Events

Recall of Device Recall Becton Dickinson Microkeratome Blade

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by BD Opthalmic Systems.

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
    25652
  • Event Risk Class
    Class 2
  • Event Number
    Z-0634-03
  • Event Initiated Date
    2003-01-24
  • Event Date Posted
    2003-03-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-04-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26214
  • 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
    Keratome, Battery-Powered - Product Code HMY
  • Reason
    Microkeratome blade may cause irregular corneal flap which may delay patients procedure.
  • Action
    BD Ophthalmic notified customers by telephone and email on 1/ 24/03. Users are requested to destroy blades and Certify destruction by returning reply form.

Device

Device Recall Becton Dickinson Microkeratome Blade
  • Model / Serial
    Manufacturing Lot Numbers: 959, 962, 964, 965, and 966
  • Product Classification
    Ophthalmic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    BD K-3000 Microkeratome Blade || REF 378607
  • Manufacturer
    BD Opthalmic Systems

Manufacturer

BD Opthalmic Systems
  • Manufacturer Address
    BD Opthalmic Systems, 411 Waverly Oaks Road, Waltham MA 02452
  • Source
    USFDA