Events

Recall of VERION Reference Unit (Vision Planner) - used with the Alcon LenSx Laser System (Surgery planning system for ophthalmic surgery)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Alcon Laboratories Australia Pty 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
    RC-2016-RN-00255-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-03-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00255-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Alcon has received reports concerning the inclusion of unplanned arcuate incisions on printed, saved (.Pdf) or exported surgical plans. this situation only occurs when the verion reference unit (vision planner) is used to create a surgical plan for non-alcon toric intraocular lenses (iols) that is used with the alcon verion digital marker lensx laser system. surgical plans for alcon toric iols as well as all spherical iol regardless of brand are not affected. these unintentional surgical plan arcuates can occur if the deactivated ‘iol 100% – ri 0%’ slider bar is unintentionally activated by the user in the planning software. this directs the software to include the addition of arcuates for the surgical procedure and can only be seen on the exported, saved (.Pdf) or printed surgical plans. if the additional arcuates are performed this may lead to an astigmatism overcorrection resulting in reduced unaided visual acuity.
  • Action
    Alcon is providing users with work around instructions to follow as an interim measure. A software update will be installed on all affected systems as a permanent fix.

Device

VERION Reference Unit (Vision Planner) - used with the Alcon LenSx Laser System (Surgery planning...
  • Model / Serial
    VERION Reference Unit (Vision Planner) - used with the Alcon LenSx Laser System (Surgery planning system for ophthalmic surgery)Catalogue Number: 8065998240ARTG Number: 214732
  • Manufacturer
    Alcon Laboratories Australia Pty Ltd

Manufacturer

Alcon Laboratories Australia Pty Ltd