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

FDA device recall Z-1710-2009 · posted 2009-07-21 · Terminated

Recall details

Recalling firm

Volk Optical Inc

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.'

Action taken

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 .

Root cause

Process design

Status

Terminated

Product code

HKS

Quantity affected

15

Distribution

Worldwide Distribution -- Great Britain, China and the U.S.

Date initiated

2008-06-30

Date posted

2009-07-21

Date terminated

2012-03-09

Location

Mentor, OH