Events

Field Safety Notices about LX3 Microscope Floor Stand

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Alcon Eye Care UK Limited.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2017-06-01
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Extra notes in the data
  • Reason
    Alcon has observed that multiple shipments or forceful impact to a caster on a luxor/lx3 microscope may stress the microscope base, which could contribute to a caster breaking or detaching from the base. during in-facility transfer, should a caster break or detach from the base while the microscope arm is not in the most inward locked position (as shown in figure 1), the unit may tip if the microscope arm is extended (as shown in figure 2) over the location of the broken caster. this may lead to the potential for physical injury from the microscope tipping or falling. two incidents of physical injury have been reported in conjunction with this issue. as a precaution, we are voluntarily inspecting and retrofitting luxor / lx3 units with new bases and / or an updated caster configuration. .

Device

LX3 Microscope Floor Stand

Manufacturer

Alcon Eye Care UK Limited