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
    95185
  • Event Risk Class
    II
  • Event Initiated Date
    2012-08-08
  • 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
    The directions for use will be revised to include the following information: -clarification that the acrysof cachet phakic lens is indicated for use for the correction of myopia between -6.0 d and -16.5 d. -additional information regarding the risk of early acute endothelial cell loss (ecl) to strengthen communication of benefits and risks of implantation to the patient. -clarification on the frequency of monitoring for ecl by specular microscopy. the new recommendation is applicable for post-operative follow-up at one month three months and six months and then at six-month intervals in collaboration with the treating physician. -data on patients who experienced a greater than 30% endothelial cell loss (when compared to the preoperative cell count) and/or count below 1500 cells/mm2 in the clinical studies.

Device

ACRYSOF CACHET PHAKIC LENS
  • Model / Serial
    Model Catalog: L14000 (Lot serial: ALL LOTS); Model Catalog: L13500 (Lot serial: ALL LOTS); Model Catalog: L13000 (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