CooperVision Recalls Biofinity XR Toric Contact Lenses Due to Labeling Error
CooperVision is recalling specific Biofinity XR Toric contact lenses because the primary blister labels incorrectly identify them as Biofinity Multifocal Toric.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 classified as FDA Class III, which indicates the product is unlikely to cause adverse health consequences. The issue is a minor labeling error on the primary blister, while the outer carton remains correct.
Plain-English summary
CooperVision Inc. is recalling 120 units of Biofinity XR Toric contact lenses (comfilcon A) due to a labeling error. The affected products are Made-To-Order (MTO) lenses with an expiration date of July 11, 2017. The primary blister labels incorrectly read "Biofinity Multifocal Toric" instead of the correct "Biofinity XR Toric." The outer cartons for these units correctly identify the product as Biofinity XR Toric.
The recall affects specific lots distributed in the USA. Consumers should check their contact lens packaging for the specific lot numbers listed in the recall notice and the expiration date of July 11, 2017. If the primary blister label reads "Biofinity Multifocal Toric" but the outer carton reads "Biofinity XR Toric," the product is affected by this recall.
Consumers with affected products should stop using them and contact CooperVision or their eye care practitioner for instructions on how to return the product or obtain a replacement. This recall is a precautionary measure to ensure patients receive the correct product identification.
The recalled product
- Product
- Biofinity XR Toric contact lenses 8.7/14.5 - 6PK Biofinity XR Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for the correction of ametropia (myopia or hyperopia) with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from…
- Manufacturer
- CooperVision Inc.
- Category
- Medical Device — Contact Lenses
- Hazard
- Affected units
- 120
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 (19)
- Exp. date 2017-07-11
- Lots: R12497769
- R12519016
- R12508969
- R12496191
- R12514162
- R12518889
- R12483347
- R12518980
- R12496182
- R12496192
- R12498168
- R12502974
- R12496166
- R12496196
- R12501147
- R12508370
- R12518890
- R12518978
Distribution
Distribution scope not specified by the agency.
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