FDA-Device2013-03-27Class III
20 Diopter Binocular Indirect Ophthalmoscope (BIO) Lens For visualization during diagnosis and laser therapy of the human retina (fundus) using a binocular indirect ophthalmoscope.
Volk Optical Inc
Hazard
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).
Sold states
Worldwide Distribution - USA including the states of AZ, CA, GA, MN, NJ, and NM. Internationally to Japan.
Affected count
40 devices
Manufactured in
7893 Enterprise Dr, N/A, Mentor, OH, United States
Products
20 Diopter Binocular Indirect Ophthalmoscope (BIO) Lens For visualization during diagnosis and laser therapy of the human retina (fundus) using a binocular indirect ophthalmoscope.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0966-2013Don't want to check this manually?
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