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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Johnson & Johnson Surgical Vision, Inc.: Irrigation Sleeve Recalled for Missing Port Hole and Eye Surgery Risks

Agency Publication Date: May 2, 2024
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Summary

Johnson & Johnson Surgical Vision, Inc. has recalled approximately 3,428 units of the Reusable LAMINAR High Flow Irrigation Sleeve and Test Chamber (21 Gauge). This medical device is used during eye surgeries to direct cooling fluid across the phacoemulsification tip and into the eye. A manufacturing defect may result in a missing port hole, which can block the flow of irrigation fluid. This can cause the surgical tip to overheat or lead to an unstable anterior chamber in the eye during surgery. If you are a healthcare provider, please contact the manufacturer for further instructions regarding this voluntary recall.

Risk

A missing port hole in the irrigation sleeve prevents sufficient fluid flow to cool the ultrasonic surgical tip, which can lead to overheating and instability in the eye's anterior chamber, potentially causing surgical complications or injury to the eye.

What You Should Do

  1. Immediately check your inventory for Johnson & Johnson VISION Reusable LAMINAR High Flow Irrigation Sleeve and Test Chamber, 21 Gauge (REF OPOHF21L).
  2. Identify affected units by looking for Lot Numbers 60477723, 60479361, 60505085, 60508179, or 60508923 and UDI-DI/GTIN code 05050474573376.
  3. If you possess any of the affected lot numbers, stop using them immediately and set them aside to prevent use in surgical procedures.
  4. Contact Johnson & Johnson Surgical Vision, Inc. or your healthcare provider to receive specific instructions on returning the product and obtaining a replacement or refund.
  5. For more information or to report any issues, contact the manufacturer at their Irvine, California location or call the FDA at 1-888-463-6332.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer correction/removal

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Johnson & Johnson VISION Reusable LAMINAR High Flow Irrigation Sleeve and Test Chamber 21 Gauge REF OPOHF21L
Model / REF:
OPOHF21L
UPC Codes:
05050474573376
Lot Numbers:
60477723
60479361
60505085
60508179
60508923

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94231
Status: Active
Manufacturer: Johnson & Johnson Surgical Vision, Inc.
Sold By: Authorized medical distributors
Manufactured In: United States
Units Affected: 3,428 units
Distributed To: Arizona, California, Colorado, Florida, Georgia, Illinois, Louisiana, Massachusetts, Maryland, Maine, Minnesota, Missouri, North Carolina, New Jersey, New York, Oregon, Pennsylvania, South Carolina, Texas, Virginia, Washington, Wisconsin

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.