enVista® Hydrophobic Acrylic IOL
Brand(s)
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 |
| enVista MX60PL | ER00212 | MXPLC2150 |
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) cased detected in complaints. Users should immediately stop implanting the affected IOL models. Only certain IOL lots manufactured from September 2024 to March 2025 are impacted.
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
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