Events

Recall of BD Visitec EdgeAhead MVR Knife

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Becton Dickinson and Company.

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
    55254
  • Event Risk Class
    Class 3
  • Event Number
    Z-1597-2010
  • Event Initiated Date
    2010-04-06
  • Event Date Posted
    2010-05-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90421
  • 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
    Knife, ophthalmic - Product Code HNN
  • Reason
    A field action was initiated due to a recent customer complaint from japan there is a labeling mixup and that some of the bd visitec edgeahead mvr knife 0.90mm (20g), ref 585230, shelf packs may contain bd visitec edgeahead slit knife 2.3mm (40 degree), ref 8009918.
  • Action
    BD Medical issued a "Voluntary Advisory Notice" dated April 6, 2010. Consignees were informed of the affected product and asked to complete the enclosed Customer Response Form indicating whether the product will be returned to the firm. For further information, contact BD Medical Opthalmic Systems at 1-781-906-7952 or via email at ahusebo@bd.com.

Device

BD Visitec EdgeAhead MVR Knife
  • Model / Serial
    Model # 585230, Lot 9202221
  • Product Classification
    Ophthalmic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- United States, Canada and Japan.
  • Product Description
    BD Visitec EdgeAhead MVR Knife, BD Opthalmic Systems, Waltham, MA. || Intended for use in cataract surgery to create self-sealing stab incisions through the cornea or sclera. Also used in retinal surgery for sclerotomy incisions.
  • Manufacturer
    Becton Dickinson and Company

Manufacturer

Becton Dickinson and Company
  • Manufacturer Address
    Becton Dickinson and Company, 411 Waverley Oaks Rd Ste 2229, Waltham MA 02452-8448
  • Source
    USFDA