Recall Z-2055-2015— Volk Optical Inc
Class III · Terminated
Class III FDA medical device recall by Volk Optical Inc, initiated 2015-02-27, terminated 2016-02-04. FDA's recall record names no specific 510(k) clearance for this event. Product: Lombart 90D Clear with case Visualization during diagnosis and laser therapy of the human retina (fundus) using a slit lamp.. Reason: 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..
- Recalling firm
- Volk Optical Inc
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2015-02-27
- Terminated
- 2016-02-04
- Firm location
- Mentor, OH, United States
Product description
Lombart 90D Clear with case Visualization during diagnosis and laser therapy of the human retina (fundus) using a slit lamp.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.