Alcon Research LLC has recalled 151 Alcon Custom Pak ophthalmic procedure packs. These customer-designed kits contain various surgical instruments and materials intended for use by surgeons during eye surgeries. The recall was initiated because the packs may have incomplete seals, which could compromise the sterility of the surgical instruments contained inside.
If surgical instruments are used from a pack with an incomplete seal, there is a risk of infection or other surgical complications due to potential contamination. No injuries have been reported to date.
Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons.
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 · 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.