Z-0966-2013Class III

20 Diopter Binocular Indirect Ophthalmoscope (BIO) Lens For visualization during diagnosis and laser therapy...

Name: Z-0966-2013 20 Diopter Binocular Indirect Ophthalmoscope (BIO) Lens For visualization during diagnosis and laser therapy...
Creator: Volk Optical Inc
Published: 2012-10-25
License: https://open.fda.gov/license/

Volk Optical Inc / initiated 2012-10-25 / Terminated / root cause: manufacturing process

FDA source

Volk Optical Inc began a recall of 20 Diopter Binocular Indirect Ophthalmoscope (BIO) Lens For visualization during diagnosis and laser therapy of the human retina (fundus) using a binocular... on 2012-10-25. FDA classified it as Class III and gives the reason as "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)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0966-2013
Classification: Class III
Status: Terminated
Initiated: 2012-10-25
Posted: 2013-03-18
Terminated: 2013-06-11
Recalling firm: Volk Optical Inc
Product: 20 Diopter Binocular Indirect Ophthalmoscope (BIO) Lens For visualization during diagnosis and laser therapy of the human retina (fundus) using a binocular indirect ophthalmoscope.
Product code: HJL Lens, Condensing, Diagnostic
Reason for recall: 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).
Root cause tag: manufacturing process
FDA root cause: Employee error
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.
Quantity in commerce: 40 devices
Distribution: Worldwide Distribution - USA including the states of AZ, CA, GA, MN, NJ, and NM. Internationally to Japan.
Product codes and lots: Product Code: V20LC; Lot/Serial Numbers: BB09213 & BB09205

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0966-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0966-2013	Class III	Terminated	Voluntary: Firm initiated	2013-03-27	2013-03-18

Product code HJL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)