FDA Medical Device Recalls (openFDA)
Volk Optical Inc: G-4 HighMag Flange, Model #VG4HM. Standard Gonio Lens for High Magnification Static and Dynamic Gonioscopy.
- Recall number
- Z-1710-2009
- Recalling firm
- Volk Optical Inc
- Product
- G-4 HighMag Flange, Model #VG4HM. Standard Gonio Lens for High Magnification Static and Dynamic Gonioscopy.
- Status
- Terminated
- Initiated
- 2008-06-30
- Posted
- 2009-07-21
- Terminated
- 2012-03-09
- Reason
- 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
- 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
- 15
- Distribution
- Worldwide Distribution -- Great Britain, China and the U.S.
- Lot, serial or model codes
- The device was identified with the Lot Code: A1050030.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HKS
- Firm FEI
- 1000122772
- Firm city
- Mentor
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28