Alcon Research LLC: Device Recall

Recall #Z-0490-2025 · 10/15/2024

Class III: Low Risk

Recall Details

Recall Number: Z-0490-2025
Classification: Class III
Product Type: Device
Recalling Firm: Alcon Research LLC
Status: Ongoing
Date Initiated: 10/15/2024
Location: Fort Worth, TX, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 3486 surgical kits

Reason for Recall

Reported breakage in the tubing Anti-Reflux Valve (ARV) due to improper use. As a result, changes to labeling were made.

Product Description

a) Alcon Custom-Pak CONSTELLATION 25G PLUS CHRISTIANA CARE HLTH SERV, # 15340-11, containing TUBING, SALEM SUMP, 14 FR; b) Alcon Custom-Pak DR GREEN VITRECTOMY MERCY HOSPITAL, # 6557-59 and # 6557-60 each containing TUBING, SALEM SUMP, 18 FR; c) VITRECTOMY ILLINOIS MASONIC MED CTR, # 9456-59, # 9456-60, and # 9456-61 each containing TUBING, SALEM SUMP, 18 FR; d) VITRECTOMY MCGEE EYE SURG CTR, # 12216-12, # 12216-14, and # 12216-15, each containing TUBING, SALEM SUMP, 14 FR.

Distribution Pattern

US distribution to states of: Delaware, Illinois, and Oklahoma

Other Recalls by Alcon Research LLC

Class I: Dangerous 11/24/2025

Ophthalmic procedure packs may have incomplete seals affecting sterility.
Class II: Risk 09/30/2025

Potential for a weak seal in some units resulting in compromise in sterility.
Class II: Risk 09/15/2025

XXX
Class II: Risk 08/05/2025

Due to incomplete seals in the pouch which provide the sterile barrier.
Class II: Risk 08/05/2025

Due to incomplete seals in the pouch which provide the sterile barrier.

View all recalls by Alcon Research LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.