Events

Recall of Device Recall CUSTOMPAK

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
    68335
  • Event Risk Class
    Class 2
  • Event Number
    Z-1947-2014
  • Event Initiated Date
    2014-05-16
  • Event Date Posted
    2014-06-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-12-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127370
  • 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
    General surgery tray (kit) - Product Code LRO
  • Reason
    Alcon custom-pak which is supposed to contain a 27g anterior chamber cannula (27g x 7/8 in) actually contains a 27g sharp tip needle.
  • Action
    Alcon sent an Urgert Market Withdrawal letter dated May 14, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review their inventory to determine if they have any affected product, place the affected product into quarantine to ensure it is not used, return the attached Response Form via fax to 817-302-4337 or email market.action@Alcon.com. Customers with questions were instructed to call 1-800-862-5266.

Device

Device Recall CUSTOMPAK
  • Model / Serial
    Alcon Assembly Numbers 9795-37, 11233-14, and 13334-04 bearing Lot numbers 1584114H, 1577346H, 1595079H, 1589608H, 1595079H, 1585992H, 1580988H, 1585992H, and 1580492H.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including North Carolina and Maine
  • Product Description
    Alcon CUSTOM-PAK containing Anterior Chamber Cannula 27G Component Part Number 585006 contained in Alcon Assembly Numbers 9795-37, 11233-14, and 13334-04. || The product is typically inserted through an incision during cataract surgery to deliver balanced salt solution to help anterior chamber space and replace fluids that are lost during surgery.
  • 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