Events

Recall of LenSx Laser System with Corneal Flap Capability (used to perform corneal flaps in LASIK surgery or other treatment involving the incision of the cornea)

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-00522-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-04-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00522-1
  • 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 is conducting a recall for product correction of all lensx laser systems with corneal flap capability after receiving reports concerning incomplete corneal flap creation, which manifests as un-dissected area(s) within the side cut. if an un-dissected area in the side cut is observed, it may cause difficulty lifting the flap, potentially resulting in corneal tear, irregular stromal bed, or a corneal epithelial defect. this issue has been confirmed to manifest in only a small number of systems through the normal installation setup and optimisation process.
  • Action
    Alcon is advising users that the LenSx system can continue to be used, and to exercise professional medical judgement when determining the management of potential side cut issues. Alcon will be implementing a software upgrade in order to minimise any incomplete areas within the side cut. This action has been closed-out on 03/02/2017.

Device

LenSx Laser System with Corneal Flap Capability (used to perform corneal flaps in LASIK surgery o...
  • Model / Serial
    LenSx Laser System with Corneal Flap Capability (used to perform corneal flaps in LASIK surgery or other treatment involving the incision of the cornea)Catalogue Number: 8065998162 ARTG Number: 181017
  • Manufacturer
    Alcon Laboratories Australia Pty Ltd

Manufacturer

Alcon Laboratories Australia Pty Ltd