Z-2055-2015Class III

Lombart 90D Clear with case Visualization during diagnosis and laser therapy of the human retina (fundus)...

Name: Z-2055-2015 Lombart 90D Clear with case Visualization during diagnosis and laser therapy of the human retina (fundus)...
Creator: Volk Optical Inc
Published: 2015-02-27
License: https://open.fda.gov/license/

Volk Optical Inc / initiated 2015-02-27 / Terminated / root cause: labeling and UDI

FDA source

Volk Optical Inc began a recall of Lombart 90D Clear with case Visualization during diagnosis and laser therapy of the human retina (fundus) using a slit lamp 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. The correct lot number is BE03356; however, BD03356 was engraved on the ring in error". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2055-2015
Classification: Class III
Status: Terminated
Initiated: 2015-02-27
Posted: 2015-07-09
Terminated: 2016-02-04
Recalling firm: Volk Optical Inc
Product: Lombart 90D Clear with case Visualization during diagnosis and laser therapy of the human retina (fundus) using a slit lamp.
Product code: HJI Lens, Fundus, Hruby, Diagnostic
Reason for recall: 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.
Root cause tag: labeling and UDI
FDA root cause: Other
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.
Quantity in commerce: 78 units
Distribution: Distribution to VA only
Product codes and lots: Model: L90C, Lot: BE03356.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2055-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2055-2015	Class III	Terminated	Voluntary: Firm initiated	2015-07-15	2015-07-09

Product code HJI

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)