Events

Recall of Alcon MONARCH III C Cartridge

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Alcon Research, Ltd..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    75049
  • Event Risk Class
    Class 2
  • Event Number
    Z-0978-2017
  • Event Initiated Date
    2016-09-05
  • Event Date Posted
    2017-01-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-02-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149191
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Folders and injectors, intraocular lens (iol) - Product Code MSS
  • Reason
    The intraocular lens could become lodged within the cartridge.
  • 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.

Device

Alcon MONARCH III C Cartridge
  • Model / Serial
    Alcon Monarch II C Cartridge Model 8065977762, Lot Number 32395407, Manufacture Date 8/13/2015
  • Product Classification
    Ophthalmic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed to Mexico only
  • Product Description
    Alcon Monarch III (1) "C" Cartridge || The device is used for implanting AcrySof intraocular lenses in the eye following cataract removal
  • Manufacturer
    Alcon Research, Ltd.

Manufacturer

Alcon Research, Ltd.
  • Manufacturer Address
    Alcon Research, Ltd., 6201 South Fwy, Fort Worth TX 76134-2099
  • Manufacturer Parent Company (2017)
    Novartis Ag
  • Source
    USFDA