Alcon Research LLC recalled 28,323 CONSTELLATION ULTRAVIT and HYPERVIT devices on September 15, 2025, due to a high hazard risk. The recall affects products distributed worldwide, including multiple states in the U.S. and several countries.
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Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Alcon Research LLC or your healthcare provider for instructions. Notification method: Letter
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The recall includes models such as CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K, among others. These devices were sold worldwide, including states like CA, FL, and NY. Specific model numbers include 8065000093, 8065000095, and others.
The devices pose a high risk to patients and healthcare providers, with potential electrical hazards. The recall was classified as Class II due to the severity of possible health impacts.
No specific incidents have been reported, but the risk level is classified as high, suggesting potential for serious injury.
Patients and healthcare providers should stop using these devices immediately. Contact Alcon Research LLC or your healthcare provider for further instructions.
For more information, call Alcon Research LLC at 1-800-XXX-XXXX or visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0581-2026.
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