Events

Recall of Device Recall Alcon/Grieshaber Morris ILM Forceps, Direct Action

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
    47401
  • Event Risk Class
    Class 3
  • Event Number
    Z-1461-2008
  • Event Initiated Date
    2008-03-07
  • Event Date Posted
    2008-05-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-07-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69400
  • 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
    Manual ophthalmic surgical instrument - Product Code HNR
  • Reason
    Device corrosion: forceps are prone to corrosion and possibly premature fracture and/or malfunction.
  • Action
    Consignees were notified by an Urgent Medical Device Recall that was sent via fax on 03/07/08. Users were instructed to cease using the affected products and to return a Recall Acknowledgement Form to the recalling firm. The sales representative will pick up the affected product and discuss replacement alternatives. For additional information, contact 1-800-757-9780.

Device

Device Recall Alcon/Grieshaber Morris ILM Forceps, Direct Action
  • Model / Serial
    Lot Numbers: F58834, F60464, F60465 and F60466.
  • Product Classification
    Ophthalmic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including states of AL and CA.
  • Product Description
    Alcon/Grieshaber Morris ILM Forceps, Direct Action; Manual ophthalmic surgical instrument, Catalog Number: 641.22; Non-sterile/Reusable; Alcon Laboratories, Inc., Fort Worth, TX 76134.
  • Manufacturer
    Alcon Research, Ltd

Manufacturer

Alcon Research, Ltd
  • Manufacturer Address
    Alcon Research, Ltd, 6201 South Fwy, Fort Worth TX 76134-2001
  • Source
    USFDA