Events

Recall of IOL MASTER 700

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CARL ZEISS CANADA LTD..

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
    75643
  • Event Risk Class
    III
  • Event Initiated Date
    2016-07-11
  • 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
    The current iol master 700 software version 1.14.84 sometimes shows an unexpected behavior during toric iol power calculation with the haigis suite: in some cases of low cylinder power with a theoretically ideal iol below the delivery range of the selected toric iol model the device suggests a toric iol with significant remaining cylinder refraction.

Device

IOL MASTER 700
  • Model / Serial
    Model Catalog: IOL MASTER 700 (Lot serial: 1128480); Model Catalog: IOL MASTER 700 (Lot serial: 1131493); Model Catalog: IOL MASTER 700 (Lot serial: 1131495); Model Catalog: IOL MASTER 700 (Lot serial: 1131507); Model Catalog: IOL MASTER 700 (Lot serial: 1131532); Model Catalog: IOL MASTER 700 (Lot serial: 1131535); Model Catalog: IOL MASTER 700 (Lot serial: 1128467); Model Catalog: IOL MASTER 700 (Lot serial: 1131539)
  • Product Description
    IOL Master 700
  • Manufacturer
    CARL ZEISS CANADA LTD.

Manufacturer

CARL ZEISS CANADA LTD.