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.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new packaged foods recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:38 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.