Events

Recall of Device Recall Bausch & Lomb Millennium 20 Ga. High Speed Posterior Vitrectomy Pack

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
    36980
  • Event Risk Class
    Class 2
  • Event Number
    Z-0496-2007
  • Event Initiated Date
    2006-12-14
  • Event Date Posted
    2007-05-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-04-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49703
  • 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
    Vitrectomy Cutter - Product Code HQE
  • Reason
    The cutter tip could break during a procedure.
  • Action
    Recall letters were issued via e-mail to surgeons on 12/14/06 and via overnight mail on 12/14/06 to surgeons and operating room supervisors requesting immediate segregation and return of the product.

Device

Device Recall Bausch & Lomb Millennium 20 Ga. High Speed Posterior Vitrectomy Pack
  • Model / Serial
    All lots
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution ---- including USA and countries of Canada, China, Japan, Australia, Hong Kong, India, Malaysia, New Zealand, Singapore, Korea, Taiwan, Thailand, Argentina, Brazil, Mexico, and The Netherlands.
  • Product Description
    Bausch & Lomb Millennium 20 Ga. High Speed Posterior Vitrectomy Pack, Catalog #CX4920, containing 1/20-gauge high speed vitrectomy cutter as well as other accessories. Catalog #USSCX4920A is also included in the recall, which is used by customers for ordering only . There is no labeling associated with this catalog number. This catalog number is used for ordering Cat. #4920 along with Cat. #MVS1011C-20g, Light Pipe (which is not under recall). These two products are packaged separately and are not bundled in any way. They are merely shipped at the same time. The firm name on the label is Bausch & Lomb Incorporated, Rochester, NY.
  • Manufacturer
    Bausch & Lomb Inc

Manufacturer

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