Z-0326-2026Class II

Alcon PRECISION1 One-Day Contact Lenses, -2.25D

Name: Z-0326-2026 Alcon PRECISION1 One-Day Contact Lenses, -2.25D
Creator: Alcon Research LLC
Published: 2025-09-30
License: https://open.fda.gov/license/

Alcon Laboratories / initiated 2025-09-30 / Open, Classified / root cause: manufacturing process

FDA source

Alcon Research LLC began a recall of Alcon PRECISION1 One-Day Contact Lenses, -2.25D on 2025-09-30. FDA classified it as Class II and gives the reason as "Potential for a weak seal in some units resulting in compromise in sterility". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0326-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-09-30
Posted: 2025-10-24
Recalling firm: Alcon Laboratories
Product: Alcon PRECISION1 One-Day Contact Lenses, -2.25D.
Product code: LPL Lenses, Soft Contact, Daily Wear
Reason for recall: Potential for a weak seal in some units resulting in compromise in sterility.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Alcon notified consignees via letter on about 09/30/2025. Consignees were instructed to cease distribution of affected units to patients, review inventory to determine if affected units are on hand, dispose of all affected units, complete and return the response form, and forward the notification to other facilities or departments if product has been further distributed or transferred. For MARLO direct-to-patient shipments: As a part of our MARLO service, Alcon can notify patients who have received shipments directly from Alcon and initiate replacement on your behalf via the MARLO portal and app. You will receive a notification to opt in to this service in your ECP MARLO portal within the next week.
Quantity in commerce: 82 units
Distribution: Worldwide - US distribution in the states of Alabama, Arizona, Arkansas, Connecticut, Florida, Idaho, Iowa, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, New Jersey, New York, Oklahoma, Oregon, Tennessee, Texas, Washington and the country of Canada.
Product codes and lots: GTIN: 00730822254946; Lot Number: A8041128

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0326-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0326-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-05	2025-10-24

Product code LPL

K182902Class IIPrecision1Alcon Laboratories, Inc. / cleared 2018-12-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)