Events

Recall of Device Recall Bausch & Lomb Millennium Microsurgical System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Bausch & Lomb 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
    54268
  • Event Risk Class
    Class 2
  • Event Number
    Z-1663-2010
  • Event Initiated Date
    2010-01-15
  • Event Date Posted
    2010-05-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-05-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88015
  • 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 cord - Product Code NFJ
  • Reason
    The ac power cords used on these products are subject to an fda alert -- safety investigation of certain medical device power cords: initial communication, date issued: october 19, 2009.
  • Action
    A "URGENT: POWER CORD RECALL" letter and copies of the FDA Alert dated Oct. 19, 2009 were sent to all customers on or about Jan. 15, 2010, by Stericycle, a recall notification service. The letter describes the product, problem and actions to be taken by the customers as well as FDA's recommendations and actions. The customers were made aware of the FDA Alert concerning the AC power cords and notified that these power cords were used in the devices. They were requested to inspect the power cords for damage and notify the recalling firm if damage is noted or if they have experienced sparking, charring, or firing from the power cords and/or cracking or failure of the prongs. In the absence of those conditions, customers were given the option of returning the power cord for replacement and/or during the regularly scheduled servicing of the device. If you would like a new power cord, please contact Customer Service at 1-800-338-2020 for a free replacement.

Device

Device Recall Bausch & Lomb Millennium Microsurgical System
  • Model / Serial
    All devices manufactured since 2004
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: United States & Puerto Rico; Venezuela, India, Trinidad and Tobago, Colombia, Sri Lanka, Hong Kong, Vietnam, and Peru.
  • Product Description
    Bausch & Lomb Millennium Microsurgical System.
  • Manufacturer
    Bausch & Lomb Inc

Manufacturer

Bausch & Lomb Inc
  • Manufacturer Address
    Bausch & Lomb Inc, 1400 North Goodman Street, Rochester NY 14609-3547
  • Source
    USFDA