Recall Z-2109-2025— Alcon Research LLC

Name: FDA recall Z-2109-2025
Creator: U.S. Food and Drug Administration
Published: 2025-04-28

Class II · Ongoing

Class II FDA medical device recall by Alcon Research LLC, initiated 2025-04-28. It names one FDA 510(k) clearance: K141065. 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 Constellation Surgical console. Component: N/A. Reason: 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..

Recalling firm: Alcon Research LLC
Classification: Class II
Status: Ongoing
Initiated: 2025-04-28
Firm location: Fort Worth, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K141065 — CONSTELLATION VISION SYSTEMAlcon Research, Ltd.·cleared 2014-08-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 Constellation Surgical console. Component: N/A

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.