Devices

Device Recall MONARCH II

Model / Serial
Lot 174249 Exp 07/2010 Lot 174250 Exp 07/2010 and Lot 174244 Exp 07/2010
Product Classification
Ophthalmic Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide and OUS: Brazil, Canada, Chile, Hong Kong, Singapore and India.
Product Description
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.
Manufacturer
Alcon Laboratories, Inc
1 Event
- Recall of Device Recall MONARCH II

Manufacturer

Alcon Laboratories, Inc

Manufacturer Address
Alcon Laboratories, Inc, 6201 South Fwy, Fort Worth TX 76134-2001
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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