CLASS II Device recall · Reported 4 Aug 2021 · FDA Enforcement Report
Sofmed Breathables 1 Day Toric Power-07.00 -1.75/ 170 Daily recalled
CooperVision is recalling Sofmed Breathables 1 Day Toric Power-07.00 -1.75/ 170 Daily Disposable Contact Lens with, distributed nationwide in the US. The recall was initiated on 19 May 2021 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-2154-2021
- FDA event ID
- 88096
- Recalling firm
- CooperVision, West Henrietta, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 May 2021
- FDA classified
- 27 Jul 2021
- Reported
- 4 Aug 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Contact Lenses & Eye Devices
Timeline
| 19 May 2021 | Recall initiated by company | |
| 27 Jul 2021 | Classified by FDA | +69 days |
| 4 Aug 2021 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Misaligned placement of an axis mark can cause the patient to experience blurred vision
Product as listed by the FDA
SOFMED BREATHABLES 1 DAY TORIC Power-07.00 -1.75/ 170 Daily Disposable Contact Lens with UV blocker
Where it was distributed
Worldwide distribution - US Nationwide distribution in the states of FL, NY, TN, OH, NC, WI and the countries of France, United Arab Emirates, Brazil, Australia, New Zealand, Taiwan, Canada.
Nationwide FloridaNorth CarolinaNew YorkOhioTennesseeWisconsin
Questions about this recall
Is Sofmed Breathables 1 Day Toric Power-07.00 -1.75/ 170 Daily Disposable Contact Lens with recalled?
Yes. CooperVision recalled Sofmed Breathables 1 Day Toric Power-07.00 -1.75/ 170 Daily Disposable Contact Lens with on 19 May 2021. The recall is Class II and its status is Terminated. Recall number Z-2154-2021.
Why was it recalled?
Misaligned placement of an axis mark can cause the patient to experience blurred vision
Which lots are affected?
Lot Number: W0106167
Where was it sold?
Worldwide distribution - US Nationwide distribution in the states of FL, NY, TN, OH, NC, WI and the countries of France, United Arab Emirates, Brazil, Australia, New Zealand, Taiwan, Canada.
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.
More recalls from CooperVision
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|---|---|---|---|---|---|
| Device | CLASS II | Sofmed Breathables, (stenfilcon A) contact lens recalled by CooperVision | CooperVision | Mold | Nationwide |
| Device | CLASS II | Voyant 1-Day Premium Toric, (stenfilcon A) contact lens recalled | CooperVision | Mold | Nationwide |
| Device | CLASS II | MyDay Toric, stenfilcon A) Contact Lens recalled by CooperVision | CooperVision | Mold | Nationwide |
| Device | CLASS II | Biofinity Toric Multifocal Contact Lens recalled by CooperVision | CooperVision | Sterility | Nationwide |
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Other Contact Lenses & Eye Devices recalls
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|---|---|---|---|---|---|
| Device | CLASS II | Tecnis Eyhance Iol with Tecnis Simplicity" Delivery System recalled | AMO Puerto Rico Manufacturing | Sterility | Nationwide |
| Device | CLASS II | Alcon PRECISION1 One-Day Contact Lenses, -2.25D recalled | Alcon Research | Sterility | 19 states |
| Device | CLASS II | Sofmed Breathables, (stenfilcon A) contact lens recalled by CooperVision | CooperVision | Mold | Nationwide |
| Device | CLASS II | Voyant 1-Day Premium Toric, (stenfilcon A) contact lens recalled | CooperVision | Mold | Nationwide |
| Device | CLASS II | MyDay Toric, stenfilcon A) Contact Lens recalled by CooperVision | CooperVision | Mold | Nationwide |