Events

Recall of Device Recall Endo Ocular Directional Laser Probe

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
    56481
  • Event Risk Class
    Class 2
  • Event Number
    Z-2652-2010
  • Event Initiated Date
    2010-07-27
  • Event Date Posted
    2010-09-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-10-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93765
  • 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
    Ophthalmic laser - Product Code HQF
  • Reason
    Firm did not have proper 510(k) clearance.
  • Action
    Lumenis sent letters to all customers on 7/27/10 instructing them to review their inventory, isolate affected product, complete a recall verification form and return all affected product to them.

Device

Device Recall Endo Ocular Directional Laser Probe
  • Model / Serial
    Model numbers: GA-0040061;, GA-0040062; GA-0040063; GA-0040064; GA-0040065 and GA-0040066 Lot numbers: 942439; 946478; 947498; 942440; 947496; 010120; and 947501
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    FL, IL, MD, CO and TX
  • Product Description
    Endo Ocular Directional Laser Probe, Lumenis Inc. Salt Lake City, UT STERILE EO
  • 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