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.
FDA Recall Z-1685-2015 · Posted 2015-05-28
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Recalling FirmVolk Optical Inc
Recall StatusTerminated
Product CodeHJK
Date Initiated2015-02-27
Date Terminated2016-02-19
Product Quantity6 units
Reason for Recall
Mislabeling. The incorrect lot number was engraved on the anodized aluminum ring.
Firm 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.).
Root Cause
Process control
Distribution Pattern
Worldwide Distribution - US Distribution to the states of : MA and VA., and to the countries of Mexico and Sweden.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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