Disposable 25GA Vitrectomy Cutter, REF NGP0025, RX Only, Abbott Medical Optics Inc., The pro...

FDA Device Recall #Z-1893-2019 — Class II — September 24, 2018

Recall Summary

Recall Number Z-1893-2019
Classification Class II — Moderate risk
Date Initiated September 24, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Johnson & Johnson Surgical Vision Inc
Location Santa Ana, CA
Product Type Devices
Quantity 392 units

Product Description

Disposable 25GA Vitrectomy Cutter, REF NGP0025, RX Only, Abbott Medical Optics Inc., The product provides the item necessary to perform one vitrectomy procedure. It is used to remove vitreous from the eye. It has been designed as a disposable (single use)

Reason for Recall

Packaging error, 20GA Vitrectomy Cutter may be found in a 25GA package. Use of a Vitrectomy cutter that is a different size than expected could lead to the need to alter the surgical technique, including corneal incision enlargement.

Distribution Pattern

US Distribution to states of: NC, NV, TX, NY, UT, C, MN, NY, WA, NJ, OH, NV, CA and Internationally to: Australia and Japan.

Lot / Code Information

Lot Number: 60084881 Mfg. date: 2017-09-05 Exp. date: 2020-09-05 UDI: (01)05050474534117 (17)200905(10)60084881

Other Recalls from Johnson & Johnson Surgical Vision Inc

Recall # Classification Product Date
Z-1033-2022 Class II TRAY RING COVER, REF OM271000, CONTAINS (1) TRA... Apr 6, 2022
Z-0028-2022 Class II TECNIS Eyhance IOLs are permanent intraocular i... Aug 6, 2021
Z-1163-2021 Class II TECNIS Toric 1-Piece IOL, Model Number: ZCT150 ... Jan 27, 2021
Z-0867-2020 Class II Healon GV PRO 0.85 mL, Model (U.S.): 10-2400-14... Dec 3, 2019
Z-0464-2019 Class II Abbott TECNIS 1-Piece Aspheric Acrylic IOL with... Jun 21, 2018

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.