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.
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.
Manufacturer correction/removal
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.
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.