Alcon CONSTELLATION Ultravit 10K & HyperVit 20K Recall for 28,323 Units (2025)

How to identify if yours is affected

1. Review the recall notice for model and UDI numbers.
2. Cross-check your inventory against the provided model list.
3. Identify all affected devices in your facility and quarantine them.

Where to find product info

Refer to the FDA enforcement page linked in the recall notice and Alcon’s official recall communications for identifiers and next steps.

What timeline to expect

Remediation timelines are determined by the manufacturer; facilities should expect coordination with suppliers. Typical recall remediation for medical

If the manufacturer is unresponsive

• Escalate to FDA recall contacts or your hospital supply chain management.
• Document all communications and deadlines with the manufacturer.

How to prevent similar issues

• Implement recall screening for all ophthalmic surgical equipment before procurement.
• Request recall status updates from suppliers prior to accepting shipments.
• Verify UDI and model numbers before reintroducing equipment into operating rooms.

Documentation advice

Keep copies of recall notices, inventory lists, purchase records, and all correspondence with the manufacturer.