Contact lenses for astigmatism recalled due to incorrect cylinder power
CooperVision is recalling multiple brands of daily disposable toric contact lenses manufactured with incorrect cylinder power in certain lot codes. Users of affected lenses should stop wearing them and contact their eye care provider.
What this means for you
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: This is a Class II FDA medical device recall with a manufacturing defect affecting optical correctness. No illnesses or injuries have been reported. According to the severity rubric, this qualifies as a 'risk-of-harm product where injury has not yet been reported,' corresponding to a High severity score.
Plain-English summary
CooperVision, Inc. is recalling daily disposable toric contact lenses manufactured under multiple brand names, including MyDay Toric, LensCrafters One Day Premium Daily Disposable Contact Lenses For Astigmatism, Pearle Vision 1 Day Premium For Astigmatism, Voyant 1-Day Premium Toric, and others. These silicone hydrogel lenses are designed to correct astigmatism.
A limited number of manufacturing lots were produced with an incorrect cylinder power. The cylinder power is the optical correction for astigmatism; an incorrect value means the lenses will not provide the intended vision correction for wearers of affected lots.
The recall affects 33,990 contact lenses—17,010 distributed in the United States and 16,980 internationally. U.S. distribution included California, Colorado, Florida, Illinois, Kentucky, Michigan, North Carolina, Nebraska, New Jersey, New York, Ohio, Oregon, Utah, Virginia, and Washington. Specific affected lot numbers are available from the FDA or the manufacturer.
If you have contact lenses from the affected lots, discontinue use and contact your eye care provider or the retailer where you obtained them for replacement or an alternative product.
The recalled product
- Product
- Brand Names: MyDay Toric, LensCrafters One Day Premium Daily Disposable Contact Lenses For Astigmatism, Pearle Vision 1 Day Premium For Astigmatism, REVEAL 1-DAY TORIC, Vision Source Reveal Toric, Voyant 1-Day Premium Toric. Brand Names (OUS only): CADENCE DELUXE 1-DAY TORIC, DUB
- Manufacturer
- CooperVision, Inc.
- Hazard
- incorrect-optical-power
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 (14)
- Blister Lot Numbers: (1) 6461501582
- (2) 6461501590
- (3) 6448502235
- (4) 6472500679. Carton Lot numbers: (1) 19346502595028
- (2a) 344446500117
- (2b) 19346502613
- (2c) 21455502575
- (3a) 21476504025
- (3b) 21545502813
- (3c) 24127502235
- (3d) 40702500019
- (4a) 21512501331
- (4b) 21492501653
- (4c) 21492501685
Distribution
Distributed in 15 states:
- CA
- CO
- FL
- IL
- KY
- MI
- NC
- NE
- NJ
- NY
- OH
- OR
- UT
- VA
- WA
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