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
    151042
  • Event Risk Class
    II
  • Event Initiated Date
    2014-09-19
  • 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
    Alcon is voluntarily 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. patients with the cachet phakic lens should continue with the ongoing monitoring and evaluation outlined in the current directions for use( dfu). in cases where an explant is warranted in accordance with the criteria set out in the attached dfu alcon will work with the treating ophthalmologist to ensure that the affected patients receive an explant without incurring out-of-pocket costs.

Device

ACRYSOF CACHET PHAKIC LENS
  • Model / Serial
    Model Catalog: L12500 (Lot serial: all lots); Model Catalog: L13000 (Lot serial: all lots); Model Catalog: L13500 (Lot serial: all lots); Model Catalog: L14000 (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