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Terminated

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

FDA Recall Z-0978-2017 · Posted 2017-01-09

Recalling FirmAlcon Research, Ltd.
Recall StatusTerminated
Product CodeMSS
Date Initiated2016-09-05
Date Terminated2017-02-10
Product Quantity1,130 units

Reason for Recall

The intraocular lens could become lodged within the cartridge

Firm 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.

Root Cause

Device Design

Distribution Pattern

Distributed to Mexico only

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K112977MONARCH III IOL DELIVERY SYSTEM, MONARCH III C CARTRIDGE, MONARCH III HANDPIECE (H4)Alcon Research, Ltd. · 2012-03-27

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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