Recall Z-0966-2013— Volk Optical Inc
Class III · Terminated
Class III FDA medical device recall by Volk Optical Inc, initiated 2012-10-25, terminated 2013-06-11. FDA's recall record names no specific 510(k) clearance for this event. Product: 20 Diopter Binocular Indirect Ophthalmoscope (BIO) Lens For visualization during diagnosis and laser therapy of the human retina (fundus) using a binocular indirect ophthalmoscope.. Reason: 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)..
- Recalling firm
- Volk Optical Inc
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2012-10-25
- Terminated
- 2013-06-11
- Firm location
- Mentor, OH, United States
Product description
20 Diopter Binocular Indirect Ophthalmoscope (BIO) Lens For visualization during diagnosis and laser therapy of the human retina (fundus) using a binocular indirect ophthalmoscope.
Reason for recall
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.