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Terminated

Lombart 90D Clear with case Visualization during diagnosis and laser therapy of the human retina (fundus) using a slit lamp.

FDA Recall Z-2055-2015 · Posted 2015-07-09

Recalling FirmVolk Optical Inc
Recall StatusTerminated
Product CodeHJI
Date Initiated2015-02-27
Date Terminated2016-02-04
Product Quantity78 units

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.

Firm Action

Volk 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.

Root Cause

Other

Distribution Pattern

Distribution to VA only

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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