Events

Recall of Nidek Excimer Laser Corneal Surgery System, model EC5000 CXIII.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Nidek 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
    69508
  • Event Risk Class
    Class 2
  • Event Number
    Z-0223-2015
  • Event Initiated Date
    2012-08-06
  • Event Date Posted
    2014-11-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-11-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130780
  • 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
    Contact failure in f1 and f4 fuse holders was detected on the ec-5000 cxiii excimer laser corneal surgery system that could cause a serious adverse event for the patient.
  • Action
    Nidek Engineers visited each site to perform correction - fuse holders have been inspected and replaced if necessary. An Engineering Change Order was issued on June 1, 2012, for inspection and/or replacement of affected fuse holders by Nidek Service Engineers. For further questions please call (510) 353-7785.

Device

Nidek Excimer Laser Corneal Surgery System, model EC5000 CXIII.
  • Model / Serial
    Serial numbers: 530054 530055 530070 530073 530078 530082 530086 530087 530098 530106 530121 530123 530150 530155
  • Product Classification
    Ophthalmic Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    US Distribution including the states of CO, NY, MO, LA, ME, CA, MI, AZ, CT and FL.
  • Product Description
    Nidek Excimer Laser Corneal Surgery System, model EC-5000 CXIII. || Opthalmic Device. The system is composed as a laser generator which produces an excimer laser radiation of wavelength 193nm, a beam delivery unit, an optical system for observation, a gas system and a computer for system control.
  • Manufacturer
    Nidek Inc

Manufacturer

Nidek Inc
  • Manufacturer Address
    Nidek Inc, 47651 Westinghouse Dr, Fremont CA 94539-7474
  • Manufacturer Parent Company (2017)
    Nidek Co. Ltd.
  • Source
    USFDA