Events

Recall of Device Recall Lombart 90D Clear with case

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Volk Optical 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
    71048
  • Event Risk Class
    Class 3
  • Event Number
    Z-2055-2015
  • Event Initiated Date
    2015-02-27
  • Event Date Posted
    2015-07-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-02-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135924
  • 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
    Lens, fundus, hruby, diagnostic - Product Code HJI
  • Reason
    Mislabeling. the incorrect lot number was engraved on the anodized aluminum ring. the correct lot number is be03356; however, bd03356 was engraved on the ring in error.
  • Action
    Volk Optical sent a Medical Device Recall letter on March 30, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory and quarantine the affected product. If product was further distributed customers need to identify their customers and notify them at once. Customers were instructed to return the affected device for replacement. Customers with questions were instructed to contact Volk at 440-942-6161 or toll free at 800-345-8655. For questions regarding this recall call 440-510-0745.

Device

Device Recall Lombart 90D Clear with case
  • Model / Serial
    Model: L90C, Lot: BE03356.
  • Product Classification
    Ophthalmic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distribution to VA only
  • Product Description
    Lombart 90D Clear with case || Visualization during diagnosis and laser therapy of the human retina (fundus) using a slit lamp.
  • Manufacturer
    Volk Optical Inc

Manufacturer

Volk Optical Inc
  • Manufacturer Address
    Volk Optical Inc, 7893 Enterprise Dr, Mentor OH 44060-5309
  • Manufacturer Parent Company (2017)
    Halma Plc
  • Source
    USFDA