Reported Nov 5, 2025 · Ongoing
Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles…
Alcon Research LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Alcon Research LLC · 6201 South Fwy · Fort Worth, TX · 76134-2099
Is this the product you have?
- Brand NameAlcon Laboratories, Inc
- Product NameAccessory devices for Unity and Constellation
- surgical consoles Model/Catalog NumberMany - 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 VersionN/A
- Product DescriptionThese products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console
- ComponentN/A
- Lot codes and dates
- Catalog Number8065000250
- UDI-DI code00380650002501
- Lot/Batch Numbers17E6P1 17E77V
- Catalog Number8065753168
- UDI-DI code00380657531684
- Lot/Batch Number17EKTW
- Catalog Number8065753179
- UDI-DI code00380657531790
- Lot/Batch Number17E33N
- Amount recalled
- 577
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
Due to incomplete seals in the pouch which provide the sterile barrier.
This product could cause temporary or reversible health problems — stop using it.
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