Recall Z-0307-2026— Alcon Research LLC
Class II · Ongoing
Class II FDA medical device recall by Alcon Research LLC, initiated 2025-08-05. FDA's recall record names no specific 510(k) clearance for this event. Product: Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000252 UNITY 27 GA CHANDELIER 8065000253 UNITY 27+DS WIDE ANGLE LIGHT PROBE Software Version: N/A Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console. Component: N/A. Reason: Due to incomplete seals in the pouch which provide the sterile barrier..
- Recalling firm
- Alcon Research LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-08-05
- Firm location
- Fort Worth, TX, United States
Product description
Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000252 UNITY 27 GA CHANDELIER 8065000253 UNITY 27+DS WIDE ANGLE LIGHT PROBE Software Version: N/A Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console. Component: N/A
Reason for recall
Due to incomplete seals in the pouch which provide the sterile barrier.
Data sourced from openFDA. This site is unofficial and independent of the FDA.