20 Diopter Binocular Indirect Ophthalmoscope (BIO) Lens For visualization during diagnosis and...

FDA Device Recall #Z-0966-2013 — Class III — October 25, 2012

Recall Summary

Recall Number Z-0966-2013
Classification Class III — Low risk
Date Initiated October 25, 2012
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Volk Optical Inc
Location Mentor, OH
Product Type Devices
Quantity 40 devices

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).

Distribution Pattern

Worldwide Distribution - USA including the states of AZ, CA, GA, MN, NJ, and NM. Internationally to Japan.

Lot / Code Information

Product Code: V20LC; Lot/Serial Numbers: BB09213 & BB09205

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-2055-2015 Class III Lombart 90D Clear with case Visualization duri... Feb 27, 2015

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.