FDAFDA · Food and drugs·Recall number Z-0966-2013
20 Diopter Binocular Indirect Ophthalmoscope (BIO) Lens For visualization during diagnosis and laser therapy of the human retina (fundus) using a binocular indirect ophthalmoscope.
Published March 27, 2013 · Recall initiated: October 25, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Volk Optical Inc
- Distributor
- Worldwide Distribution - USA including the states of AZ, CA, GA, MN, NJ, and NM. Internationally to Japan.
- Lot
- Product Code: V20LC; Lot/Serial Numbers: BB09213 & BB09205
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.