Alcon Recalls TEARS Naturale FREE Eye Drops Due to Sterility Concerns
Alcon is recalling TEARS Naturale FREE eye drops because some vials may contain water instead of the product, creating a sterility risk.
The agency’s classification
FDA (Drugs): 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, FDA Class II recalls with potential for significant injury or hospitalization (implied by sterility failure in an ophthalmic product) map to a score of 4 (Severe).
Plain-English summary
Alcon Research, Ltd. is recalling 12,648 cartons of TEARS Naturale FREE lubricant eye drops. The affected product consists of 0.9 mL single-use vials packaged in 60-count cartons. The specific lot number is KRJ006, with an expiration date of 09/17. The product was distributed nationwide.
The recall was initiated because some single-use vials may have been filled with water rather than the intended product solution. The firm cannot guarantee the sterility of these water-filled vials, which presents a lack of assurance of sterility for the product.
Consumers who have purchased this specific lot of TEARS Naturale FREE eye drops should stop using the product and contact Alcon Research, Ltd. for further instructions or a refund.
The recalled product
- Product
- TEARS Naturale FREE (dextran 70 and hypromellose 2910) lubricant eye drops, 1% and 0.3%, Preservative Free, 0.9 mL (0.03 FL OZ) Single-Use Vials, packaged in 60-count Single-Use Vials per carton, Manufactured for: Alcon Laboratories, Inc., Fort Work, TX 76134, Barcode…
- Manufacturer
- Alcon Research, Ltd.
- Category
- Drug — Ophthalmic
- Affected units
- 12,648
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 (2)
- Lot #: KRJ006
- Exp 09/17
Distribution
Distributed nationwide across the United States.
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