Events

Recall of AMO Tecnis CL Foldable Silicone IOL with OptiEdge Design

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Johnson & Johnson Surgical Vision 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
    16755
  • Event Initiated Date
    2014-05-29
  • 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: AMO Australia Pty Limited (NZ), c/- Exel New Zealand Limited, 3 - 5 Westfield Place, Mt Wellington, Auckland
  • Reason
    The manufacturer is taking action as certain silicone tecnis iols may be labeled with the incorrect diopter power.
  • Action
    Product to be returned to supplier

Device

AMO Tecnis CL Foldable Silicone IOL with OptiEdge Design

Manufacturer

Johnson & Johnson Surgical Vision Inc