Bausch + Lomb Recalls enVista Intraocular Lenses Due to Safety Concern, USA

United States

Bausch + Lomb Corporation a leading global eye health company dedicated to helping people see better to live better, today announced a voluntary recall of intraocular lenses (IOLs) on its enVista platform. This action was taken after the company received reports of complications, the cause of which could not immediately be explained. The affected products were distributed across US.

The recall is in response to an increased number of reports of toxic anterior segment syndrome (TASS), and includes all lots of the following enVista Aspire, enVista Aspire Toric, enVista Envy and enVista Envy Toric, as well as enVista monofocal and enVista monofocal Toric IOL models in the U.S.

Impacted Product:

- Model Description: enVista Monofocal IOL, Model Identifier: All models starting with EE, UDI-DI: Complete list of UDI-DI mentioned in a link below

- Model Description: enVista Aspire IOL, Model Identifier: All models starting with EA

- Model Description: enVista Envy IOL, Model Identifier: All models starting with EN

- Model Description: enVista Monofocal Toric IOL, Model Identifier: All models starting with ETE

- Model Description: enVista Aspire Toric IOL, Model Identifier: All models starting with ETA

- Model Description: enVista Envy Toric IOL, Model Identifier: All models starting with ETN

TASS, a potential complication in any cataract surgery, is an inflammatory reaction inside the eye that can have a variety of causes. When it occurs, this complication typically appears 12 – 48 hours after eye surgery. All enVista TASS cases reported to Bausch + Lomb to date responded quickly to treatment, and none have required removal of the lens.

For Patients: Cataract surgery patients experiencing eye discomfort should contact their eyecare professional immediately.

For Eyecare Professionals: Please continue to closely monitor cataract surgery patients for at least 48 hours after surgery. Please instruct patients with new or worsening symptoms to contact your office immediately.

UDI-DI: www.bausch.com/globalassets/pdf/recall/gudid-info-for-envista-iol-family.pdf
Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bausch-lomb-announces-voluntary-recall-envista-aspiretm-envista-envytm-and-certain-envistar