Reported Jul 15, 2015 · Terminated
Lombart 90D Clear with case Visualization during diagnosis and laser therapy of the human retina (fundus) using a slit…
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?
- Lombart 90D Clear with case Visualization during diagnosis and laser therapy of the human retina (fundus) using a slit lamp.
- Lot codes and dates
- ModelL90C
- LotBE03356
- Amount recalled
- 78 units
Where it was sold
Why it was recalled
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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