Z-0326-2026 Class II Ongoing

Recalled by Alcon Research LLC — Fort Worth, TX

FDA device recall Z-0326-2026 was initiated by Alcon Research LLC on September 30, 2025 and is designated Class II. Reason for recall: Potential for a weak seal in some units resulting in compromise in sterility. The recall status is ongoing. Affected quantity: 82 units.

Recall Details

Product Type
Devices
Report Date
November 5, 2025
Initiation Date
September 30, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
82 units

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.

Distribution Pattern

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.

Code Information

GTIN: 00730822254946; Lot Number: A8041128