Events

Recall of Device Recall Alcon Trocar Cannula Replacement Plug

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
    37147
  • Event Risk Class
    Class 3
  • Event Number
    Z-0610-2007
  • Event Initiated Date
    2007-01-18
  • Event Date Posted
    2007-03-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-09-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49981
  • 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
    Trocar Cannula Replacement Plug - Product Code NGY
  • Reason
    Product is misbranded; 19 gauge schlera plugs distributed in containers labeled as 19 gauge trochar canula plugs.
  • Action
    Recalled by letter on January 22, 2007.

Device

Device Recall Alcon Trocar Cannula Replacement Plug
  • Model / Serial
    Lot F58507
  • Product Classification
    Ophthalmic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide- Hospitals in MD and MN.
  • Product Description
    19 Gauge Trocar Cannula Replacement Plug, Catalog Number 617.32; Manufactured by Alcon Grieshaber, Ltd., Schaffhauxen, Switzerland CH8203.
  • Manufacturer
    Alcon Research, Ltd

Manufacturer

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