Events

Recall of AcrySof CACHET Phakic Lens (Used for the reduction or elimination of myopia)

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-2013-RN-00300-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-04-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00300-1
  • 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
    This action is an update to the previous ‘urgent recall for product correction' and 'hazard alert' letters issued by alcon in february 2012 and july 2012 for the acrysof cachet phakic lens that described updates to the directions for use (dfu) and advised healthcare professionals of an acute adverse event for endothelial cell loss (ecl). recently alcon conducted a further data analyses of the five-year global study looking at the safety and efficacy of the acrysof cachet phakic lens. whilst the study data showed high efficacy as defined by visual acuity, approximately 1% of implanted lenses showed a risk for accelerated corneal endothelial cell loss (ecl) that led to explantation of the lens. the cause of ecl in individual patients is not well understood and is likely multi-factorial. however, analyses have indicated a trend for higher rates of ecl in:- patients with smaller eyes (those implanted with lens model l12500) - patients self-identified as being asians.
  • Action
    Alcon is revising Directions for Use (DFU) with: - updated clinical data to include results from 5 year clinical studies - strengthen language to require (endothelial cell density (ECD) assessment of every 6 months - provide guidelines for endothelial cell monitoring For patients with the AcrySof CACHET Phakic Lenses already implanted, Alcon is recommending surgeons to remind the patients of the risks associated with undetected ECL and also, discuss the need for strict compliance with the monitoring requirements endothelial cell density ie, monitoring every six months) per the current version of the Directions for Use (DFU). Strict adherence to these requirements by patients will help to timely identify ECL and determine the appropriate treatment plan.

Device

AcrySof CACHET Phakic Lens (Used for the reduction or elimination of myopia)

Manufacturer

Alcon Laboratories Australia Pty Ltd