Z-1177-2016Class III

Volk G-4 Small Ring, No Flange, Gonio Lens with case, UPC: 811608013602 for use as diagnostic contact lenses...

Name: Z-1177-2016 Volk G-4 Small Ring, No Flange, Gonio Lens with case, UPC: 811608013602 for use as diagnostic contact lenses...
Creator: Volk Optical Inc
Published: 2016-02-02
License: https://open.fda.gov/license/

Volk Optical Inc / initiated 2016-02-02 / Terminated / root cause: manufacturing process

FDA source

Volk Optical Inc began a recall of Volk G-4 Small Ring, No Flange, Gonio Lens with case, UPC: 811608013602 for use as diagnostic contact lenses for eye examinations (including the anterior... on 2016-02-02. FDA classified it as Class III and gives the reason as "The firm discovered that the incorrect lot number was engraved on the product". 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-1177-2016
Classification: Class III
Status: Terminated
Initiated: 2016-02-02
Posted: 2016-03-15
Terminated: 2017-04-26
Recalling firm: Volk Optical Inc
Product: Volk G-4 Small Ring, No Flange, Gonio Lens with case, UPC: 811608013602 for use as diagnostic contact lenses for eye examinations (including the anterior chamber, trabecular meshwork, central retina, and peripheral retina) and use in the therapy of intraocular abnormalities
Product code: HJK Lens, Contact, Polymethylmethacrylate, Diagnostic
Reason for recall: The firm discovered that the incorrect lot number was engraved on the product.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Volk Optical sent an Urgent Medical Device Recall letter dated February 4, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately examine their inventory and quarantine any affected product. Also, if product was further distributed customers should identify their customers and notify them at once of the product recall and include a copy of the letter. The affected devices should be returned to Volk with an assigned Return Merchandise Authorization (RMA) number. Customers should contact Volk at (440) 942-6161 or toll free at (800) 345-8655 as soon as they receive the notification to setup a RMA for their device(s). Customers were instructed to complete and return the enclosed response form as soon as possible. Customers with questions should call (440) 510-0745.
Quantity in commerce: 9 lens
Distribution: Worldwide Distribution - US (Virginia only) Internationally to Canada, France & Indonesia.
Product codes and lots: Model #: VG4SNF, Lot: BE05200

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1177-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1177-2016	Class III	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-15

Product code HJK

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)