Events

Recall of CUSTOM-PAK OPHTHALMIC SURGERY PROCEDURE PACK

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
    42410
  • Event Risk Class
    III
  • Event Initiated Date
    2017-02-22
  • 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
    Advisory notice to alcon custom pak(r) customers. becton dickinson (bd) has indicated that it has received reports of safety cover disengagement and needlestick injury (nsi) for its bd eclipse needle. since these needles are supplied in alcon custom paks alcon will be forwarding bd advisory notice information to alcon customers.

Device

CUSTOM-PAK OPHTHALMIC SURGERY PROCEDURE PACK
  • Model / Serial
    Model Catalog: 00000-00 TO 99999-99 (Lot serial: ALL LOTS); Model Catalog: 0000-00 (Lot serial: ALL LOTS)
  • Product Description
    CUSTOM-PAK OPHTHALMIC SURGERY PROCEDURE PACK CONTAINING BD ECLIPSE NEEDLE
  • Manufacturer
    ALCON CANADA INC.

Manufacturer

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