ACUVUE ADVANCE Contact Lenses Recalled for Incomplete Sealing
Johnson & Johnson Vision Care is recalling ACUVUE ADVANCE contact lenses because a limited number of packages may not have been completely sealed.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is for a packaging-only problem (incomplete sealing) with no reported injuries or illnesses, which aligns with the 'Low' severity criteria for cosmetic or packaging defects.
Plain-English summary
Johnson & Johnson Vision Care, Inc. is recalling a limited number of ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR. The recall is due to a packaging defect where individual contact lens packages may not have been completely sealed.
The affected product consists of soft, disposable contact lenses indicated for daily wear to correct refractive ametropia. The recall involves 3,546 lenses from specific lot codes: B00DJPQ (-7.00D), B00DMHZ (-6.00D), and B00DMJP (+4.00D).
The product was distributed worldwide, including nationwide in the United States and in numerous international countries. Consumers should check their packages for the listed lot codes and ensure they are completely sealed. If a package is not sealed, consumers should stop using the lenses and contact the manufacturer for instructions.
The recalled product
- Product
- ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR, Soft, disposable contact lenses. The Vistakon (galyfilcon A) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or non-aphakic persons with non-diseased…
- Manufacturer
- Johnson & Johnson Vision Care, Inc.
- Category
- Medical Device — Contact Lenses
- Hazard
- Affected units
- 3,546
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 (4)
- Lot Codes: B00DJPQ
- -7.00D B00DMHZ
- -6.00D B00DMJP
- +4.00D
Distribution
Part of a larger recall action
This product is one of 2 recalled by Johnson & Johnson Vision Care, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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