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.
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 3/5 (High).
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
- Affected units
- 720
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
Part of a larger recall action
This product is one of 12 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 12 products in this recall →Related recalls
Same manufacturer · CooperVision Inc.
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Same hazard · blurred vision
See all →- HighAlcon contact lenses recalled for manufacturing quality defect
FDA (Devices) · 2024-10-09
- ModerateContact Lens Axis Mark Misalignment Causes Blurred Vision
FDA (Devices) · 2021-08-04
- HighContact lens recall: misaligned axis mark may cause blurred vision
FDA (Devices) · 2021-08-04
- HighCooperVision CLARITI 1 DAY TORIC contact lenses recalled for axis mark misalignment
FDA (Devices) · 2021-08-04
- HighCLARITI 1 DAY TORIC Contact Lenses Recalled Due to Axis Mark Misalignment
FDA (Devices) · 2021-08-04
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