Events

Recall of Topcon Pascal Synthesis and Pascal Synthesis TwinStar (only with EpM software enabled)

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Topcon Medical Laser Systems 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
    20631
  • Event Initiated Date
    2016-10-17
  • 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: Optimed NZ Ltd, Unit 1, 3 Northside Drive, Whenuapai, Auckland 0814
  • Reason
    An anomaly has been discovered with titration, only when the epm software feauture is turrned on during the titration process., this event may occur if the user turns on epm, turns off the landmark (lm) function (with any epm supported pattern) and then enters titration mode. in either single or multiple spot titration patterns, the power output upon pressing the footswitch is the same as the epm power. the epm power is a percentage of the power selected in the epm control. the user would expect the power output during titration to be equal to 100% of the selected power level and may increase the power level during the titration process. when the expected tissue response is not observed, the power level resulting from titration will produce an over-power treatment when the user subsequently treats with the titration turned off.
  • Action
    Software to be upgraded

Device

Topcon Pascal Synthesis and Pascal Synthesis TwinStar (only with EpM software enabled)
  • Model / Serial
    Model: , Affected: , Software version: 1.0.0, 1.0.1, 2.0.0, 3.1.1, 3.2.0, 3.3.0, 3.3.1 and 3.3.2) and 1.0.0, 1.0.1, 2.0.0, 3.1.1, 3.2.0, 3.3.0, 3.3.1 and 3.3.2)
  • Manufacturer
    Topcon Medical Laser Systems Inc

Manufacturer

Topcon Medical Laser Systems Inc