Alcon PRECISION1 One-Day Contact Lenses, -2.25D.
FDA Recall Z-0326-2026 · Posted 2025-10-24
Advertisement
Recalling FirmAlcon Research LLC
Recall StatusOpen, Classified
Product CodeLPL
Date Initiated2025-09-30
Product Quantity82 units
Reason for Recall
Potential for a weak seal in some units resulting in compromise in sterility.
Firm 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.
Root Cause
Process control
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement