The Recall Desk
ModerateFDA (Devices)·Z-0543-2014·Announced 2013-12-25

CooperVision Recalls ClearSight Toric Contact Lenses for Incorrect Expiration Dates

CooperVision is recalling specific lots of ClearSight Toric 1 day contact lenses because the outer cartons display incorrect expiration dates, though the inner blisters are correct.

What this means for you

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 an FDA Class II recall involving a labeling error (incorrect expiration date on secondary packaging) where the primary packaging is correct, fitting the criteria for minor labeling errors or low-risk issues.

Plain-English summary

CooperVision Inc. is recalling 45 cartons of ClearSight(TM) Toric 1 day (ocufilcon D) daily disposable contact lenses for astigmatism. The recall involves specific lots where the secondary package (carton) is labeled with an incorrect expiration date. The primary package (blister) for these units is marked with the correct expiration date.

The affected lots were distributed worldwide, including the United States (nationwide), Aruba, Canada, Colombia, and Trinidad. The specific lot numbers and their associated potential incorrect expiration dates are listed in the recall documentation.

Consumers should check their contact lens cartons against the list of affected lot numbers. If a carton matches one of the listed lots, consumers should stop using the product and contact CooperVision for instructions on return or replacement. The primary blister packaging contains the correct expiration date, which can be used for verification.

The recalled product

Product
ClearSight(TM) Toric 1 day (ocufilcon D), 30 daily disposable contact lenses for astigmatism, STERILE, Rx only --- CooperVision Hamble, SO31 4RF, UK - Scottsville, NY 14546 USA - Juana Diaz, PR 00795 USA daily use disposable contact lenses for astigmatism
Manufacturer
CooperVision Inc.
Affected units
45

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 446350083516
  • potential incorrect expiry date 6/2019
  • Lot 446450110928
  • potential incorrect expiry date 2/2019
  • Lot 446450173709
  • potential incorrect expiry date 4/2018
  • Lot 446450191100
  • potential incorrect expiry date 5/2019
  • Lot 446550083005
  • Lot 446550084607
  • potential incorrect expiry date 2/2018
  • Lot 446650162408
  • Lot 446650177200
  • Lot 446650178110
  • potential incorrect expiry date 6/2017
  • Lot 446650179207
  • potential incorrect expiry date 6/2018
  • Lot 446750082713
  • potential incorrect expiry date 7/2019
  • Lot 446850029326

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.

See all 2 products in this recall →