The Recall Desk
Severity pendingFDA (Devices)·Z-2109-2025·Announced 2025-07-16

Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Combined Procedure P

Pending LLM rewrite. Source: FDA_DEVICE Z-2109-2025.

Severity not yet assessed

We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.

Plain-English summary

Due to the potential that some units within specific lots were damaged during the manufacturing process. The area of damage is within the same area of the lidding. While the damage in the lidding is visibly noticeable, due to risk of sterility being compromised.

The recalled product

Product
Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Combined Procedure Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Surgical procedure pack to interface with Alcon Constellati
Manufacturer
Alcon Research LLC

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (7)

  • 23G
  • 5.0 CPM
  • 0.9STD
  • 0.9
  • V
  • 0.9MM
  • W/O PROBE

Distribution

Distributed nationwide across the United States.