Washington, D.C., USA- January 13, 2020: FDA Sign at its headquarters in Washington DC. The Food and Drug Administration (FDA or USFDA) is a federal agency of the USA.
Rochester, NY – Bausch + Lomb Corporation (NYSE/TSX: BLCO), has issued a voluntary recall of several models of its enVista® intraocular lenses (IOLs) in the U.S. due to an increased risk of toxic anterior segment syndrome (TASS), a rare but serious inflammatory eye condition.
The recall, announced on April 3 and published by the U.S. Food and Drug Administration (FDA) on April 7, affects all lots of the enVista Aspire™, enVista Aspire Toric, enVista Envy™, enVista Envy Toric, enVista Monofocal, and enVista Monofocal Toric IOLs. The decision follows reports of post-surgical complications, though the exact cause remains under investigation.
Patient Safety a Top Priority
Brent Saunders, chairman and CEO of Bausch + Lomb, emphasized that patient safety drove the recall. “Surgeons and patients trust Bausch + Lomb, and this voluntary recall is the best way to honor that trust,” he said.
TASS typically develops within 12 to 48 hours after cataract surgery and can cause eye inflammation. While all reported cases responded well to treatment—with no lens removals required—the company is taking precautionary action. Saunders noted that the complication rate remains low, affecting only 1-2% of implanted lenses, with positive outcomes for affected patients.
Impacted Product
| Model Description | Model Identifier: | Lots | UDI-DI |
| enVista Monofocal IOL | All models starting with EE | ALL | Click hereExternal Link Disclaimer for UDI list |
| enVista Aspire IOL | All models starting with EA | ||
| enVista Envy IOL | All models starting with EN | ||
| enVista Monofocal Toric IOL | All models starting with ETE | ||
| enVista Aspire Toric IOL | All models starting with ETA | ||
| enVista Envy Toric IOL | All models starting with ETN |
Next Steps for Patients and Doctors
- Patients who have undergone recent cataract surgery and experience discomfort, redness, or vision changes should contact their eye care provider immediately.
- Healthcare professionals are advised to monitor patients closely for at least 48 hours post-surgery and report any adverse events to Bausch + Lomb or the FDA’s MedWatch program.
Bausch + Lomb is working to identify the root cause and aims to return the enVista platform to the market soon. Affected products should be returned per the company’s instructions.
For more details, visit the FDA recall notice or contact Bausch + Lomb Customer Service at 1-800-338-2020.
This recall is being conducted in cooperation with the FDA, which has posted the announcement as a public service but does not endorse the product or company.
Media Contact:
Bausch + Lomb Corporate Communications
Phone: 1-800-338-2020
Email: customer.service@bausch.com
For additional updates, follow @BauschLomb on social media.
