Intraocular Lens Recalled Due to Toxic Anterior Segment Syndrome Reports

Plain-English summary

Bausch & Lomb Surgical, Inc. is recalling enVista intraocular lenses (IOLs) following an increased number of reports of toxic anterior segment syndrome (TASS) in conjunction with implantation of certain enVista models in the United States. The affected products include enVista Monofocal IOL (models starting with EE), enVista Aspire IOL (models starting with EA), enVista Monofocal Toric IOL (models starting with ETE), and enVista Aspire Toric IOL (models starting with ETA).

TASS is an anterior eye inflammation that can occur following intraocular lens implantation. The agency classified this as a Class I recall, indicating a serious health hazard.

Approximately 236,840 units have been distributed worldwide, including nationwide distribution in the United States, Puerto Rico, Guam, and multiple countries across North America, Europe, and other regions. Patients who have had these lenses implanted and experience eye symptoms should contact their eye care provider immediately.

The recalled product

Product

Intraocular lens. enVista Monofocal IOL, All models starting with EE; enVista Aspire IOL, All models starting with EA; enVista Monofocal Toric IOL, All models starting with ETE; enVista Aspire Toric IOL, All models starting with ETA;

Manufacturer

Bausch & Lomb Surgical, Inc.

Category

Medical Device — Ophthalmic / Intraocular Lens

Hazard

• toxic-anterior-segment-syndrome
• inflammation

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distributed nationwide across the United States.

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