Events

Recall of Topcon 3D Optical Coherence Tomography 3D OCT-1 Maestro systems

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Topcon Corporation.

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
    18685
  • Event Initiated Date
    2015-06-29
  • 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: Device Technologies New Zealand, 47 Arrenway Drive, Albany, AUCKLAND 0632
  • Reason
    In certain usage environments, when the 3d oct-1 is used over a prolonged period of time, dust can penetrate into the optical system and adhere to the surface of the lens. this dust accumulates gradually over time and this can cause a whitish shadow artefact to occur in centre of the image and potentially create a blurry background., if this occurs, the reduced image quality is an obvious anomaly noticed during clinical assessment which cannot be mistaken for patient pathology.
  • Action
    Product to be modified

Device

Topcon 3D Optical Coherence Tomography 3D OCT-1 Maestro systems
  • Model / Serial
    Model: TOP-470109800, Affected: Serial number range: 105104 to 105701
  • Manufacturer
    Topcon Corporation

Manufacturer

Topcon Corporation