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U.S. Department of Health and Human Services

Class 3 Device Recall Volk G4 Small Ring, No Flange, Gonio Lens with case

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  Class 3 Device Recall Volk G4 Small Ring, No Flange, Gonio Lens with case see related information
Date Initiated by Firm February 02, 2016
Date Posted March 15, 2016
Recall Status1 Terminated 3 on April 26, 2017
Recall Number Z-1177-2016
Recall Event ID 73213
Product Classification Lens, contact, polymethylmethacrylate, diagnostic - Product Code HJK
Product Volk G-4 Small Ring, No Flange, Gonio Lens with case, UPC: 811608013602
for use as diagnostic contact lenses for eye examinations (including the anterior chamber, trabecular meshwork, central retina, and peripheral retina) and use in the therapy of intraocular abnormalities
Code Information Model #: VG4SNF, Lot: BE05200
Recalling Firm/
Manufacturer		 Volk Optical Inc
7893 Enterprise Dr
Mentor OH 44060-5309
For Additional Information Contact Ms. Meghan M. Leonard
440-510-0745
Manufacturer Reason
for Recall		 The firm discovered that the incorrect lot number was engraved on the product.
FDA Determined
Cause 2		 Employee error
Action Volk Optical sent an Urgent Medical Device Recall letter dated February 4, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately examine their inventory and quarantine any affected product. Also, if product was further distributed customers should identify their customers and notify them at once of the product recall and include a copy of the letter. The affected devices should be returned to Volk with an assigned Return Merchandise Authorization (RMA) number. Customers should contact Volk at (440) 942-6161 or toll free at (800) 345-8655 as soon as they receive the notification to setup a RMA for their device(s). Customers were instructed to complete and return the enclosed response form as soon as possible. Customers with questions should call (440) 510-0745.
Quantity in Commerce 9 lens
Distribution Worldwide Distribution - US (Virginia only) Internationally to Canada, France & Indonesia.
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.
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