Laseredge 1.1mm Arrow Knife Angled, REF E7592 Product Usage: Available to surgeons for use in...
FDA Device Recall #Z-2365-2019 — Class II — July 11, 2016
Recall Summary
| Recall Number | Z-2365-2019 |
| Classification | Class II — Moderate risk |
| Date Initiated | July 11, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Bausch & Lomb Inc Irb |
| Location | Rochester, NY |
| Product Type | Devices |
| Quantity | 384 packs/6 blades (2,304 individual blades) |
Product Description
Laseredge 1.1mm Arrow Knife Angled, REF E7592 Product Usage: Available to surgeons for use in ophthalmic surgical procedures.
Reason for Recall
Possible dull knife edge
Distribution Pattern
US Nationwide Distribution
Lot / Code Information
Lot Numbers: MAWS530 MAXA950 Expiry Dates: 01-2021
Other Recalls from Bausch & Lomb Inc Irb
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0888-2018 | Class II | LASEREDGE Knives, 1.1MM ARROW KNIFE ANGLED (6/B... | Mar 3, 2017 |
| Z-0882-2018 | Class II | LASEREDGE Knives, 3.2MM SLIT KNIFE ANGLED (6/BO... | Mar 3, 2017 |
| Z-0864-2018 | Class II | LASEREDGE Knives, CLEAR 3.0 MM CLEAR CORNEAL AN... | Mar 3, 2017 |
| Z-0868-2018 | Class II | LASEREDGE Knives, 2.4 MM SLIT KNIFE ANGLED DOUB... | Mar 3, 2017 |
| Z-0873-2018 | Class II | LASEREDGE Knives, 2.65MM SLIT KNIFE ANGLED DOUB... | Mar 3, 2017 |
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.