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.
What this means for you
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
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