Events

Recall of ACRYSOF CACHET PHAKIC LENS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ALCON CANADA INC..

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
    108435
  • Event Risk Class
    II
  • Event Initiated Date
    2014-04-02
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    This notice is being provided to update the healthcare professionals on the actions alcon is taking concerning the alcon acrysof cachet phakic lens. this is further update to the communications alcon issued in february 2012 and july 2012 where they described updates to the directions for use (dfu) and advised healthcare professionals of an acute adverse event for endothelial cell loss (ecl). alcon is developing a plan of action to ensure that physicians have the information they need to appropriately treat and monitor patients and that patients can make an informed choice about their treatment. while this is taking place and until further guidance is issued alcon is voluntarily suspending shipment of the acrysof cachet phakic lens from their facilities. the study data showed high efficacy as defined by visual acuity but a small subset of patients (approximately 1% of implanted lenses to date) showed a risk for accelerated corneal endothelial cell loss (ecl) that led to explantation of the lens. the company is currently discussing a plan of action with the health authorities.

Device

ACRYSOF CACHET PHAKIC LENS
  • Model / Serial
    Model Catalog: L13000 (Lot serial: ALL LOTS); Model Catalog: L13500 (Lot serial: ALL LOTS); Model Catalog: L14000 (Lot serial: ALL LOTS); Model Catalog: L12500 (Lot serial: ALL LOTS)
  • Product Description
    ACRYSOF CACHET PHAKIC LENS
  • Manufacturer
    ALCON CANADA INC.

Manufacturer

ALCON CANADA INC.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Novartis Ag
  • Source
    HC