Z-1685-2015Class III

Volk 25D Large Clear BIO Lens with case UPC: 8 11608 01010 6, VOLK OPTICAL INC. The Volk Optical BIO Lenses...

Name: Z-1685-2015 Volk 25D Large Clear BIO Lens with case UPC: 8 11608 01010 6, VOLK OPTICAL INC. The Volk Optical BIO Lenses...
Creator: Volk Optical Inc
Published: 2015-02-27
License: https://open.fda.gov/license/

Volk Optical Inc / initiated 2015-02-27 / Terminated / root cause: manufacturing process

FDA source

Volk Optical Inc began a recall of Volk 25D Large Clear BIO Lens with case UPC: 8 11608 01010 6, VOLK OPTICAL INC. The Volk Optical BIO Lenses are intended for visualization during diagnosis and... on 2015-02-27. FDA classified it as Class III and gives the reason as "Mislabeling. The incorrect lot number was engraved on the anodized aluminum ring". 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-1685-2015
Classification: Class III
Status: Terminated
Initiated: 2015-02-27
Posted: 2015-05-28
Terminated: 2016-02-19
Recalling firm: Volk Optical Inc
Product: Volk 25D Large Clear BIO Lens with case UPC: 8 11608 01010 6, VOLK OPTICAL INC. The Volk Optical BIO Lenses are intended for visualization during diagnosis and laser therapy of the human retina (fundus) using a binocular indirect ophthalmoscope.
Product code: HJK Lens, Contact, Polymethylmethacrylate, Diagnostic
Reason for recall: Mislabeling. The incorrect lot number was engraved on the anodized aluminum ring.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Volk Optical, Inc, sent an Urgent Medical Device Recall letter dated March 30, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The Firm requests that you return the device(s) for replacement, at our cost. The recalled device(s) should be returned to Volk with an assigned Return Merchandise Authorization (RMA) number. Please contact Volk as soon as you receive this notification to setup a RMA for your device(s). Please contact Volk at (440) 942-6161 or toll-free at (800) 345-8655 to speak with a Volk RMA Coordinator. To return a recalled device(s) to Volk, please ask Volks RMA Coordinator for the appropriate Volk shipping account number (e.g., FedEx, UPS, etc.).
Quantity in commerce: 6 units
Distribution: Worldwide Distribution - US Distribution to the states of : MA and VA., and to the countries of Mexico and Sweden.
Product codes and lots: Model #V25LC, Lot: BE09243

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1685-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1685-2015	Class III	Terminated	Voluntary: Firm initiated	2015-06-03	2015-05-28

Product code HJK

K023221Class IIContact Laser & Diagnostic LensesVolk Optical, Inc. / cleared 2002-10-11

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)