canada, Chile, Hong Kong, Singapore and India.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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