Events

Recall of ORA SYSTEM 2000 INTRAOPERTIVE WAVEFRONT ABERROMETER

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
    151779
  • Event Risk Class
    II
  • Event Initiated Date
    2017-07-13
  • 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
    Through remote monitoring of the intraocular lens (iol) databases on installed ora carts alcon has determined that that a small number of ora carts have the potential to return an incorrect iol power measurement during cataract surgery.

Device

ORA SYSTEM 2000 INTRAOPERTIVE WAVEFRONT ABERROMETER
  • Model / Serial
    Model Catalog: ORA SYSTEM 2000 (Lot serial: C4286R); Model Catalog: 00380659983078 (Lot serial: C4239R); Model Catalog: ORA SYSTEM 2000 (Lot serial: 1601274801X1); Model Catalog: 00380659983078 (Lot serial: 1601274801X1); Model Catalog: ORA SYSTEM 2000 (Lot serial: 1601320201X1); Model Catalog: 00380659983078 (Lot serial: 1601320201X1); Model Catalog: ORA SYSTEM 2000 (Lot serial: 1601321601X); Model Catalog: 00380659983078 (Lot serial: 1601321601X); Model Catalog: ORA SYSTEM 2000 (Lot serial: 1601321301X); Model Catalog: 00380659983078 (Lot serial: 1601321301X); Model Catalog: ORA SYSTEM 2000 (Lot serial: 1603716401X); Model Catalog: 00380659983078 (Lot serial: 1603716401X); Model Catalog: ORA SYSTEM 2000 (Lot serial: 1601321001X); Model Catalog: 00380659983078 (Lot serial: 1601321001X); Model Catalog: ORA SYSTEM 2000 (Lot serial: C4239R); Model Catalog: 00380659983078 (Lot serial: C4286R)
  • Product Description
    ORA SYSTEM 2000 INTRAOPERTIVE WAVEFRONT ABERROMETER
  • Manufacturer
    ALCON CANADA INC.

Manufacturer

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