Source: US Department of Health and Human Services – 3
Summary
Company Announcement Date:
April 03, 2025
FDA Publish Date:
April 07, 2025
Product Type:
Medical Devices
Reason for Announcement:
Recall Reason Description
Increased frequency of reports of toxic anterior segment syndrome
Company Name:
Bausch + Lomb Corporation
Brand Name:
Brand Name(s)
enVista Aspire
Product Description:
Product Description
enVista Aspire™, enVista Envy™ and Certain enVista® Monofocal Intraocular Lenses
Company Announcement
Bausch + Lomb Corporation (NYSE/TSX: BLCO), a leading global eye health company dedicated to helping people see better to live better, today announced a voluntary recall of intraocular lenses (IOLs) on its enVista platform. This action was taken after the company received reports of complications, the cause of which could not immediately be explained.
“As much as we believe in the enVista platform, patient safety will always be our number one priority,” said Brent Saunders, chairman and CEO, 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.”
The recall is in response to an increased number of reports of toxic anterior segment syndrome (TASS), and includes all lots of the following enVista Aspire, enVista Aspire Toric, enVista Envy and enVista Envy Toric, as well as enVista monofocal and enVista monofocal Toric IOL models in the U.S.
Impacted Product
Model Description
Model Identifier:
Lots
UDI-DI
enVista Monofocal IOL
All models starting with EE
ALL
Click here 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
TASS, a potential complication in any cataract surgery, is an inflammatory reaction inside the eye that can have a variety of causes. When it occurs, this complication typically appears 12 – 48 hours after eye surgery. All enVista TASS cases reported to Bausch + Lomb to date responded quickly to treatment, and none have required removal of the lens.
“These reports represent only 1-2% of implanted lenses, with a positive prognosis for everyone involved,” Saunders continued. “We look forward to identifying a root cause and bringing the enVista platform back to market.”
Communications to eye care professionals are underway, with instructions for product return. Click here for a message from Saunders to customers, here for a copy of the U.S. version of the recall notice and here for a TASS fact sheet.
For Patients: Cataract surgery patients experiencing eye discomfort should contact their eyecare professional immediately.
For Eyecare Professionals: Please continue to closely monitor cataract surgery patients for at least 48 hours after surgery. Please instruct patients with new or worsening symptoms to contact your office immediately.
To report an adverse event, please contact Bausch + Lomb Customer Service at 1-800-338-2020, option 1, or submit a report to U.S. FDA’s MedWatch program (call 1-800-332-1088 to request a form). For more information about this recall, please contact Bausch + Lomb Customer Service at 1-800-338-2020, option 9, 8:00 am to 4:30 pm Eastern, Monday through Friday.
Company Contact Information
Consumers:
Bausch + Lomb Customer Service
(800) 338-2020
Content current as of:
04/07/2025
Regulated Product(s)
Follow FDA