Events

Recall of Device Recall Bipolar Forceps

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
    69743
  • Event Risk Class
    Class 2
  • Event Number
    Z-0527-2015
  • Event Initiated Date
    2014-11-11
  • Event Date Posted
    2014-12-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-02-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131453
  • 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
    Electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • Reason
    The product is sold and labeled as eo sterilized, however the units were not sterilized prior to shipment to customers.
  • Action
    On November 11, 2014, the firm sent letters to their customers notifiying them of the medical device recall. The recalling firm asked their customers to stop using the recalled product, remove it from inventory, return the affected product, and complete a response form.

Device

Device Recall Bipolar Forceps
  • Model / Serial
    Lot numbers 061814-95 and 080614-91
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: US (nationwide) and countries of: Indonesia, South Africa, Switzerland, Brazil, Kazakhstan, and Pakistan.
  • Product Description
    Alcon Single-Use Curved Jewelers/Iris Bipolar Forceps REF 8065129101 Sterile RX only; Alcon Single-Use Straight/Iris Bipolar Forceps REF 8065129501 Sterile RX only. Usage: Electrosurgical instrument for ophthalmic 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