Reported Mar 27, 2013 · Terminated
20 Diopter Binocular Indirect Ophthalmoscope (BIO) Lens For visualization during diagnosis and laser therapy of the…
Volk Optical Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Volk Optical Inc · 7893 Enterprise Dr · Mentor, OH · 44060-5309
Is this the product you have?
- 20 Diopter Binocular Indirect Ophthalmoscope (BIO) Lens For visualization during diagnosis and laser therapy of the human retina (fundus) using a binocular indirect ophthalmoscope.
- Lot codes and dates
- Product CodeV20LC
- Lot/Serial NumbersBB09213 & BB09205
- Amount recalled
- 40 devices
Where it was sold
Why it was recalled
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).
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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