enVista Envy™ IOL (REF ENU1150)Recalls & reported problems

Bausch & Lomb Incorporated · enVista Envy hydrophobic acrylic IOL (non-preloaded) +11.50D · Class 3 · Implant

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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 10757770637109), received between Jun 18, 2025 and Jun 18, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 · Recall details · FDA record ↗

Most reported problems

Device problems

Manufacturing, Packaging or Shipping Problem1

Patient problems

Hypopyon1
Intraocular Pressure Increased1
Toxic Anterior Segment Syndrome (TASS)1
Visual Impairment1
Vitreous Floaters1

Recent adverse event reports

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

InjuryJun 18, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT 1 DAY AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE LEFT EYE (OS), THE PATIENT PRESENTED WITH 3+ CELLS, FIBRIN, AND HYPOPYON. PATIENT'S BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) DECREASED FROM 20/20-1 TO 20/60-1. BASED ON THE FINDINGS, THE SURGEON CONCLUDED THE CAUSE AS TOXIC ANTERIOR SEGMENT SYNDROME (TASS) AND INCREASED STEROID DROPS. AT THE PATIENT'S 1-MONTH POST-OP VISIT, INFLAMMATION HAD RESOLVED WITH UNCORRECTED DISTANCE VISUAL ACUITY (UCDVA) OF 20/20 AND UNCORRECTED NEAR VISUAL ACUITY (UCNVA) OF J1. DUE TO FINDINGS OF VITREOUS DEBRIS/VEIL, THE PATIENT WAS REFERRED TO RETINA FOR AN EVALUATION. APPROXIMATELY ONE WEEK LATER, A PARS PLANA VITRECTOMY (PPV) WAS PERFORMED DUE TO RESIDUAL VITREOUS DEBRIS. ON WEEK AFTER PPV, THE VITREOUS WAS FOUND TO BE CLEAR. IN THE SURGEON'S OPINION, THE MOST LIKELY CAUSE OF THE EVENT IS THE IOL. PATIENT OUTCOME IS GOOD. SURGEON WILL CONTINUE TO MONITOR INTRAOCULAR PRESSURE. MEDICATIONS PRESCRIBED FOR USE AT HOME POST-OPERATIVELY: PRED ACETATE 1% 1 GTT HOURLY. COSOPT 1 GTT BID (ADDED 21-MAR-2025). BRIMONIDINE 0.2% 1GTT BID (ADDED 22-MAR-2025).
Patient problems: Hypopyon; Intraocular Pressure Increased; Toxic Anterior Segment Syndrome (TASS); Visual Impairment; Vitreous Floaters
MAUDE report 22287524 ↗

Device details

UDI-DI	`10757770637109`
Brand	enVista Envy™ IOL
Model	EN
Catalog no.	ENU1150
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.

Other Lens, Multifocal Intraocular devices

Clareon™ CNA0T0
Alcon Laboratories, Inc. · Lens, multifocal intraocular
144 reports
Clareon™ CNA0T0
Alcon Laboratories, Inc. · Lens, multifocal intraocular
1 recall66 reports
Clareon™ CNA0T0
Alcon Laboratories, Inc. · Lens, multifocal intraocular
113 reports
Clareon™ CNA0T0
Alcon Laboratories, Inc. · Lens, multifocal intraocular
112 reports
Clareon™ CNA0T0
Alcon Laboratories, Inc. · Lens, multifocal intraocular
110 reports
Clareon™ CNA0T0
Alcon Laboratories, Inc. · Lens, multifocal intraocular
107 reports
Clareon™ CNA0T0
Alcon Laboratories, Inc. · Lens, multifocal intraocular
104 reports
Clareon™ CNA0T0
Alcon Laboratories, Inc. · Lens, multifocal intraocular
93 reports

All Lens, Multifocal Intraocular devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page