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U.S. Department of Health and Human Services

Class 3 Device Recall 20 Diopter Binocular Indirect Ophthalmoscope (BIO) Lens

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 Class 3 Recall
20 Diopter Binocular Indirect Ophthalmoscope (BIO) Lens
see related information
Date Posted March 18, 2013
Recall Status1 Terminated on June 11, 2013
Recall Number Z-0966-2013
Recall Event ID 64410
Product Classification Lens, Condensing, Diagnostic - Product Code HJL
Product 20 Diopter Binocular Indirect Ophthalmoscope (BIO) Lens For visualization during diagnosis and laser therapy of the human retina (fundus) using a binocular indirect ophthalmoscope.
Code Information Product Code: V20LC; Lot/Serial Numbers: BB09213 & BB09205
Recalling Firm/
Manufacturer
Volk Optical Inc
7893 Enterprise Dr
Mentor, Ohio 44060-5309
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Jacob Iselin
440-942-6161
Manufacturer 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).
FDA Determined
Cause 2
TRAINING: Employee Error
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.
Quantity in Commerce 40 devices
Distribution Worldwide Distribution - USA including the states of AZ, CA, GA, MN, NJ, and NM. Internationally to Japan.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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