LASEREDGE Knives, 0.88MM ARROW KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7593, STERILE, Rx Only ...

FDA Device Recall #Z-0889-2018 — Class II — March 3, 2017

Recall Summary

Recall Number Z-0889-2018
Classification Class II — Moderate risk
Date Initiated March 3, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Bausch & Lomb Inc Irb
Location Rochester, NY
Product Type Devices
Quantity 1,236,749 knives in total

Product Description

LASEREDGE Knives, 0.88MM ARROW KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7593, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.

Reason for Recall

The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. out of an abundance of precaution, Bausch + Lomb is voluntarily recalling all product codes SKU manufacturing without the electro-polish control and penetration force testing.

Distribution Pattern

US Nationwide Distribution

Lot / Code Information

none

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.