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U.S. Department of Health and Human Services

Class 3 Device Recall Volk 25D Large Clear BIO Lens with case UPC: 8 11608 01010 6.

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  Class 3 Device Recall Volk 25D Large Clear BIO Lens with case UPC: 8 11608 01010 6. see related information
Date Initiated by Firm February 27, 2015
Date Posted May 28, 2015
Recall Status1 Terminated 3 on February 19, 2016
Recall Number Z-1685-2015
Recall Event ID 71014
510(K)Number K023221  
Product Classification Lens, contact, polymethylmethacrylate, diagnostic - Product Code HJK
Product Volk 25D Large Clear BIO Lens with case UPC: 8 11608 01010 6, VOLK OPTICAL INC. The Volk Optical BIO Lenses are intended for visualization during diagnosis and laser therapy of the human retina (fundus) using a binocular indirect ophthalmoscope.
Code Information Model #V25LC, Lot: BE09243
Recalling Firm/
Volk Optical Inc
7893 Enterprise Dr
Mentor OH 44060-5309
For Additional Information Contact Ms. Meghan M. Leonard
Manufacturer Reason
for Recall
Mislabeling. The incorrect lot number was engraved on the anodized aluminum ring.
FDA Determined
Cause 2
Process control
Action Volk Optical, Inc, sent an Urgent Medical Device Recall letter dated March 30, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The Firm requests that you return the device(s) for replacement, at our cost. The recalled device(s) should be returned to Volk with an assigned Return Merchandise Authorization (RMA) number. Please contact Volk as soon as you receive this notification to setup a RMA for your device(s). Please contact Volk at (440) 942-6161 or toll-free at (800) 345-8655 to speak with a Volk RMA Coordinator. To return a recalled device(s) to Volk, please ask Volks RMA Coordinator for the appropriate Volk shipping account number (e.g., FedEx, UPS, etc.).
Quantity in Commerce 6 units
Distribution Worldwide Distribution - US Distribution to the states of : MA and VA., and to the countries of Mexico and Sweden.
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.
510(K) Database 510(K)s with Product Code = HJK and Original Applicant = VOLK OPTICAL, INC.