Date Initiated by Firm |
October 25, 2012 |
Date Posted |
March 18, 2013 |
Recall Status1 |
Terminated 3 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 OH 44060-5309
|
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 |
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
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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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