CooperVision, Inc. 2023-03-08 Health serious FDA
Health · FDA · Recall #FDA-Z-1197-2023
Biofinity XR Toric 6-pack- Soft (hydrophilic) Contact Lens (extended wear) Recall
Issued March 8, 2023 · CooperVision, Inc.
In March 2023, CooperVision, Inc. recalled the Biofinity XR Toric 6-pack- Soft (hydrophilic) Contact Lens (extended wear), a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Manufactured with misaligned axis resulting in lenses with the incorrect power, users may experience poor visual acuity
What you should do
- 1 Stop using Biofinity XR Toric 6-pack- Soft (hydrophilic) Contact Lens (extended wear) right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact CooperVision, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- CooperVision, Inc.
- Category
- Health
- Recall date
- March 8, 2023
- Units affected
- Not reported
- Sold at
- US Nationwide distribution in the states of CA, OH, NC, PA.
- Recall number
- FDA-Z-1197-2023
- Made in
- United States
- Issuing agency
- FDA
In context
- CooperVision, Inc. has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.