CooperVision Recalls Pro Clear 1 Day Sphere Contact Lenses for Incorrect Expiry Dates
CooperVision is recalling 153 cartons of Pro Clear 1 Day Sphere contact lenses because the outer cartons display incorrect expiration dates, although the inner blisters are correct.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II recall involving a labeling error (incorrect expiration date on the secondary package) where the primary package is correct, fitting the criteria for minor labeling errors or low-risk issues.
Plain-English summary
CooperVision Inc. is recalling 153 cartons of Pro Clear(R) 1 day Sphere (o mafilcon A) daily disposable contact lenses. The recall involves specific lots where the secondary package (carton) was labeled with incorrect expiration dates. The primary package (blister) is marked with the correct expiration date.
The affected product was distributed worldwide, including the United States (nationwide), Aruba, Canada, Colombia, and Trinidad. The recall is limited to the specific lot numbers listed in the agency's structured data, which range from 361950571720 to 361951057108.
Consumers should check the expiration date on the primary package (blister) rather than the secondary package (carton). If the product is from one of the affected lots, consumers should stop using it and contact the manufacturer for instructions.
The recalled product
- Product
- Pro clear(R) 1 day Sphere (o mafilcon A), 90 daily disposable contact lenses, STERILE, Rx ONLY --- Coopervision Shamble, SO 31 4 RF, UK - Scottsville, NY 14546 USA - Juana Diaz, PR 00795 USA daily use disposable contact lenses
- Manufacturer
- CooperVision Inc.
- Category
- Medical Device — Contact Lenses
- Hazard
- Affected units
- 153
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 (20)
- Lot 361950571720
- potential incorrect expiry date 1/2018
- Lot 361950575934
- potential incorrect expiry date 9/2017
- Lot 361950589008
- potential incorrect expiry date 2/2018
- Lot 361950590915
- potential incorrect expiry date 8/2018
- Lot 361950597210
- potential incorrect expiry date 7/2017
- Lot 361950599011
- Lot 361950599816
- Lot 361950606714
- potential incorrect expiry date 12/2017
- Lot 361950608721
- potential incorrect expiry date 6/2018
- Lot 361950613813
- Lot 361950632507
- potential incorrect expiry date 3/2018
- Lot 361950638202
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by CooperVision 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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