Events

Recall of Device Recall ML7090 Microkeratome Blade

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Med-logics 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
    70348
  • Event Risk Class
    Class 2
  • Event Number
    Z-1268-2015
  • Event Initiated Date
    2015-01-13
  • Event Date Posted
    2015-03-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-10-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=133234
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Keratome, ac-powered - Product Code HNO
  • Reason
    The ml 7090 calibrated lasik blade (clb) will not fit into the amo amadeus metal blade holder.
  • Action
    The firm notified their consignees by letter on 1/13/15, sent via FedEx. The US customers were instructed to return any remaining product to MED-LOGICS and complete the response form.

Device

Device Recall ML7090 Microkeratome Blade
  • Model / Serial
    Lot 1490288
  • Product Classification
    Ophthalmic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed in the states of CA, AL, GA, and TN, and the countries of Chile and Germany.
  • Product Description
    ML 7090 Calibrated LASIK Blade (CLB); CLB CALIBRATED LASIK BLADE 10. || ML 7090 Calibrated LASIK Blade (CLB) is to be used as replacement blades for the AMO Amadeus Microkeratome, to perform lamellar keratectomy procedures.
  • Manufacturer
    Med-logics Inc

Manufacturer

Med-logics Inc
  • Manufacturer Address
    Med-logics Inc, 1627 Enterprise St, Athens TX 75751-8839
  • Manufacturer Parent Company (2017)
    Med Logics Inc
  • Source
    USFDA