Events

Recall of AcrySof CACHET PHAKIC Lens

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-2014-RN-01013-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-09-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01013-1
  • 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 are discontinuing the cachet phakic lens based on data analysis from an ongoing 10-year study to evaluate the safety of the cachet phakic lens in patients with myopia (near-sightedness) from -6.0 to -16.5 d vision correction. the clinical data analysis indicates an increase in the number of cases of endothelial cell loss (ecl). in the clinical study, patients’ endothelial cell density (ecd) levels are monitored at 6 month intervals, as recommended by the current cachet phakic lens directions for use (dfu). to date, only 2.7% of the 1,323 cachet phakic lenses implanted in the clinical study were explanted due to ecl.
  • Action
    If you have inventory of the CACHET Phakic Lens, these lenses can be returned to Alcon for reimbursement. Patients with the CACHET Phakic Lenses already implanted, Alcon is recommending opthamologists adhere to the monitoring requirements described in the current DFU. Adherence to these requirements will help to timely identify significant ECL and determine the appropriate treatment plan. For more details, please see http://www.tga.gov.au/safety/alerts-device-acrysof-cachet-phakic-lens-140924.htm .

Device

AcrySof CACHET PHAKIC Lens

Manufacturer

Alcon Laboratories Australia Pty Ltd