20 Diopter Binocular Indirect Ophthalmoscope recall
20 Diopter Binocular Indirect Ophthalmoscope (BIO) Lens For visualization during diagnosis and laser therapy of the human retina (fundus) using a…
Why was 20 Diopter Binocular Indirect Ophthalmoscope 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).
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?
Product Code: V20LC; Lot/Serial Numbers: BB09213 & BB09205
- Product
- 20 Diopter Binocular Indirect Ophthalmoscope (BIO) Lens For visualization during diagnosis and laser therapy of the human retina (fundus) using a…
- Recalling firm
- Volk Optical Inc
- Quantity
- 40 devices
- Distribution
- Worldwide Distribution - USA including the states of AZ, CA, GA, MN, NJ, and NM. Internationally to Japan.
- Recall date
- March 27, 2013
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)