Laseredge Knife 1.5mm X 1.7mm TRAPEZOID ANGLED, REF E7599 Product Usage: Available to surgeon...

FDA Device Recall #Z-2366-2019 — Class II — July 11, 2016

Recall Summary

Recall Number Z-2366-2019
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 165 packs/6 blades (990 individiual blades)

Product Description

Laseredge Knife 1.5mm X 1.7mm TRAPEZOID ANGLED, REF E7599 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 Number: MAXZ170 Expiry Date: 01/28/2021

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.