Events

Recall of Device Recall LADAR6000

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Alcon Refractive Horizons, 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
    37605
  • Event Risk Class
    Class 1
  • Event Number
    Z-0854-2007
  • Event Initiated Date
    2007-02-21
  • Event Date Posted
    2007-06-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51005
  • 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
    Excimer Laser System - Product Code LZS
  • Reason
    Observed 'central islands' in patients following custom myopia laser procedures using the ladar6000 excimer laser. (on may 11, 2007, alcon notified consignees that the device software programs for customcornea myopia and customcornea myopia with astigmatism of the device would be deactivated).
  • Action
    Consignees were notified of the recall via two letters. On Feb. 21, 2007, consignees were requested to immediately stop performing all custom cornea myopia procedures and to return an acknowledgement card indicating they have received the alert and understand the required actions. On May 11, 2007, Alcon notified consignees that the device software programs for CustomCornea Myopia and CustomCornea Myopia with Astigmatism of the device would be deactivated. After meeting with CDRH's Office of Compliance on August 27, 2007, the recalling firm committed to total product removal of the device. Notification will begin in Sept 2007 and will be made by personal visits to each consignee.

Device

Device Recall LADAR6000
  • Model / Serial
    All serial/lot numbers of the LADAR6000
  • Product Classification
    Ophthalmic Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-including USA, Czech Republic, Spain, Australia, Italy, Hong Kong, Vietnam, Singapore, South Korea, and Canada
  • Product Description
    LADAR6000 Excimer Laser System
  • Manufacturer
    Alcon Refractive Horizons, Inc.

Manufacturer

Alcon Refractive Horizons, Inc.
  • Manufacturer Address
    Alcon Refractive Horizons, Inc., 2800 Discovery Dr, Orlando FL 32826-3010
  • Source
    USFDA