Alcon Research LLC recalls Alcon PRECISION1 One-Day Contact Lenses
Reason for recall
Potential for a weak seal in some units resulting in compromise in sterility.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Alcon PRECISION1 One-Day Contact Lenses, -2.25D.
Lot / code information
- GTIN
- 00730822254946
- Lot #
- A8041128
What the firm is doing
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.
DistributionShow detailsHide
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.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-0326-2026
- FDA 510(k) clearance · K182902The device's official FDA premarket clearance record
- FDA device classification · LPLOfficial FDA classification for this device type
- CFR regulation · 21 CFR 886.5925The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Alcon Research LLCSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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