COMPANY ANNOUNCEMENT
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
Read AnnouncementSummary
- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Medical Devices
- Reason for Announcement:
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Recall Reason Description
Increased frequency of reports of toxic anterior segment syndrome
- Company Name:
- Bausch + Lomb Corporation
- Brand Name:
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Brand Name(s)
- Product Description:
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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.
