CooperVision Softmed Breathables Advanced Toric contact lenses recalled for incorrect extended-wear labeling
What this means
Certain batches of CooperVision Softmed Breathables Advanced Toric contact lenses have incorrect packaging labels stating they are approved for extended wear. These lenses are designed and FDA-approved for daily wear only, not extended wear. The mislabeling could lead users to wear the lenses longer than intended.
- Check your contact lens box for a lot number matching the affected batches (listed on FDA.gov).
- If your lenses are affected, use them only for daily wear—remove them each night.
- Contact CooperVision or your eye care provider if you have questions about your lenses.
- Do not use affected lenses for overnight or extended wear.
The agency's original wording
The affected products bear an incorrect statement on the carton packaging indicating that the product is "Indicated for Extended Wear". However, this product is intended for daily wear, and the extended-wear statement should not have appeared on the affected carton labeling. This product is not approved by the U.S. Food and Drug Administration (FDA) for extended wear use.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0204-2027More CooperVision recalls
- FDA-Device2026-09-30Pearle Vision 1 day contact lenses recalled for incorrect lens power
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