Alcon Research LLC has recalled approximately 28,323 units of its CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K vitrectomy probes and surgical packs. These devices are used by surgeons during ophthalmic procedures to remove vitreous gel from the eye. The recall was initiated due to a potential performance issue that may cause the device to malfunction during surgery. If you are a healthcare provider using these systems, you are advised to stop use and contact Alcon for corrective actions.
A device malfunction during delicate eye surgery can lead to surgical delays or unintentional injury to the eye tissue if the probe fails to perform as expected. No specific injuries have been detailed in this report, but the potential for ocular harm exists if the device performs improperly while inside the eye.
Includes thousands of surgical configuration and pack identifiers (REF/PAK/UDI) distributed worldwide.
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
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