Events

Recall of Laseredge Knife

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
    21208
  • Event Initiated Date
    2017-03-13
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 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
    If excessive force is required to push a dull blade through the cornea this may result in a sub-optimal incision. uncontrolled penetration through the cornea may also result in injury to anterior segment structures.
  • Action
    Product to be returned to supplier

Device

Laseredge Knife
  • Model / Serial
    Model: , Affected: 2.85MM SLIT KNIFE ANG, 6/Box Lots MAYC970, MAYC960, MABX010, MAYL090, 3.0MM SLIT KNIFE ANG BEVUP, 6/Box Lots MAKG600, MAMM950, 1.1MM ARROW KNIFE ANGLED (6/BOX) Lots MAYT510, 1.6MMX1.8MM TRAPEZOLD ANG 6/Box Lots MAXL130, MAWF130, MBRF780
  • Manufacturer
    Bausch & Lomb Inc

Manufacturer

Bausch & Lomb Inc