Alcon contact lenses recalled for manufacturing quality defect
Alcon is recalling approximately 92,835 packs of contact lenses because a material quality issue may affect lens performance standards. Wearers may experience temporary eye irritation, redness, or blurred vision.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves contact lenses with a manufacturing defect that may not meet quality and performance standards. Although no injuries have been reported, the product poses a risk of temporary eye irritation, redness, and blurred vision. Per the rubric, risk-of-harm products where injury has not yet been reported warrant a score of 3.
Plain-English summary
Alcon Research LLC is recalling approximately 92,835 packs of contact lenses due to a manufacturing quality issue. Material used in production may not meet the quality and performance standards for the lenses' entire labeled shelf life.
The recall affects four contact lens products: DAILIES TOTAL1, DAILIES TOTAL1 for Astigmatism, DAILIES TOTAL1 Multifocal, and TOTAL30 Sphere. Specific lot numbers and expiration dates are listed in the FDA recall notice. The affected lenses were distributed throughout the United States and internationally.
Consumers who own lenses from the recalled lot numbers should discontinue use and consult their eye care provider for replacement lenses. Wearing the defective lenses may result in temporary eye irritation, redness, or blurred vision.
The recalled product
- Product
- DAILIES TOTAL1, DAILIES TOTAL1 for Astigmatism, DAILIES TOTAL1 Multifocal, TOTAL30 Sphere,
- Manufacturer
- Alcon Research LLC
- Category
- Medical Device — Contact Lenses
- Affected units
- 92,835
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Product/UDI-DI(GTIN)/Expiration: Lots: DAILIES TOTAL1/00630175507808
- 00630175507754
- 00630175507181
- 00630175507662
- 00630175508423
- 00630175507679
- 00630175507778
- 00630175507075
- 00630175507730
- 00630175507839
- 00630175508362
- 00630175508348
- 00630175508393
- 00630175508263
- 00630175508324
- 00630175507242
- 00630175508256
- 00630175507815
- 00630175507266
- 00630175508287
Distribution
Related recalls
Same manufacturer · Alcon Research LLC
See all →- SevereGenTeal Tears Lubricant Eye Gel Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-05-06
- SevereSystane Lubricant Eye Gel Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-05-06
- CriticalOphthalmic surgical packs recalled over incomplete seals affecting sterility
FDA (Devices) · 2025-12-31
- ModerateVitrectomy probe packs recalled with no reason stated in the record
FDA (Devices) · 2025-12-03
- HighInfusion line packs recalled over incomplete seals in sterile pouches
FDA (Devices) · 2025-11-05
Same hazard · eye irritation
See all →- LowSyva Emit Disopyramide Enzyme Immunoassay Calibrator Recalled for Sodium Azide Concentration
FDA (Devices) · 2026-08-12
- High
- HighmGanna Sodium Hydroxide Pellet Bags Recalled Over Chemical Burn Risk
CPSC · 2026-04-23
- High
- SevereGE Healthcare Infant Incubator Recall: Airborne Formaldehyde Off-Gassing
FDA (Devices) · 2024-11-06
Similar recalls
- HighDaily contact lenses recalled over a weak seal compromising sterility
FDA (Devices) · 2025-11-05
- HighAlden Classic 55 Toric Contact Lenses Recalled for Sterility Issues
FDA (Devices) · 2018-03-21
- SevereAlden Optical Recalls Contact Lenses Lacking Sterility Assurance
FDA (Devices) · 2018-03-21
- HighAlcon Contact Lens Solutions Recalled for Temperature Exposure During Storage and Transit
FDA (Devices) · 2022-08-31
- SevereAlden HP59 Toric Contact Lenses Recalled for Lack of Sterility Assurance
FDA (Devices) · 2018-03-21
- HighAlden Optical Recalls NovaKone Toric Contact Lenses for Sterility Issues
FDA (Devices) · 2018-03-21