Events

Recall of Constellation Vision System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Alcon Research LTD dba Alcon Laboratories, Inc..

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
    55648
  • Event Risk Class
    Class 1
  • Event Number
    Z-1924-2010
  • Event Initiated Date
    2010-04-30
  • Event Date Posted
    2010-07-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-09-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91443
  • 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
    unit, phacofragmentation - Product Code HQC
  • Reason
    Alcon identified system performance and machine settings that may impact the infusion performance of the constellation vision system, causing unexpected shut down, unresponsive touch screens, and fluidics issues.
  • Action
    The firm, Alcon, sent a "URGENT: MEDICAL DEVICE RECALL" letter dated July 2, 2010, along with training material to all customers. The letter informed the customers of the problem and indicated that Alcon Surgical Sales representative will be contacting them in the near future to follow-up on this training material and to answer any questions you may have. Alcon informed the customers that this action will not require removal of the CONSTELLATION Vision System from their facility. The letter also informed the customers that their Alcon Technical Customer Service Representative will be contacting them when we are authorized to provide you with the software and hardware updates for your system. For assistance and questions regarding the CONSTELLATION Vision System, customers were told they may contact their Alcon Surgical Sales Representative or Alcon Technical Consumer Affairs at 1-800-561-6466, Option 8.

Device

Constellation Vision System
  • Model / Serial
    All lot/serial numbers
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution.
  • Product Description
    Constellation Vision System, Model: Constellation T, Catalogue Number: 8065751558 || The Constellation Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery in addition to the indications included with the optional Next Generation laser.
  • Manufacturer
    Alcon Research LTD dba Alcon Laboratories, Inc.

Manufacturer

Alcon Research LTD dba Alcon Laboratories, Inc.
  • Manufacturer Address
    Alcon Research LTD dba Alcon Laboratories, Inc., 15800 Alton Pkwy, Irvine CA 92618-3818
  • Manufacturer Parent Company (2017)
    Novartis Ag
  • Source
    USFDA