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U.S. Department of Health and Human Services

Class 3 Device Recall Standard Gonio Lens

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  Class 3 Device Recall Standard Gonio Lens see related information
Date Initiated by Firm June 30, 2008
Date Posted July 21, 2009
Recall Status1 Terminated 3 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/
Volk Optical Inc
7893 Enterprise Dr
Mentor OH 44060-5309
For Additional Information Contact
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 2
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.