Events

Recall of 20 Diopter Binocular Indirect Ophthalmoscope (BIO) Lens

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
    64410
  • Event Risk Class
    Class 3
  • Event Number
    Z-0966-2013
  • Event Initiated Date
    2012-10-25
  • Event Date Posted
    2013-03-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-06-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116075
  • 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, condensing, diagnostic - Product Code HJL
  • Reason
    The defect was with mis-engraving of the lot # directly on the product and its packaging. mixed up device engraving of v20lc (lot # bb09213) with that from v60c (lot # bb09205).
  • Action
    Volk sent a Voluntary Medical Device Field Correction letter dated October 25, 2012, to all affected customers. The letter identifed the product, the problem, and the action to be taken by the customer. Customers were asked to correct their records with the correct lot number and to notify their customers of the voluntary field correction and request their compliance in updating their records. For questions customers were instructed to call 440-510-0800 or 440-942-6161. For questions regarding this recall call 440-942-6161.

Device

20 Diopter Binocular Indirect Ophthalmoscope (BIO) Lens
  • Model / Serial
    Product Code: V20LC; Lot/Serial Numbers: BB09213 & BB09205
  • Product Classification
    Ophthalmic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including the states of AZ, CA, GA, MN, NJ, and NM. Internationally to Japan.
  • Product Description
    20 Diopter Binocular Indirect Ophthalmoscope (BIO) Lens || For visualization during diagnosis and laser therapy of the human retina (fundus) using a binocular indirect ophthalmoscope.
  • 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