Lombart 90D Clear with case Visualization during recall: Labeling Error
Lombart 90D Clear with case Visualization during diagnosis and laser therapy of the human retina (fundus) using a slit lamp.
Why was Lombart 90D Clear with case Visualization during 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model: L90C, Lot: BE03356,
- Product
- Lombart 90D Clear with case Visualization during diagnosis and laser therapy of the human retina (fundus) using a slit lamp.
- Recalling firm
- Volk Optical Inc
- Quantity
- 78 units
- Distribution
- Distribution to VA only
- Recall date
- July 15, 2015
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)