Health product recall

enVista® Hydrophobic Acrylic IOL

Last updated

Summary

Product
enVista® Hydrophobic Acrylic IOL
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

enVista® Hydrophobic Acrylic IOL Non Preloaded

More than 10 numbers, contact manufacturer.

Models starting with EE

enVista® Envy™ Hydrophobic Acrylic IOL (Nonpreloaded)

More than 10 numbers, contact manufacturer.

Models starting with EN

enVista® Envy™ Toric Hydrophobic Acrylic IOL (Nonpreloaded)

More than 10 numbers, contact manufacturer.

Models starting with ETN

enVista® Toric Hydrophobic Acrylic IOL (Nonpreloaded)

More than 10 numbers, contact manufacturer.

Models starting with ETE

Issue

Products are being voluntary recalled out of an abundance of caution based on an increase in the number of toxic anterior segment syndrome (tass) cases detected in complaints. Users should immediately stop implanting the affected IOL models.

Recall start date: March 28, 2025

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Ophthalmology
Companies

Bausch & Lomb Inc.

1400 North Goodman Street, Rochester, New York, United States, 14609

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-77219

Get notified

Receive notifications for new and updated recalls and alerts by category.

Subscribe