Z-1710-2009

G-4 HighMag Flange, Model #VG4HM. Standard Gonio Lens for High Magnification Static and Dynamic Gonioscopy

Name: Z-1710-2009 G-4 HighMag Flange, Model #VG4HM. Standard Gonio Lens for High Magnification Static and Dynamic Gonioscopy
Creator: Volk Optical Inc
Published: 2008-06-30
License: https://open.fda.gov/license/

Volk Optical Inc / initiated 2008-06-30 / Terminated / root cause: manufacturing process

FDA source

Volk Optical Inc began a recall of G-4 HighMag Flange, Model #VG4HM. Standard Gonio Lens for High Magnification Static and Dynamic Gonioscopy on 2008-06-30. The reason FDA records is "The ring of the Gonio lenses distributed was engraved as, 'G4 High Mag Gonio LNF'; however, the engraving should have read simply: 'G4 High Mag Gonio.'". 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-1710-2009
Status: Terminated
Initiated: 2008-06-30
Posted: 2009-07-21
Terminated: 2012-03-09
Recalling firm: Volk Optical Inc
Product: G-4 HighMag Flange, Model #VG4HM. Standard Gonio Lens for High Magnification Static and Dynamic Gonioscopy.
Product code: HKS Prism, Gonioscopic
Reason for recall: The ring of the Gonio lenses distributed was engraved as, 'G4 High Mag Gonio LNF'; however, the engraving should have read simply: 'G4 High Mag Gonio.'
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Volk Optical Inc. contacted their customers and notified them of affected device via E-mail, letter, and Fax transmittals starting June 30, 2008. The recall notification(s) describes the engraving error and instructs the users on steps to replace the affected product. For further questions, contact Volk Optical Inc. at 1-800-345-8655 extension 443 .
Quantity in commerce: 15
Distribution: Worldwide Distribution -- Great Britain, China and the U.S.
Product codes and lots: The device was identified with the Lot Code: A1050030.

Product code HKS

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)