FDA Medical Device Recalls (openFDA)
Alcon Research, Ltd.: Alcon Monarch III (1) "C" Cartridge The device is used for implanting AcrySof intraocular lenses in the eye following cataract removal
- Recall number
- Z-0978-2017
- Recalling firm
- Alcon Research, Ltd.
- Product
- Alcon Monarch III (1) "C" Cartridge The device is used for implanting AcrySof intraocular lenses in the eye following cataract removal
- Status
- Terminated
- Initiated
- 2016-09-05
- Posted
- 2017-01-09
- Terminated
- 2017-02-10
- Reason
- The intraocular lens could become lodged within the cartridge
- 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
- 1,130 units
- Distribution
- Distributed to Mexico only
- Lot, serial or model codes
- Alcon Monarch II C Cartridge Model 8065977762, Lot Number 32395407, Manufacture Date 8/13/2015
- 510(k) numbers
- ["K112977"]
- PMA numbers
- not on file
- Product code
- MSS
- Firm FEI
- 1610287
- Firm city
- Fort Worth
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28