Summary
The FDA issued a Class II for Alcon PRECISION1 One-Day Contact Lenses, -2.25D. by Alcon Research LLC. Reason: Potential for a weak seal in some units resulting in compromise in sterility..
Details
Source
Device Recall
External ID
Z-0326-2026
Action Date
2025-11-05
Status
Ongoing
Category
device
Product Description
Alcon PRECISION1 One-Day Contact Lenses, -2.25D.
Lot/Code Info: GTIN: 00730822254946; Lot Number: A8041128
Quantity Affected: 82 units
Reason for Recall
Potential for a weak seal in some units resulting in compromise in sterility.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-09-30
Company
Fort Worth, TX
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 284 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Alcon Research LLC has 66 FDA actions in our database, including 66 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Alcon Research LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Alcon Research LLC have FDA actions?
Alcon Research LLC has 66 FDA actions in our database, including 66 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0326-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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