Alcon Research LLC recalls Brand Name: Alcon Laboratories

Ophthalmic procedure packs may have incomplete seals affecting sterility.

On November 24, 2025, Alcon issued a Urgent Medical Device Notification to affected consignees. Alcon ask affected consignees to take the following actions: 1. Review your inventory to determine if you have any unused affected product within your facility. 2. Segregate and dispose of any unused affected product from your inventory. 3. Call Alcon Customer Service to arrange for replacement of your affected inventory of Alcon Custom Pak. 4. Respond to Alcon indicating your understanding of these instructions. 5. Please forward this notification to all departments within your organization who may be in possession of this affected product; and any other organization to which this product may have been transferred.

• FDA enforcement recordOfficial FDA database entry for Z-0939-2026
• FDA device classification · LROOfficial FDA classification for this device type
• CFR regulation · 21 CFR 878.4370The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Alcon Research LLCSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.