CLASS II ONGOING Device recall · Reported 8 Mar 2023 · FDA Enforcement Report
Biofinity XR Toric Single Diagnostic lens- Soft recalled by CooperVision
CooperVision is recalling Biofinity XR Toric Single Diagnostic lens- Soft (hydrophilic) Contact Lens (extended wear), distributed nationwide in the US. The recall was initiated on 26 Jan 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1198-2023
- FDA event ID
- 91607
- Recalling firm
- CooperVision, West Henrietta, NY
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 26 Jan 2023
- FDA classified
- 1 Mar 2023
- Reported
- 8 Mar 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 26 Jan 2023 | Recall initiated by company | |
| 1 Mar 2023 | Classified by FDA | +34 days |
| 8 Mar 2023 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Manufactured with misaligned axis resulting in lenses with the incorrect power, users may experience poor visual acuity
Product as listed by the FDA
Biofinity XR Toric Single Diagnostic lens- Soft (hydrophilic) Contact Lens (extended wear)
Where it was distributed
US Nationwide distribution in the states of CA, OH, NC, PA.
Questions about this recall
Is Biofinity XR Toric Single Diagnostic lens- Soft (hydrophilic) Contact Lens (extended wear) recalled?
Yes. CooperVision recalled Biofinity XR Toric Single Diagnostic lens- Soft (hydrophilic) Contact Lens (extended wear) on 26 Jan 2023. The recall is Class II and its status is Ongoing. Recall number Z-1198-2023.
Why was it recalled?
Manufactured with misaligned axis resulting in lenses with the incorrect power, users may experience poor visual acuity
Which lots are affected?
UDI: N/A Lot Numbers: R24395839, R24406094, R24409954
Where was it sold?
US Nationwide distribution in the states of CA, OH, NC, PA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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