Class 3 Device Recall Standard Gonio Lens

• Date Initiated by Firm: June 30, 2008
• Date Posted: July 21, 2009
• Recall Status: Terminated on March 09, 2012
• Recall Number: Z-1710-2009
• Recall Event ID: 52453
• Product Classification: Prism, gonioscopic - Product Code HKS
• Product: G-4 HighMag Flange, Model #VG4HM. Standard Gonio Lens for High Magnification Static and Dynamic Gonioscopy.
• Code Information: The device was identified with the Lot Code: A1050030.
• Recalling Firm/ Manufacturer: Volk Optical Inc; 7893 Enterprise Dr; Mentor OH 44060-5309
• For Additional Information Contact: 440-942-6161
• Manufacturer 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.'
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.