Contact Lens Axis Mark Misalignment May Cause Blurred Vision
CooperVision's AQUATECH PLUS 1 DAY TORIC contact lenses (lot R0121629) have misaligned axis marks that may cause blurred vision in patients.
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 risk-of-harm medical device defect with no reported injuries. Vision impairment from misaligned axis marks can compromise patient safety and daily functioning, meeting the criterion for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
CooperVision Inc. is recalling one lot of AQUATECH PLUS 1 DAY TORIC daily disposable contact lenses due to misaligned placement of the axis mark. The axis mark on toric lenses indicates the orientation needed for proper astigmatism correction. When misaligned, patients may experience blurred vision.
The affected product is lot number R0121629, consisting of 720 lenses. This defect was identified during the company's quality control processes.
The lenses were distributed worldwide, including in the United States (Florida, New York, Tennessee, Ohio, North Carolina, and Wisconsin) and internationally in France, United Arab Emirates, Brazil, Australia, New Zealand, Taiwan, and Canada.
Patients who have received lenses from this lot should contact their eye care provider to discuss options, which may include replacement lenses or alternative vision correction methods.
The recalled product
- Product
- AQUATECH PLUS 1 DAY TORIC Power: -07.50 -0.75/060 Daily Disposable Contact Lens with UV blocker
- Manufacturer
- CooperVision Inc.
- Category
- Medical Device — Contact Lens
- Hazard
- blurred-vision
- axis-misalignment
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 (1)
- Lot Number: R0121629
Distribution
Distributed nationwide across the United States.
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