# Major Recall Alert: enVista Aspire™, enVista Envy™ and Certain enVista® Monofocal Intraocular Lenses Recalled Due to Increased Frequency of Reports of Toxic Anterior Segment Syndrome
Bausch + Lomb Corporation, a trusted global leader in eye care, has issued a **voluntary recall** of several intraocular lens (IOL) models from its enVista platform. This decision comes in response to an increased frequency of reports of **toxic anterior segment syndrome (TASS)**. TASS is a rare and serious complication that can occur after cataract surgery. The recall includes multiple enVista Aspire™, enVista Envy™, and certain enVista® Monofocal IOL models distributed in the United States.
Read on for key details about this urgent recall, the importance of swift action, and what patients and healthcare providers should do to stay safe.
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## Why This Recall is Important
Bausch + Lomb, known for its commitment to patient safety, identified an unexpected rise in TASS-related reports linked to their enVista platform. Although TASS cases associated with these lens models were successfully treated without requiring lens removal, TASS carries the risk of significant eye inflammation, requiring immediate attention for optimal outcomes.
TASS typically develops after cataract surgery, appearing **12–48 hours post-operation**, resulting in inflammatory symptoms within the eye. While TASS cases linked to enVista lenses represent only **1-2% of implanted lenses**, Bausch + Lomb has taken the proactive step of recalling all affected models to protect the trust and safety of its patients.
In the words of Brent Saunders, the Chairman and CEO of Bausch + Lomb:
> *“Surgeons and patients trust Bausch + Lomb, and I believe that this voluntary recall is the best thing we can do to honor that trust.”*
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## Details of the Recall
Here’s everything you need to know about the enVista IOL recall:
- **Product Names**:
- enVista Aspire™
- enVista Aspire Toric
- enVista Envy™
- enVista Envy Toric
- enVista Monofocal
- enVista Monofocal Toric
- **Reason for Recall**: Increased frequency of **toxic anterior segment syndrome (TASS)** reports following cataract surgeries.
- **Action Taken**: Voluntary recall initiated by Bausch + Lomb to prevent further complications while investigating the root cause.
- **Current Outcome**: All reported TASS cases were treated and resolved successfully, with no lens removals required.
Healthcare professionals and organizations are being contacted directly by Bausch + Lomb with detailed instructions on safely returning affected products.
For the official recall notice, visit the FDA’s website [here](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bausch-lomb-announces-voluntary-recall-envista-aspiretm-envista-envytm-and-certain-envistar).
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## What You Should Do
### For Patients:
If you’ve undergone cataract surgery recently and suspect you may have received one of the recalled lenses, take the following steps:
- **Monitor Symptoms**: Pay close attention to symptoms of TASS, which may include eye pain, blurred vision, or redness, appearing within 48 hours of surgery.
- **Contact Your Doctor**: If you experience discomfort or worsening symptoms, contact your eye care professional immediately for evaluation.
### For Eye Care Professionals:
- **Patient Monitoring**: Closely monitor post-operative patients for at least 48 hours after surgery. Be prepared to address any inflammatory reactions promptly.
- **Return Affected Products**: Follow instructions provided by Bausch + Lomb for returning recalled IOLs.
- **Report Adverse Events**: To report any further complications, contact Bausch + Lomb Customer Service at **1-800-338-2020** or reach out to the FDA’s **MedWatch Program** via **1-800-332-1088**.
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For more details on this recall, visit the official FDA recall notice [here](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bausch-lomb-announces-voluntary-recall-envista-aspiretm-envista-envytm-and-certain-envistar).
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