Alcon Contact Lens Solutions Recalled for Temperature Exposure During Storage and Transit
Multiple Alcon contact lens solutions were recalled due to facility temperature excursions during storage and transit that may have reduced product effectiveness. Affected products include Clear Care and Opti Free Replenish solutions distributed nationwide between June and September 2021.
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 is an FDA Class II recall of medical devices (contact lens solutions) where product effectiveness may be compromised due to temperature exposure during storage and transit. No illnesses, injuries, or deaths have been reported. The hazard is theoretical—effectiveness may be impacted—fitting the rubric criterion for Score 3: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Alcon contact lens solutions, including Clear Care and Opti Free Replenish products in various sizes (2 oz., 4 oz., 10 oz., and 12 oz.), have been recalled. The recalled products were distributed nationwide and include specific model numbers and GTINs associated with lot numbers received between June 1, 2021 and September 30, 2021.
The recall was issued because the products were exposed to elevated temperatures during facility storage between June and August 2021 prior to delivery to distributors. This temperature exposure may have compromised the chemical effectiveness of the lens care solutions.
Consumers who purchased these contact lens solutions during the affected time period should stop using them. Affected consumers should consult their eye care professional to obtain replacement lens solutions and to determine whether their eyes may have been affected by use of potentially compromised solutions.
The recalled product
- Product
- a. Alcon Clear Care Contact Lens Solution Clear Care 12 oz. Solution, Model Number: 65035820, Model Number: USSCupA-12BUP300. b. Alcon Contact Lens Solution Opti Free Replenish 4 oz. Solution Model Number: 00065035604 Model Number: USSCupA-12BUP300. c. Alcon Contact L
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- temperature-excursion
- product-degradation
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)
- a. GTIN: 00047113609126 EA
- 20300650357399 CS All lots received between 7/4/21-9/30/21
Distribution
Distributed nationwide across the United States.
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