enVista Hydrophobic Acrylic IOL recall in Canada: performance issue
In plain language
This recall involves enVista Hydrophobic Acrylic Intraocular Lenses (IOLs) sold in Canada. They are being recalled due to a performance issue that may lead to Toxic Anterior Segment Syndrome (TASS). Stop using the product and contact the manufacturer for more information.
What to do
- Stop using the product immediately.
- Contact the manufacturer if you require additional information.
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Affected products
enVista® Hydrophobic Acrylic IOL Non Preloaded
Model: Models starting with EE
Lot: More than 10 numbers, contact manufacturer.
enVista® Envy™ Hydrophobic Acrylic IOL (Nonpreloaded)
Model: Models starting with EN
Lot: More than 10 numbers, contact manufacturer.
enVista® Envy™ Toric Hydrophobic Acrylic IOL (Nonpreloaded)
Model: Models starting with ETN
Lot: More than 10 numbers, contact manufacturer.
enVista® Toric Hydrophobic Acrylic IOL (Nonpreloaded)
Model: Models starting with ETE
Lot: More than 10 numbers, contact manufacturer.
enVista MX60PL
Model: MXPLC2150
Lot: ER00212
Why this matters
Performance issue
Do I have this product?
This recall only applies to specific products. Follow the steps below to check.
- 1
Check the product name
Make sure your product name matches one of the affected products listed above.
- 2
Check the lot number
Lot numbers identify specific production batches.
Affected lots: ER00212, More than 10 numbers, contact manufacturer.
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: MXPLC2150, Models starting with EE, Models starting with EN, Models starting with ETE, Models starting with ETN
If your product matches one or more of the details above, it may be affected by this recall.
If your product does not match these details, it is not affected by this recall.
When in doubt, always check the official notice.
Frequently Asked Questions
Why was this product recalled?
Performance issue
What should consumers do?
Stop using the product immediately. Contact the manufacturer if you require additional information.
Where was the product sold?
This product was sold in Canada. For specific retailers or distribution areas, please check the official recall notice linked on this page.
Is there a health risk?
Yes, there may be a health risk. Performance issue
When was this product recalled?
This product was recalled on April 28, 2025.
Is the Bausch & Lomb Inc. brand affected by this recall?
Yes, Bausch & Lomb Inc. products are affected by this recall. This recall involves enVista Hydrophobic Acrylic Intraocular Lenses (IOLs) sold in Canada. They are being recalled due to a performance issue that may lead to Toxic Anterior Segment Syndrome (TASS). Stop using the product and contact the manufacturer for more information.