Events

Recall of Device Recall MC500 Multicolor Laser Photocoagulator

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
    70335
  • Event Risk Class
    Class 2
  • Event Number
    Z-1127-2015
  • Event Initiated Date
    2012-03-27
  • Event Date Posted
    2015-02-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-02-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=133156
  • 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 spot size control of the scan delivery unit of the mc-500 multicolor laser photocoagulator may turn by itself.
  • Action
    Nidek Japan issues a Engineering Change Order and Nidek reps visited affected sites to perform correction.

Device

Device Recall MC500 Multicolor Laser Photocoagulator
  • Model / Serial
    Serial numbers: 20023,20039, 20040, 20042, 20047, 20049, 20050, 20051, 20052, 20062, 20063, 20064, 20066, 20067, 20068, 20076
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution- including the states of CA, MI, NY, IL, NH, KS, NY, UT, IA, WI, TX, and FL.
  • Product Description
    MC-500 Multicolor Laser Photocoagulator; || Indicated for use in retinal photocoagulation for treatment of ocular fundus diseases like diabetic retinopathy, age-related macular degeneration, retinopathy of prematurity and retinal detachment.
  • 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