ClearanceBrief
Recall Z-0326-2026 ยท LPL Lenses, Soft Contact, Daily Wear

Alcon Research LLC

Alcon PRECISION1 One-Day Contact Lenses, -2.25D.

DateOct 24, 2025 (initiated Sep 30, 2025)
StatusOpen, Classified
ReasonPotential for a weak seal in some units resulting in compromise in sterility.
Root causeProcess control
ActionAlcon 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
Quantity82 units
DistributionWorldwide - 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.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K182902Precision1
Alcon Laboratories, Inc., Dec 11, 2018