enVista Envy™ IOL (REF ENU2000)Recalls & reported problems
Bausch & Lomb Incorporated · enVista Envy hydrophobic acrylic IOL (non-preloaded) +20.00D · Class 3 · Implant
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10757770636485), received between Mar 4, 2026 and Jun 24, 2026 — classified as 2 injuries.
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
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Diplopia/Double Vision1
- Halo1
- Photophobia1
- Visual Disturbances1
- Visual Impairment1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 24, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT APPROXIMATELY TWO WEEKS AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) IN THE PATIENT'S RIGHT EYE (OD), THE PATIENT COMPLAINED OF VISUAL DISTURBANCES INCLUDING DOUBLING AND SHADOWING OF LETTERS AND LIGHTS, LIGHT RELATED GLARE AND HALOS, AND GHOSTING OF OBJECTS SUCH AS CARS. APPROXIMATELY THREE MONTHS AFTER SYMPTOM ONSET, THE IOL WAS EXCHANGED FOR A DIFFERENT MODEL. IN THE SURGEON¿S OPINION, THE MOST LIKELY CAUSE OF EVENT WAS VISUAL DISTURBANCE WITH THE MULTIFOCAL IOL. THE PATIENT HAS SINCE RECOVERED. THIS IS THE REPORT FOR THE RIGHT EYE (OD). LEFT EYE (OS) REFERENCE: 0001313525-2026-00087.
Patient problems: Diplopia/Double Vision; Halo; Photophobia; Visual Disturbances
MAUDE report 25612500 ↗InjuryMar 4, 2026Adverse Event Without Identified Device or Use Problem
A SURGERY CENTER REPORTED THAT A PATIENT HAD TWO IOL¿S EXPLANTED DUE TO MALADAPTATION TO MULTIFOCAL INTRAOCULAR LENS (IOL). A LAL+ IOL FROM A DIFFERENT MANUFACTURER WAS IMPLANTED. THIS REPORT IS FOR IOL 2 OF 2.
Patient problems: Visual Impairment
MAUDE report 24507043 ↗
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.