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Terminated

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

FDA Recall Z-1710-2009 · Posted 2009-07-21

Recalling FirmVolk Optical Inc
Recall StatusTerminated
Product CodeHKS
Date Initiated2008-06-30
Date Terminated2012-03-09
Product Quantity15

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.'

Firm 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 .

Root Cause

Process design

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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