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U.S. Department of Health and Human Services

Class 3 Device Recall Lombart 90D Clear with case

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 Class 3 Device Recall Lombart 90D Clear with casesee related information
Date Initiated by FirmFebruary 27, 2015
Date PostedJuly 09, 2015
Recall Status1 Terminated 3 on February 04, 2016
Recall NumberZ-2055-2015
Recall Event ID 71048
Product Classification Lens, fundus, hruby, diagnostic - Product Code HJI
ProductLombart 90D Clear with case Visualization during diagnosis and laser therapy of the human retina (fundus) using a slit lamp.
Code Information Model: L90C, Lot: BE03356.
Recalling Firm/
Manufacturer		 Volk Optical Inc
7893 Enterprise Dr
Mentor OH 44060-5309
For Additional Information ContactMs. Meghan M. Leonard
440-510-0745
Manufacturer Reason
for Recall		Mislabeling. The incorrect lot number was engraved on the anodized aluminum ring. The correct lot number is BE03356; however, BD03356 was engraved on the ring in error.
FDA Determined
Cause 2		Other
ActionVolk Optical sent a Medical Device Recall letter on March 30, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory and quarantine the affected product. If product was further distributed customers need to identify their customers and notify them at once. Customers were instructed to return the affected device for replacement. Customers with questions were instructed to contact Volk at 440-942-6161 or toll free at 800-345-8655. For questions regarding this recall call 440-510-0745.
Quantity in Commerce78 units
DistributionDistribution to VA only
Total Product Life CycleTPLC 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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