enVista Envy™ IOL (REF ENU1400)Recalls & reported problems

Bausch & Lomb Incorporated · enVista Envy hydrophobic acrylic IOL (non-preloaded) +14.00D · Class 3 · Implant

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10757770637147), received between Aug 26, 2026 and Aug 26, 2026 — classified as 1 injury.

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Recalls naming this device

Mar 27, 2025Open, Classified
In response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjunction with implantation of enVista Aspire and enVista Envy IOLs, and certain enVista monofocal lenses in the U.S.
Z-1680-2025 · Root cause: Process control · FDA record ↗

Most reported problems

Device problems

Adverse Event Without Identified Device or Use Problem1

Patient problems

Visual Disturbances1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryAug 26, 2026Adverse Event Without Identified Device or Use Problem
It was reported approximately 10 weeks after implantation of a Multifocal intraocular lens (IOL) into the patients left eye (OS) the IOL was exchanged for a monofocal lens due to the patient having intolerable dysphotopsia with the multifocal lens. Per the reporter the dysphotopsia was resolved with the lens exchange.
Patient problems: Visual Disturbances
MAUDE report 50458838 ↗

Device details

UDI-DI	`10757770637147`
Brand	enVista Envy™ IOL
Model	EN
Catalog no.	ENU1400
Company	Bausch & Lomb Incorporated
Product code	MFK · Lens, Multifocal Intraocular
Class	Class 3
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Oct 23, 2024

Device type (GMDN): Posterior-chamber intraocular lens, pseudophakic

An optical device, generally referred to as an intraocular lens (IOL), intended to be implanted permanently in the posterior chamber of the eye (ring-like space filled with aqueous humor between the iris, the crystalline lens, and the ciliary body) to replace the natural lens (crystalline lens), typically because it has been clouded by a cataract. The device is made of a synthetic material (e.g., plastic, hydrogel). Included may be a sterile, single-use, IOL injector into which this device is preloaded and ready for insertion into the eye. Disposable devices associated with implantation (e.g., IOL injector) may be included with the lens.

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.