Alcon PRECISION1 One-Day Contact Lenses, -2.25D.
FDA device recall Z-0326-2026 · posted 2025-10-24 · Open, Classified
Recall details
- Recalling firm
- Alcon Research LLC
- Reason for recall
- Potential for a weak seal in some units resulting in compromise in sterility.
- Action taken
- 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
- Status
- Open, Classified
- Product code
- LPL
- Quantity affected
- 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, Ore
- Date initiated
- 2025-09-30
- Date posted
- 2025-10-24
- Location
- Fort Worth, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Precision1 (K182902) | Alcon Laboratories, Inc. | 2018-12-11 |