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Recall Observatory FDA recall evidence

Device product

Alcon Monarch III (1) "C" Cartridge The device is used for implanting AcrySof intraocular lenses in the eye following cataract removal

Z-0978-2017

September 05, 2016

Class II

Product summary

Firm
Alcon Research, Ltd.
Event
Event 75049
Status
Terminated
Classification
Class II
Quantity
1,130 units
Official record key
device-enforcement:Z-0978-2017

Official wording

Reason: The intraocular lens could become lodged within the cartridge

Code information: Alcon Monarch II C Cartridge Model 8065977762, Lot Number 32395407, Manufacture Date 8/13/2015

Distribution pattern: Distributed to Mexico only

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The intraocular lens could become lodged within the cartridge