Events

Recall of MOLTENO IMPLANT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by IOP 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
    145220
  • Event Risk Class
    II
  • Event Initiated Date
    1998-07-13
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    Implant has a curve in the translimbal tube and is not up to specifications and may be more difficult for the surgeon to obtain precise placement into the anterior chamber.

Device

MOLTENO IMPLANT
  • Model / Serial
    Model Catalog: L2 (Lot serial: L21003 UNIT NO. 182)
  • Product Description
    MOLTENO IMPLANT
  • Manufacturer
    IOP INC.

Manufacturer

IOP INC.
  • Manufacturer Address
    COSTA MESA
  • Source
    HC