Z-0978-2017Class II

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

Name: Z-0978-2017 Alcon Monarch III (1) "C" Cartridge The device is used for implanting AcrySof intraocular lenses in the eye...
Creator: Alcon Research, Ltd.
Published: 2016-09-05
License: https://open.fda.gov/license/

Alcon Laboratories / initiated 2016-09-05 / Terminated / root cause: design

FDA source

Alcon Research, Ltd. began a recall of Alcon Monarch III (1) "C" Cartridge The device is used for implanting AcrySof intraocular lenses in the eye following cataract removal on 2016-09-05. FDA classified it as Class II and gives the reason as "The intraocular lens could become lodged within the cartridge". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0978-2017
Classification: Class II
Status: Terminated
Initiated: 2016-09-05
Posted: 2017-01-09
Terminated: 2017-02-10
Recalling firm: Alcon Laboratories
Product: Alcon Monarch III (1) "C" Cartridge The device is used for implanting AcrySof intraocular lenses in the eye following cataract removal
Product code: MSS Folders And Injectors, Intraocular Lens (Iol)
Reason for recall: The intraocular lens could become lodged within the cartridge
Root cause tag: design
FDA root cause: Device Design
Action: Alcon sent an Urgent Field Safety Action letter dated August 2016 to all affected consignees who received the affected product. Customers were instructed to check their inventory and segregate any of the affected cartridges. Customers were also asked to complete and return the Product Recall Response Form. , requesting the return of any units in their inventory. If customers had transferred product to other organizations, they were asked to provide them with a copy of the notice. Customers with questions were instructed to contact Alcon. For questions regarding this recall call 817-551-3058.
Quantity in commerce: 1,130 units
Distribution: Distributed to Mexico only
Product codes and lots: Alcon Monarch II C Cartridge Model 8065977762, Lot Number 32395407, Manufacture Date 8/13/2015

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0978-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0978-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-18	2017-01-09

Product code MSS

K112977Class IMonarch III IOL Delivery System, Monarch III C Cartridge, Monarch III Handpiece (H4)Alcon Research, Ltd. / cleared 2012-03-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)