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 ACUFOCUS 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
    114058
  • Event Risk Class
    III
  • Event Initiated Date
    2014-04-23
  • 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
    Acufocus is aware of reports of some cases this device being used in eyes containing karma inlays. this notice is to update customers on ophthalmic procedures with a kamra inlay in situ.

Device

KAMRA CORNEAL INLAY ACI 7000
  • Model / Serial
    Model Catalog: ACI 7000 (Lot serial: all lots)
  • Product Description
    Kamra Corneal Inlay ACI 7000
  • Manufacturer
    ACUFOCUS INC.

Manufacturer

ACUFOCUS INC.
  • Manufacturer Address
    IRVINE
  • Manufacturer Parent Company (2017)
    AcuFocus Inc.
  • Source
    HC