FDA-Device2015-07-15Class III
Lombart 90D Clear with case Visualization during diagnosis and laser therapy of the human retina (fundus) using a slit lamp.
Volk Optical Inc
Hazard
Mislabeling. The incorrect lot number was engraved on the anodized aluminum ring. The correct lot number is BE03356; however, BD03356 was engraved on the ring in error.
Sold states
Distribution to VA only
Affected count
78 units
Manufactured in
7893 Enterprise Dr, N/A, Mentor, OH, United States
Products
Lombart 90D Clear with case Visualization during diagnosis and laser therapy of the human retina (fundus) using a slit lamp.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2055-2015Don't want to check this manually?
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