Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2108-2025 — Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Vitrectomy 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 Constellation Surgical consol

U.S. FDA — Device Enforcement · United States · 2025-04-28 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2108-2025
Date of alert: 2025-04-28
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Alcon Research LLC
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 8065000093

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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