20 Diopter Binocular Indirect Ophthalmoscope (BIO) Lens For visualization during diagnosis and laser therapy of the human retina (fundus) using a binocular indirect ophthalmoscope.
FDA Recall Z-0966-2013 · Posted 2013-03-18
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Recalling FirmVolk Optical Inc
Recall StatusTerminated
Product CodeHJL
Date Initiated2012-10-25
Date Terminated2013-06-11
Product Quantity40 devices
Reason for Recall
The defect was with mis-engraving of the lot # directly on the product and its packaging. Mixed up device engraving of V20LC (lot # BB09213) with that from V60C (lot # BB09205).
Firm Action
Volk sent a Voluntary Medical Device Field Correction letter dated October 25, 2012, to all affected customers. The letter identifed the product, the problem, and the action to be taken by the customer. Customers were asked to correct their records with the correct lot number and to notify their customers of the voluntary field correction and request their compliance in updating their records. For questions customers were instructed to call 440-510-0800 or 440-942-6161.
For questions regarding this recall call 440-942-6161.
Root Cause
Employee error
Distribution Pattern
Worldwide Distribution - USA including the states of AZ, CA, GA, MN, NJ, and NM. Internationally to Japan.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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