Alcon Research, LLC is recalling 57,352 Alcon Custom Paks surgical procedure packs because they contain Oasis 27Ga Chang Hydrodissection Cannulas that may have particulates, residue, blockages, or bent tips. These surgical packs are used by surgeons during various eye operations, including cataract surgeries. The defect was identified following complaints regarding the sterile cannulas included within these pre-assembled surgical collections. Consumers and healthcare facilities should identify affected packs by the Pak REF and lot numbers distributed worldwide between 2023 and 2024.
The presence of particulates, residue, or a bent tip on a surgical cannula can lead to serious complications during eye surgery, including infection, inflammation, or physical trauma to delicate ocular tissues. Blockages (occlusions) in the cannula can also cause surgical delays or equipment failure during critical procedures.
Contact healthcare provider or manufacturer for instructions.
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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 · FDA Press Release · 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.