Illuminated Stepped Laser Probe Curved-for use in combination with 23G vitrectomy system Product...

FDA Device Recall #Z-2097-2021 — Class II — April 14, 2021

Recall Summary

Recall Number Z-2097-2021
Classification Class II — Moderate risk
Date Initiated April 14, 2021
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Dutch Ophthalmic USA, Inc.
Location Exeter, NH
Product Type Devices
Quantity 13 Boxes

Product Description

Illuminated Stepped Laser Probe Curved-for use in combination with 23G vitrectomy system Product Code: 7510.ALC

Reason for Recall

Barcode label extended expiration date. Barcode located at the short side of the outer box shows 2025-10-27 when scanned, while the correct expiry date is 2024-10-01

Distribution Pattern

Nationwide Distribution in the states of CA, FL, MA, and UT.

Lot / Code Information

Lot Number(s) 039406 Unique Device Identifier (UDI) 08717872016122

Other Recalls from Dutch Ophthalmic USA, Inc.

Recall # Classification Product Date
Z-2091-2021 Class II Disposable Replacement Backflush Brush Needles ... Feb 25, 2021
Z-2252-2021 Class II The device is a 25-gauge infusion line that is ... May 21, 2019

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.