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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Contact Lenses & Vision

CooperVision, Inc.: Biofinity Soft Contact Lenses Recalled Due to Incorrect Prescription Power

Agency Publication Date: September 30, 2024
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Summary

CooperVision, Inc. is recalling 3,050 units of Biofinity XR Toric and Biofinity Toric Multifocal soft contact lenses because they were manufactured with a misaligned axis. This defect results in the lenses having the incorrect prescription power, which can lead to poor visual acuity and blurred vision for the wearer. Consumers who use these lenses should check their lot numbers against the affected list and contact their eye care professional.

Risk

The misaligned axis causes the lens to provide incorrect vision correction, which may lead to significant blurred vision or poor visual clarity while wearing the product. This can result in eye strain or potential hazards during activities requiring clear sight, such as driving or operating machinery.

What You Should Do

  1. Check your contact lens packaging for the following product names: BIOFINITY XR TORIC Lenses or Biofinity Toric Multifocal Lenses.
  2. Verify the Lot Number on your box or individual lens blister pack. For Biofinity XR Toric, look for lot numbers starting with RD (e.g., RD0122830, RD0122954) or RE (e.g., RE0071577, RE0071578). For Biofinity Toric Multifocal, look for lot numbers starting with RB (e.g., RB0444532, RB0450357) or RC (e.g., RC1241675, RC1241913).
  3. If your lot number matches any of the hundreds of affected codes listed in the product section, stop using those specific lenses immediately.
  4. Contact your eye care provider or CooperVision, Inc. to discuss the issue and arrange for replacement lenses or further instructions regarding the recall.
  5. Contact your healthcare provider or the manufacturer for further instructions and potential refund.
  6. For additional questions, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Healthcare provider or manufacturer coordination

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: BIOFINITY XR TORIC Lenses - Soft Contact lenses
Model / REF:
Recall #: Z-3310-2024
Lot Numbers (134):
RD0122830
RD0122954
RD0122963
RD0123016
RD0123055
RD0123135
RD0123147
RD0123159
RD0123160
RD0123172
RD0123187
RD0123193
RD0123197
RD0123206
RD0123212
RD0123250
RD0123254
RD0123261
RD0123265
RD0123268
RD0123284
RD0123294
RD0123307
RD0123321
RD0123323
RD0123327
RD0123346
RD0123347
RD0123379
RD0123382
RD0123404
RD0123405
RD0123408
RD0123419
RD0123428
RD0123433
RD0123442
RD0123488
RD0123492
RD0123499
RD0123507
RD0123535
RD0123551
RD0123587
RD0123595
RD0123610
RD0123615
RD0123619
RD0123628
RD0123646
Product: Biofinity Toric Multifocal Lenses - Soft Contact lenses
Model / REF:
Recall #: Z-3311-2024
Lot Numbers (584):
RB0444532
RB0450357
RB0450370
RB0450372
RB0450378
RB0450379
RB0450407
RB0450419
RB0450422
RB0450429
RB0450438
RB0450446
RB0450455
RB0450457
RB0450465
RB0450466
RB0450477
RB0450478
RB0450496
RB0450501
RB0450504
RB0450542
RB0450547
RB0450548
RB0450560
RB0450561
RB0450575
RB0450594
RB0450613
RB0450625
RB0450636
RB0450646
RB0450649
RB0450653
RB0450657
RB0450659
RB0450686
RB0450687
RB0450688
RB0450691
RB0450693
RB0450694
RB0450695
RB0450697
RB0450699
RB0450701
RB0450702
RB0450707
RB0450708
RB0450709

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95299
Status: Active
Manufacturer: CooperVision, Inc.
Sold By: Eye care professionals; authorized distributors
Manufactured In: United States
Units Affected: 2 products (607 lenses; 2443 lenses)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.