Events

Recall of Device Recall Laser Indirect Ophthalmoscope (LIO) .

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Iridex Corporation.

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
    79386
  • Event Risk Class
    Class 2
  • Event Number
    Z-1075-2018
  • Event Initiated Date
    2018-02-27
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162191
  • 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
    It was discovered that the laser energy was not going where intended to put it, resulting in focal cataracts and iris burns.
  • Action
    Action Taken by IRIDEX: 1. A investigation was started immediately upon receipt of the returned devices from the Sloan Kettering complaint on November 3, 2017. CAPA 0125 was initiated to document the events, root cause, correction, corrective and preventive action and effectiveness of these actions. 2. A ship hold was initiated on November 15, 2017. 3.As described below, IRIDEX plans to notify customers and distributors that it is voluntarily recalling all models of the TruFocus LIO Premiere. 4. Public Warning A press release was prepared and sent out on February 23, 2018. For further questions please call (650) 962-8848 Ext. 3672

Device

Device Recall Laser Indirect Ophthalmoscope (LIO) .
  • Model / Serial
    Device Identity : 87300, 87301, 87302, 87303, 87304
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA Distribution and to the countries of : China, Germany, Australia, Canada, Ireland, Lebanon, Japan, Israel and Qatar
  • Product Description
    Iridex TruFocus LIO Premiere" Laser Indirect Ophthalmoscope ( LIO ) || The LIO is a headmounted indirect ophthalmoscope which is used with a handheld lens to view and perform laser treatments on a patient s retina. It allows binocular visualization of the peripheral retina and can be used to evaluate and treat patients.
  • Manufacturer
    Iridex Corporation

Manufacturer

Iridex Corporation
  • Manufacturer Address
    Iridex Corporation, 1212 Terra Bella Ave, Mountain View CA 94043-1824
  • Manufacturer Parent Company (2017)
    Iridex Corporation
  • Source
    USFDA