Events

Recall of Device Recall BD Visitec Disposable Instrument (plastic handle) Capsulorhexis Forceps

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
    49094
  • Event Risk Class
    Class 2
  • Event Number
    Z-2433-2008
  • Event Initiated Date
    2008-07-07
  • Event Date Posted
    2008-09-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72739
  • 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
    Ophthalmic Forceps - Product Code HNR
  • Reason
    Metal particulates present.
  • Action
    BD notified customers by telephone via a script on July 7, 2008 and requested customers to examine their inventory, dispose of product, and replacement product would be provided.

Device

Device Recall BD Visitec Disposable Instrument (plastic handle) Capsulorhexis Forceps
  • Model / Serial
    Lot Number: 8067450 Exp. Date: March 2011
  • Product Classification
    Ophthalmic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution --- including states of CA, IL, KY, MS, PA, and TX.
  • Product Description
    BD Visitec Disposable Instrument (plastic handle) Capsulorhexis Forceps, Sterile || Ref: 581440 || Used during cataract and other ophthalmic surgery procedures to grasp lens capsule.
  • 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