| TGA Action ID |
RC-2025-RN-00357-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
enVista Monofocal Intraocular Lens (IOL) Model MX60E,
enVista Monofocal Toric Intraocular Lens (IOL) Model MX60ET,
enVista Envy Intraocular Lens (IOL) Model EN &
enVista Envy Toric Intraocular Lens (IOL) Model ETN
Multiple model and lot numbers |
| ARTG Number |
98915 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
An increased number of reports of toxic anterior segment syndrome (TASS) in conjunction with implantation of enVista Envy and two other enVista brands not available in the Australian market have triggered this Product Recall.
TASS is an inflammatory reaction inside the eye that typically appears 12 – 48 hours after eye surgery.
With TASS, a patient may experience no adverse health consequence; may need medical or surgical intervention; or could potentially experience permanent impairment of body function or permanent damage to a body structure.
The probability that the product will cause adverse health consequences/hazards is remote.
Most of the cases reported to Bausch + Lomb were mild-moderate and treated with topical medication with a few cases including intravitreal injection of antibiotics.
All enVista TASS cases reported to Bausch + Lomb to date have responded quickly to treatment, and none have required removal of the lens.
update 30/04/2025: Bausch & Lomb is broadening the scope of the Recall to add specific lots of enVista Monofocal IOLs, Models MX60E and MX60ET.
Only certain IOL lots manufactured from September 2024 to March 2025 are impacted. |
| Instructions for Customers/Users |
Customers are to stop using the product and quarantine it immediately.
Health Care Professionals are reminded to follow their usual protocols and monitor their implanted patients for adverse effects.
Once the Response Form has been received, Bausch + Lomb will notify affected customers to arrange pick up/return of the affected product.
Bausch + Lomb will also provide a credit, where applicable.
This action has been closed out on 16/09/2025. |
| Action Commencement Date |
28/03/2025 |
| Responsible Entity |
|
| Contact Information |
1800 251 150 - B+L Australia Customer Service |