Class 2 Device Recall Alcon Laboratories, Inc.

• Date Initiated by Firm: August 05, 2025
• Date Posted: October 24, 2025
• Recall Status: Open, Classified
• Recall Number: Z-0307-2026
• Recall Event ID: 97415
• Product Classification: Endoilluminator - Product Code MPA
• 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
• Code Information: Catalog Number: 8065000252 UDI-DI code: 00380650002525 Lot/Batch Numbers: 17CMKR 17D417 Catalog Number: 8065000253 UDI-DI code: 00380650002532 Lot/Batch Number: 17CDMX
• FEI Number: 1610287
• Recalling Firm/ Manufacturer: Alcon Research LLC; 6201 South Fwy; Fort Worth TX 76134-2099
• For Additional Information Contact: Kristen Kellerhals; 1-817-5514047
• Manufacturer Reason for Recall: Due to incomplete seals in the pouch which provide the sterile barrier.
• FDA Determined Cause: Process control
• Action: On 08/05/2025, the firm sent via FedEx Overnight an "URGENT: MEDICAL DEVICE RECALL" Letter to customers informing them that for the Alcon Standalone Vitrectomy Consumables, there is potential for some pouches within impacted lots to have an incomplete seal. Customers are instructed to: locate and dispose of any affected lots of Alcon Standalone Vitrectomy Consumables remaining in your inventory. To comply with this Medical Device Recall and request the replacement of any unused product, please take the following steps: 1. Review inventory to determine if there are any unused affected product within their facility. See table on page 1 for affected Standalone Vitrectomy Consumable lots shipped to your location. 2. Segregate and dispose of any unused affected product from their inventory. 3. Call Alcon Customer Service to arrange for replacement of the affected inventory of Alcon Standalone Vitrectomy Consumables. 4. Respond to Alcon indicating understanding of these instructions even if they have zero (0) units remaining in inventory by completing the online response form at https://qrco.de/Vit-Seal or by completing and returning the attached Response Form and returning to Alcon via email: Market.Actions@Alcon.com or fax: 817-302-4337. 5. Forward this notification to all departments within their organization who may be in possession of this affected product; and any other organization to which this product may have been transferred. For questions contact, Alcon Customer Service at 1-800-862-5266 or an Alcon Sales Representative.
• Quantity in Commerce: 330
• Distribution: 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,
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.