Recall MonitorHealth Products
enVista® Hydrophobic Acrylic IOL
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Ophthalmology
Product: enVista® Hydrophobic Acrylic IOL
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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) 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. No other Bausch + Lomb products or lots distributed in Canada are impacted by this recall. Recall start date: March 28, 2025