Johnson & Johnson VISION Reusable LAMINAR High Flow Irrigation Sleeve and Test Chamber 21 Gauge...
FDA Device Recall #Z-1755-2024 — Class II — March 14, 2024
Recall Summary
| Recall Number | Z-1755-2024 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 14, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Johnson & Johnson Surgical Vision, Inc. |
| Location | Irvine, CA |
| Product Type | Devices |
| Quantity | 3,428 units |
Product Description
Johnson & Johnson VISION Reusable LAMINAR High Flow Irrigation Sleeve and Test Chamber 21 Gauge REF OPOHF21L The irrigation sleeve is a device intended to direct irrigation solution across the shaft of a phacoemulsification tip, allowing the solution to enter the eye during ocular surgery.
Reason for Recall
Due to a manufacturing variation of the irrigation sleeves which could result in a missing port hole, this non-conformity could lead to insufficient flow to cool the ultrasonic phaco tip, potentially leading to an unstable anterior chamber which could cause possible harms.
Distribution Pattern
U.S. Nationwide distribution in the states of AZ, CA, CO, FL, GA, IL, LA, MA, MD, ME, MN, MO, NC, NJ, NY, OR, PA, SC, TX, VA, WA, and WI.
Lot / Code Information
Part Number: OPOHF21L UDI-DI/GTIN code: 05050474573376 Lot Numbers: 60477723 60479361 60505085 60508179 60508923
Other Recalls from Johnson & Johnson Surgical Vision, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0735-2024 | Class II | TECNIS Toric II OptiBlue IOL Models ZCW | Dec 12, 2023 |
| Z-2288-2023 | Class II | TECNIS Symfony, Extended Range of Vision IOL, R... | Jul 6, 2023 |
| Z-2289-2023 | Class II | TECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx ... | Jul 6, 2023 |
| Z-2247-2023 | Class II | VERITAS Advanced Infusion Packs (VRT-AI) and VE... | May 30, 2023 |
| Z-1006-2023 | Class II | FUSION Dual Pump Packs, REF: OPO73 | Dec 7, 2022 |
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.