Recall Z-0326-2026
Alcon Research LLC · initiated September 30, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Alcon PRECISION1 One-Day Contact Lenses, -2.25D.
Codes / lots: GTIN: 00730822254946; Lot Number: A8041128
Reason for recall
Potential for a weak seal in some units resulting in compromise in sterility.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-0326-2026
- Initiated
- September 30, 2025
- Posted by FDA
- October 24, 2025
- Product code
- LPL – Lenses, Soft Contact, Daily Wear
- Quantity
- 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.
- Recalling firm
- Alcon Research LLC, Fort Worth, TX