Recall Z-0326-2026— Alcon Research LLC

Name: FDA recall Z-0326-2026
Creator: U.S. Food and Drug Administration
Published: 2025-09-30

Class II · Ongoing

Class II FDA medical device recall by Alcon Research LLC, initiated 2025-09-30. It names one FDA 510(k) clearance: K182902. Product: Alcon PRECISION1 One-Day Contact Lenses, -2.25D.. Reason: Potential for a weak seal in some units resulting in compromise in sterility..

Recalling firm: Alcon Research LLC
Classification: Class II
Status: Ongoing
Initiated: 2025-09-30
Firm location: Fort Worth, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K182902 — Precision1Alcon Laboratories, Inc.·cleared 2018-12-11

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

Alcon PRECISION1 One-Day Contact Lenses, -2.25D.

Reason for recall

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

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