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.
Action Details
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.
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,
Code Information / Serial Numbers
Catalog Number: 8065000252
UDI-DI code: 00380650002525
Lot/Batch Numbers:
17CMKR
17D417
Catalog Number: 8065000253
UDI-DI code: 00380650002532
Lot/Batch Number: 17CDMX