Alcon Research LLC recalls Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Mode…

Recall date

August 5, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0307-2026

FDA classification

Class II

Brand / firm

Alcon Research LLC

Sold / distributed

Worldwide distribution: US (nationwide): AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC,SD,TN, TX, VA, WA, WI, and WV; and OUS (foreign) to countries of: Argentina, Australia, Austria, Azerba…

Why it was recalled

Due to incomplete seals in the pouch which provide the sterile barrier.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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