enVista Envy™ IOL (REF ENU1350)Recalls & reported problems
Bausch & Lomb Incorporated · enVista Envy hydrophobic acrylic IOL (non-preloaded) +13.50D · Class 3 · Implant
All models of enVista Envy IOL (53)
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
- 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 10757770637130), received between May 29, 2026 and May 29, 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 · Recall details · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Visual Disturbances2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 29, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT APPROXIMATELY FOUR MONTHS AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) IN THE LEFT EYE (OS), THE IOL WAS EXCHANGED FOR A DIFFERENT MODEL LENS DUE TO THE PATIENT EXPERIENCING DEBILITATING DYSPHOTOPSIA. IN THE SURGEON'S OPINION, THE MOST LIKELY CAUSE OF THE EVENT WAS THE LENS. THE PATIENT'S OUTCOME IS GOOD. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED. THIS REPORT IS FOR LEFT EYE (OS). RIGHT EYE (OD) REFERENCE: (B)(4).
Patient problems: Visual Disturbances
MAUDE report 25334822 ↗InjuryMay 29, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT APPROXIMATELY 7 MONTHS AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) IN THE RIGHT EYE (OD), THE IOL WAS EXCHANGED FOR A DIFFERENT MODEL LENS DUE TO THE PATIENT EXPERIENCING DEBILITATING DYSPHOTOPSIA. IN THE SURGEON'S OPINION, THE MOST LIKELY CAUSE OF THE EVENT WAS THE LENS. THE PATIENT'S OUTCOME IS GOOD. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED. THIS REPORT IS FOR RIGHT EYE (OD). LEFT EYE (OS) REFERENCE: (B)(4)
Patient problems: Visual Disturbances
MAUDE report 25334788 ↗
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 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.
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