Daily contact lenses recalled over a weak seal compromising sterility
Alcon Research is recalling 82 units of PRECISION1 One-Day Contact Lenses in -2.25D because some units may have a weak seal that compromises sterility.
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: Scored 3 under the risk-of-harm criterion: a compromised sterile barrier on a lens placed on the eye creates an infection risk, and no injuries are reported.
Plain-English summary
Alcon PRECISION1 One-Day Contact Lenses in the -2.25D power are being recalled.
There is potential for a weak seal in some units, resulting in a compromise in sterility.
The recall covers 82 units carrying GTIN 00730822254946, from lot A8041128. Distribution was worldwide, including United States distribution in Alabama, Arizona, Arkansas, Connecticut, Florida, Idaho, Iowa and other states. The FDA has classified the action as Class II.
A compromised seal can allow a lens to lose sterility before it reaches the eye. Wearers and eye care practitioners holding lot A8041128 should stop using it and follow Alcon's instructions.
The recalled product
- Product
- Alcon PRECISION1 One-Day Contact Lenses, -2.25D.
- Manufacturer
- Alcon Research LLC
- Category
- Medical Device — Contact lens
- Affected units
- 82
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)
- GTIN: 00730822254946
- Lot Number: A8041128
Distribution
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