enVista Envy™ IOL (REF ENU2050)Recalls & reported problems
Bausch & Lomb Incorporated · enVista Envy hydrophobic acrylic IOL (non-preloaded) +20.50D · 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 10757770637550), received between Mar 13, 2026 and Mar 13, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Material Opacification” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
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
- Material Opacification1
Patient problems
- Insufficient Information1
- Visual Disturbances1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 13, 2026Material Opacification
ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE EVENT INVOLVED THE PATIENT'S LEFT EYE, AND THE PATIENT REPORTED EXPERIENCING A VISUAL HAZE PRIOR TO THE EXCHANGE PROCEDURE. DURING THE INTRAOCULAR LENS EXCHANGE PROCEDURE, THE SURGEON INTENDED TO USE THE SAME MODEL IOL AS THE ORIGINAL DEVICE. HOWEVER, DUE TO THE STRUCTURE OF THE CAPSULAR BAG, THE SAME MODEL COULD NOT BE IMPLANTED, AND A DIFFERENT MODEL IOL WAS USED.
Patient problems: Insufficient Information; Visual Disturbances
MAUDE report 24594367 ↗
Other Lens, Multifocal Intraocular devices
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular144 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular1 recall66 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular113 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular112 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular110 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular107 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular104 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular93 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.