Unity Accessory Devices (Alcon) – incomplete seal (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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' 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 sur
Brand
Alcon Research LLC
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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
Alcon Research LLC is recalling Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation sur due to Due to incomplete seals in the pouch which provide the sterile barrier.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to incomplete seals in the pouch which provide the sterile barrier.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026