Events

Recall of Device Recall OPTICAL BIOMETER

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
    74595
  • Event Risk Class
    Class 2
  • Event Number
    Z-2587-2016
  • Event Initiated Date
    2016-07-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-12-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148011
  • 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
    Biomicroscope, slit-lamp, ac-powered - Product Code HJO
  • Reason
    Nidek inc. received information from our manufacturer nidek co. japan that the shown axial lengths were much shorter at al-scan measurement.
  • Action
    Dear Doctor/Recall letters were sent to affected customers on July 7, 2016. The letters describe the issue and provide instruction should the issue occur. The letters inform users that Nidek will reach out in the next few weeks to schedule installation of new software that will solve the problem. Questions or concerns may be directed to: Customer Service 1.800.722.0219; Monday- Friday 8 am to 5pm PST E-mail: AL-Scan_support@noritsuservice.com.

Device

Device Recall OPTICAL BIOMETER
  • Model / Serial
    OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier. Serial numbers: 220005, 220006, 220008, 220009, 220013, 220017, 220018, 220019, 220020, 220021, 220023, 220025, 220026, 220031, 220032, 220033, 220036.
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution in the states of: NY, PA. GA. AZ, VA, DE, ME,. MO, TN, and NM.
  • Product Description
    OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier. || Ophthalmic: The OPTICAL BIOMETER AL-Scan is a measuring device that can measure as a single unit the values necessary to calculate the power of an IOL for cataract surgery such as axial length, corneal curvature radius, and anterior chamber depth. It measures these necessary values successively through a non-contact optical measurement method.
  • 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