Events

Recall of Device Recall Fixed eye Safety filters

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Laserex Systems 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
    73468
  • Event Risk Class
    Class 2
  • Event Number
    Z-1270-2016
  • Event Initiated Date
    2016-02-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-10-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144247
  • 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
    Laser, ophthalmic - Product Code HQF
  • Reason
    The firm discovered that there is a design error which is traceable back to 2012 when a design change on the safety filter optic adaptor was implemented.
  • Action
    Ellex Medical Pty Ltd. Planned Action to bring into Compliance: 1.Field Corrective Action replacing all affected safety filters of all units manufactured between July 2012 and February 2016, 2.All repairs will be made at no cost to the purchaser; and 3.The corrections will be completed by March 30, 2017. CDRH approves the CAP subject to the following conditions: Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. For further questions please call (800) 824-7444.

Device

Device Recall Fixed eye Safety filters
  • Model / Serial
    Model Number : 3143270
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Distribution
  • Product Description
    Ellex Medical Fixed eye Safety filters Model Integre S LP5532. || The filter is located in the binocular mount of the laser delivery head. The filter prevents transmission of treatment laser light to physician eyes while the aiming beam to remain visible. || .
  • Manufacturer
    Laserex Systems Inc.

Manufacturer

Laserex Systems Inc.
  • Manufacturer Address
    Laserex Systems Inc., 7138 SHADY OAK RD, EDEN PRAIRIE MN 55344-3517
  • Source
    USFDA