Events

Recall of KAMRA CORNEAL INLAY ACI 7000

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by LABTICIAN OPHTHALMICS 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
    93497
  • Event Risk Class
    III
  • Event Initiated Date
    2016-02-11
  • 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
    Due to a secondary processing which occurred during the manufacture of these units an incorrect shelf life was assigned to the product. the incorrect labelled expiry date does not pose a patient safety risk based on data available however in an abundance of caution acufocus is retrieving the two (2) lots of kamra inlays from the market. no other lots of kamra inlays manufactured and distributed by acufocus are affected by this recall action.

Device

KAMRA CORNEAL INLAY ACI 7000
  • Model / Serial
    Model Catalog: ACI 7000 (Lot serial: A534-1014); Model Catalog: ACI 7000 (Lot serial: A535-1014)
  • Product Description
    KAMRA CORNEAL INLAY ACI 7000
  • Manufacturer
    LABTICIAN OPHTHALMICS INC.

Manufacturer

LABTICIAN OPHTHALMICS INC.