Recall of Bausch & Lomb Algerbrush Manual Surgical Instruments; General

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand 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
    20917
  • Event Initiated Date
    2016-12-08
  • Event Country
  • Event Source
    NZMMDSA
  • Event Source URL
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Extra notes in the data
    Recalling Organisation: Bausch & Lomb (NZ) Ltd, c/o Bell Gully, Auckland Vero Centre, 48 Shortland Street, AUCKLAND 1140
  • Reason
    An internal investigation, found that the operating instructions for several of these devices were either missing or obsolete.
  • Action
    Instructions for use to be updated

Device

  • Model / Serial
    Model: , Affected: ALGERBRUSH - II Rust Ring 0.5 mm instrument SKU E0815 A, ALGERBRUSH - II Rust Ring 1.0 mm instrument SKU E0815 B,
  • Manufacturer

Manufacturer