Alcon Research LLC Recalls

All product recalls associated with Alcon Research LLC.

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Recall Summary

Total Recalls

36

Past Year

6

Class I (Serious)

1

Most Recent

Nov 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–20 of 36 recalls

Brand Name: Alcon Laboratories, Inc. Product Name: Custom... (Alcon Research LLC) – ophthalmic procedure packs may have i... (2025)

Ophthalmic procedure packs may have incomplete seals affecting sterility.

Moderate

FDANov 24, 2025Nationwide• Alcon Research LLC

PRECISION1 Contact Lenses (Alcon) – sterility seal (2025)

Potential for a weak seal in some units resulting in compromise in sterility.

Moderate

FDASep 30, 2025AL, AZ, AR +17 more• Alcon Research LLC

CONSTELLATION Ultrasound (Alcon) – Unspecified Issue (2025)

XXX

Moderate

FDASep 15, 2025Nationwide• Alcon Research LLC

Unity Accessory Devices (Alcon) – incomplete seal (2025)

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

Moderate

FDAAug 5, 2025Nationwide• Alcon Research LLC

Constellation Vision System (Alcon) – Manufacturing Damage (2025)

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.

Moderate

FDAApr 28, 2025Nationwide• Alcon Research LLC

Alcon Custom Pak (Alcon) – latex component labeling (2025)

Customer-designed sterile surgical procedure packs contain latex components as specified; but, the content label sealed within the transparent sterile pouch contains the symbol for a latex-free product. If users or patients with latex sensitivity come into contact with latex, an allergic reaction may occur.

Moderate

FDAFeb 10, 2025Nationwide• Alcon Research LLC

Systane Eye Drops (Alcon) – non-sterility concern (2024)

Non-Sterility

Class IHigh

FDADec 18, 2024Nationwide• Alcon Research LLC

Alcon Research LLC: Brand Name: Alcon Product Name: Monarch III D Delivery Ca...

Increase in complaints associated with a molding defect within the inner lumen of delivery cartridges which could result in a scratch on the intraocular lens (IOL) upon delivery.

Moderate

FDANov 13, 2024AL, AK, AZ +47 more• Alcon Research LLC

Alcon Research LLC: a) Alcon Custom-Pak CONSTELLATION 25G PLUS CHRISTIANA CAR...

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

Moderate

FDAOct 15, 2024DE, IL, OK• Alcon Research LLC

Alcon Research LLC: DAILIES TOTAL1, DAILIES TOTAL1 for Astigmatism, DAILIES T...

Material with a quality issue was used in contact lens production, so contact lenses may not meet quality and/or performance standards for the entirety of their labeled shelf life, and wearing these lenses may lead to temporary issues such as irritation, redness, or blurred vision.

Moderate

FDAAug 8, 2024AL, AK, AZ +48 more• Alcon Research LLC