Alcon Research LLC: Device Recall
Recall #Z-0307-2026 · 08/05/2025
Recall Details
- Recall Number
- Z-0307-2026
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Alcon Research LLC
- Status
- Ongoing
- Date Initiated
- 08/05/2025
- Location
- Fort Worth, TX, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 330
Reason for Recall
Due to incomplete seals in the pouch which provide the sterile barrier.
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
Distribution Pattern
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, Azerbaijan, Bahrain, Bangladesh, Belgium, Brazil, Brunei, Canada, Chile, China, Colombia, Croatia, Czechia, Denmark, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Korea, Kosovo, Luxembourg, Malaysia, Mexico, Moldova, Montenegro, Morocco, Netherlands, New Zealand, Pakistan, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and United Kingdom,
Other Recalls by Alcon Research LLC
- Class I: Dangerous 11/24/2025
- Class II: Risk 09/30/2025
- Class II: Risk 09/15/2025
- Class II: Risk 08/05/2025
- Class II: Risk 08/05/2025