Events

Recall of LADARVision Excimer Laser System.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Alcon Laboratories, 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
    32866
  • Event Risk Class
    Class 2
  • Event Number
    Z-1147-06
  • Event Initiated Date
    2005-08-01
  • Event Date Posted
    2006-06-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=40995
  • 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
    Alcon has identified a software error associated with the use of the measuring mode (ruler tool) on the ladarvision4000 excimer laser systems. use of this feature after alignment of the horizontal reference line will negate compensation for cyclotorsion on customcornea procedures, possibly adversely affecting clinical outcomes.
  • Action
    A Medical Device Safety Alert dated August 1, 2005, has been issued to all consignees. Each consignee was issued a Response To Safety Alert form to acknowledge receipt of the Safety Alert. A Field Service Engineer will visit to install the revised software.

Device

LADARVision Excimer Laser System.
  • Model / Serial
    CustomCornea software only. System serial numbers with prefix L4N and L4U.
  • Product Classification
    Ophthalmic Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    There have been 285 units distributed in the US and 151 units distributed to International Alcon Affiliates.
  • Product Description
    LADARVision Excimer Laser System.
  • Manufacturer
    Alcon Laboratories, Inc.

Manufacturer

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