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'
8065000250 UNITY 27+DS HYPERVIT 30K VIT PROBE
8065753168 UNITY 25+ 7.5K ANTERIOR VIT PROBE
8065753179 UNITY 25+ HYPERVIT 30K VIT 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: 8065000250
UDI-DI code: 00380650002501
Lot/Batch Numbers:
17E6P1
17E77V
Catalog Number: 8065753168
UDI-DI code: 00380657531684
Lot/Batch Number: 17EKTW
Catalog Number: 8065753179
UDI-DI code: 00380657531790
Lot/Batch Number: 17E33N