Events

Recall of Device Recall eyepak Tray Support Cover

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
    68487
  • Event Risk Class
    Class 2
  • Event Number
    Z-2694-2014
  • Event Initiated Date
    2014-06-03
  • Event Date Posted
    2014-09-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-07-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128029
  • 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
    Drape, patient, ophthalmic - Product Code HMT
  • Reason
    The peel pouches of the tray support covers may be insufficiently sealed so that sterility cannot be assured.
  • Action
    Alcon Research sent an Urgent Medical Device Recall letter dated June 3, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please follow these important steps: 1) Review your inventory of Tray Support Covers to determine if you have any units from the affected Lots in stock. 2) Place the product aside to ensure it is not used. 3) Return the attached Response Form via fax or email to Alcon. Please return the Response Form even if you do not have any inventory from the affected lots. 4) Alcon will contact you to arrange the return of your inventory. If you have any further questions, concerns, or need assistance with obtaining replacement product, please contact Alcon Customer Service at 1-800-862-5266.

Device

Device Recall eyepak Tray Support Cover
  • Model / Serial
    Item Number 8065740745 with Lot numbers 613207-07V, 613221-07V, 613228-07V, 613249-07V, 613256-07V, 35206V, and 352699V.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - Nationwide Distribution and the countries of Australia, Belgium, and Canada.
  • Product Description
    eye-pak 7407 Tray Support Cover REF 8065740745
  • 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