CLASS II ONGOING Device recall · Reported 5 Nov 2025 · FDA Enforcement Report
Alcon PRECISION1 One-Day Contact Lenses, -2.25D recalled
Alcon Research is recalling Alcon PRECISION1 One-Day Contact Lenses, -2.25D, distributed in 19 states. The recall was initiated on 30 Sep 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0326-2026
- FDA event ID
- 97739
- Recalling firm
- Alcon Research, Fort Worth, TX
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 Sep 2025
- FDA classified
- 24 Oct 2025
- Reported
- 5 Nov 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Contact Lenses & Eye Devices
Timeline
| 30 Sep 2025 | Recall initiated by company | |
| 24 Oct 2025 | Classified by FDA | +24 days |
| 5 Nov 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for a weak seal in some units resulting in compromise in sterility.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Alcon PRECISION1 One-Day Contact Lenses, -2.25D.
Where it was distributed
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.
AlabamaArkansasArizonaConnecticutFloridaIowaIdahoLouisianaMassachusettsMarylandMichiganMinnesotaNew JerseyNew YorkOklahomaOregonTennesseeTexasWashington
Questions about this recall
Why was it recalled?
Potential for a weak seal in some units resulting in compromise in sterility.
Which lots are affected?
GTIN: 00730822254946; Lot Number: A8041128
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Alcon Research
All 107| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Systane, Lubricant Eye Gel, Night Gel, Sterile, Processed recalledSystane | Alcon Research | Sterility | Nationwide |
| Drug | CLASS II | GenTeal Tears, Lubricant Eye Gel, Sterile recalled by Alcon ResearchGenteal Tears | Alcon Research | Sterility | Nationwide |
| Device | CLASS I | Alcon Laboratories, Inc Custom Pak recalled by Alcon Research | Alcon Research | Sterility | Nationwide |
| Device | CLASS II | Constellation Ultravit 10K and Constellation Hypervit 20K recalled | Alcon Research | Other | Nationwide |
| Device | CLASS II | Alcon Laboratories, Inc Accessory devices for Unity recalled | Alcon Research | Sterility | Nationwide |
Other Contact Lenses & Eye Devices recalls
All 153| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Pearle Vision 1 day (somofilcon A) Contact Lens recalled by CooperVision | CooperVision | Other | Nationwide |
| Device | CLASS II | Tecnis Eyhance Iol with Tecnis Simplicity" Delivery System recalled | AMO Puerto Rico Manufacturing | Device Malfunction | Nationwide |
| Device | CLASS II | Sofmed Breathables, (stenfilcon A) contact lens recalled by CooperVision | CooperVision | Sterility | Nationwide |
| Device | CLASS II | Voyant 1-Day Premium Toric, (stenfilcon A) contact lens recalled | CooperVision | Sterility | Nationwide |
| Device | CLASS II | MyDay Toric, stenfilcon A) Contact Lens recalled by CooperVision | CooperVision | Sterility | Nationwide |