Events

Recall of Device Recall Vision One Laser System Model

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Lumenis, 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
    66133
  • Event Risk Class
    Class 2
  • Event Number
    Z-2191-2013
  • Event Initiated Date
    2013-08-19
  • Event Date Posted
    2013-09-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-12-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121534
  • 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
    Powered laser surgical instrument - Product Code GEX
  • Reason
    Lumenis has initiated a recall on certain models of vision one system due to a potential for unintended laser exposure to the user.
  • Action
    Customer's were notified via letter on 8/19/13. Service visits to consignees were scheduled with anticipated completion on 8/26/13 to replace the control board. Consignee monitoring was performed by use of return reply verification tracking cards returned by the Lumenis service engineer after completion of CPU board replacement.

Device

Device Recall Vision One Laser System Model
  • Model / Serial
    Model: GA-0025020
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in the states of NJ, PA, and IL.
  • Product Description
    Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. || Intended for use in the treatment of ocular pathology.
  • Manufacturer
    Lumenis, Inc.

Manufacturer

Lumenis, Inc.
  • Manufacturer Address
    Lumenis, Inc., 3959 W 1820 S, Salt Lake City UT 84104
  • Manufacturer Parent Company (2017)
    Laguna Holdco Ltd
  • Source
    USFDA