Algerbrush-II Product Usage: Medical - For surgeons to use in ophthalmic surgical procedures ...
FDA Device Recall #Z-0983-2017 — Class II — October 12, 2016
Recall Summary
| Recall Number | Z-0983-2017 |
| Classification | Class II — Moderate risk |
| Date Initiated | October 12, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Bausch & Lomb, Inc. |
| Location | Lynchburg, VA |
| Product Type | Devices |
| Quantity | 2487 units Domestic (USA), 1,211 units Foreign (outside USA) |
Product Description
Algerbrush-II Product Usage: Medical - For surgeons to use in ophthalmic surgical procedures to remove foreign bodies from the eye of the patient
Reason for Recall
According to firm ( Bausch & Lomb, Inc. ) on June 17, 2016 a packaging operator notified his supervisor he had not placed the operating instruction into the last repackaging of SKU 0816 C (Pterygium Burr Medium Diamond). Further investigation found that repackaged Algerbrush-II and its accessories from April 30, 2012 to present, contained out of date operating instruction. Therefore Bausch & Lomb is proposing a Field Correction to provide customer purchasing product from April 30, 2012 to June 20, 2016 with the current operating instruction.
Distribution Pattern
Worldwide Distribution - US Nationwide
Lot / Code Information
LOT #(s) AND EXPIRATION DATES, SERIAL #(s), ORDER #, or OTHER IDENTIFICATION #(s): SKU E0815 A, SKU E0815 B, SKU E0815 0.5, SKU E0815 1.0 and SKU E0816 C
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.