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U.S. Department of Health and Human Services

Class 2 Device Recall Alcon PRECISION1

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 Class 2 Device Recall Alcon PRECISION1see related information
Date Initiated by FirmSeptember 30, 2025
Date PostedOctober 24, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0326-2026
Recall Event ID 97739
510(K)NumberK182902 
Product Classification Lenses, soft contact, daily wear - Product Code LPL
ProductAlcon PRECISION1 One-Day Contact Lenses, -2.25D.
Code Information GTIN: 00730822254946; Lot Number: A8041128
FEI Number 1610287
Recalling Firm/
Manufacturer		 Alcon Research LLC
6201 South Fwy
Fort Worth TX 76134-2099
For Additional Information ContactKristen Kellerhals
1-817-5514047
Manufacturer Reason
for Recall		Potential for a weak seal in some units resulting in compromise in sterility.
FDA Determined
Cause 2		Process 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 app. You will receive a notification to opt in to this service in your ECP MARLO portal within the next week.
Quantity in Commerce82 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = LPL
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