Lombart 90D Clear with case Visualization during diagnosis and laser therapy of the human retina...
FDA Device Recall #Z-2055-2015 — Class III — February 27, 2015
Recall Summary
| Recall Number | Z-2055-2015 |
| Classification | Class III — Low risk |
| Date Initiated | February 27, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Volk Optical Inc |
| Location | Mentor, OH |
| Product Type | Devices |
| Quantity | 78 units |
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.
Distribution Pattern
Distribution to VA only
Lot / Code Information
Model: L90C, Lot: BE03356,
Other Recalls from Volk Optical Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1177-2016 | Class III | Volk G-4 Small Ring, No Flange, Gonio Lens with... | Feb 2, 2016 |
| Z-1685-2015 | Class III | Volk 25D Large Clear BIO Lens with case UPC: 8 ... | Feb 27, 2015 |
| Z-0966-2013 | Class III | 20 Diopter Binocular Indirect Ophthalmoscope (B... | Oct 25, 2012 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.