FDA Medical Device Recalls (openFDA)
Alcon Research LLC: Alcon PRECISION1 One-Day Contact Lenses, -2.25D.
- Recall number
- Z-0326-2026
- Recalling firm
- Alcon Research LLC
- Product
- Alcon PRECISION1 One-Day Contact Lenses, -2.25D.
- Status
- Open, Classified
- Initiated
- 2025-09-30
- Posted
- 2025-10-24
- Terminated
- not on file
- Reason
- Potential for a weak seal in some units resulting in compromise in sterility.
- Root cause
- Process control
- 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.
- 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.
- Lot, serial or model codes
- GTIN: 00730822254946; Lot Number: A8041128
- 510(k) numbers
- ["K182902"]
- PMA numbers
- not on file
- Product code
- LPL
- Firm FEI
- 1610287
- Firm city
- Fort Worth
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28