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' 8065000252 UNITY 27 GA CHANDELIER 8065000253 UNITY 27+DS
- WIDE ANGLE LIGHT 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 Number8065000252
- UDI-DI code00380650002525
- Lot/Batch Numbers17CMKR 17D417
- Catalog Number8065000253
- UDI-DI code00380650002532
- Lot/Batch Number17CDMX
- Amount recalled
- 330
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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