Events

Recall of Device Recall OPDScan III Refractive Power/Corneal Analyzer Opthalmic

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
    71691
  • Event Risk Class
    Class 2
  • Event Number
    Z-2477-2015
  • Event Initiated Date
    2015-06-15
  • Event Date Posted
    2015-08-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-04-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138756
  • 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
    Refractometer, ophthalmic - Product Code HKO
  • Reason
    Software bug was found where there was no difference in total and corneal high-order aberrations, but differences were found in internal high-order aberrations.
  • Action
    Dear Doctor letters mailing started on July 15, 2015 - first 100. They will be mailed out as the correction is received from Nidek, Japan. Dear Doctor letter will include software upgrade kit including CD or USB, instruction for upgrade and pre-paid response card to be returned to Nidek Inc.

Device

Device Recall OPDScan III Refractive Power/Corneal Analyzer Opthalmic
  • Model / Serial
    Software versions: 1.00.08 1.05.07 1.10.01, 1.01.02 1.06.02 1.11.02, 1.02.01 1.07.01 1.12.03, 1.03.02 1.08.01 1.13.01, 1.04.03 1.09.01.
  • Product Classification
    Ophthalmic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    OPD-Scan III Refractive Power/Corneal Analyzer Opthalmic || Software versions 1.00.08 1.05.07 1.10.01, 1.01.02 1.06.02 1.11.02, 1.02.01 1.07.01 1.12.03, 1.03.02 1.08.01 1.13.01, 1.04.03 1.09.01. || Opthalmic: The OPD-Scan III is a diagnostic instrument that is indicated for use for Mapping of refractive error distribution of the eye by measurement and analysis of spherical power, cylindrical power, and cylinder axis.
  • 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