Events

Recall of Constellation Vision System Pneumatic Handpiece

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Alcon Grieshaber AG.

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
    65006
  • Event Risk Class
    Class 2
  • Event Number
    Z-1506-2013
  • Event Initiated Date
    2013-04-17
  • Event Date Posted
    2013-06-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-01-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117654
  • 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
    Instrument, vitreous aspiration and cutting, ac-powered - Product Code HQE
  • Reason
    Alcon is conducting a medical device removal for the constellation pneumatic handpiece, dsp, product number 725.01. this action is being taken because the forceps or scissors tips (sold separately) may dislodge from the hand piece, if not attached by the user according to the directions for use.
  • Action
    Alcon sent an "URGENT: MEDICAL DEVICE REMOVAL" letter on April 17, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact your local Alcon Sales Representative for questions regarding this notice.

Device

Constellation Vision System Pneumatic Handpiece
  • Model / Serial
    All Lots of the Constellation Vision System Pneumatic Handpiece, DSP, product number 725.01
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: US (nationwide) and countries of: Argentina, Australia, Austria, Belgium, Canada, Chile, China, Egypt, France, Germany, Great Britain, India, Ireland, Israel, Italy, Japan, Kazakhstan, Kuwait, Kyrgyzstan, Lebanon, Korea, Malaysia, Mexico, Pakistan, Peru, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Turkistan, Venezuela, and Veit Nam.
  • Product Description
    The Constellation Vision System Pneumatic Handpiece. || Indicated for both anterior and posterior segment opthalmic surgery.
  • Manufacturer
    Alcon Grieshaber AG

Manufacturer

Alcon Grieshaber AG
  • Manufacturer Address
    Alcon Grieshaber AG, Winkelriedstrasse 52, Schaffhausen Switzerland
  • Manufacturer Parent Company (2017)
    Novartis Ag
  • Source
    USFDA