enVista Envy™ Toric IOL ETN (REF ETNU150+195)Recalls & reported problems
Bausch & Lomb Incorporated · enVista Envy toric hydrophobic acrylic IOL (non-preloaded) +19.50D SE / +1.50D CYL · Class 3 · Implant
All models of enVista Envy Toric IOL (513)
Data updated Oct 18, 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 10757770640840), received between Apr 23, 2025 and Apr 21, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 18, 2026.
Reports received per month
Recalls naming this device
- Mar 27, 2025Class IOpen, 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 Problem1
- Insufficient Device Problem Information1
- Manufacturing, Packaging or Shipping Problem1
Patient problems
- Eye Pain1
- Inflammation1
- Toxic Anterior Segment Syndrome (TASS)1
- 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.
InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED DYSPHOTOPSIA IN THE RIGHT EYE (OD) FOLLOWING AN INTRAOCULAR LENS (IOL) EXCHANGE. THE PATIENT HAD A FAVORABLE OUTCOME WITH THE MONOFOCAL IOL IN THE FELLOW EYE AND REQUESTED THAT THE RIGHT EYE IOL BE EXCHANGED FOR A MONOFOCAL AS WELL. A SECOND LENS EXCHANGE WAS SUBSEQUENTLY PERFORMED APPROXIMATELY TWO MONTHS AFTER THE FIRST EXCHANGE. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED.
Patient problems: Visual Disturbances
MAUDE report 24938271 ↗InjuryApr 23, 2025Manufacturing, Packaging or Shipping Problem; Insufficient Device Problem Information; Manufacturing, Packaging or Shipping Problem; Insufficient Device Problem Information
IT WAS REPORTED THAT APPROXIMATELY 3 WEEKS AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE RIGHT EYE, THE PATIENT PRESENTED WITH INFLAMMATION. SLIT LAMP FINDINGS WERE 1+ CELL IN A/C AND TRACE FLARE. PATIENT'S BCVA DROPPED FROM 20/25 TO 20/30. PATIENT HAS HAD PERSISTENT INFLAMMATION, EYE PAIN AND HAZY VISION SINCE. BASED ON THE FINDINGS THE SURGEON CONCLUDED THE CAUSE AS TOXIC ANTERIOR SEGMENT SYNDROME (TASS). THE PATIENT WAS TREATED WITH IMPRISM. FIVE MONTHS AND ONE WEEK AFTER IMPLANTATION, THE IOL WAS EXPLANTED AND ANOTHER MODEL MULTIFOCAL IOL WAS IMPLANTED. THE PATIENT'S CURRENT OUTCOME IS UNKNOWN.
Patient problems: Eye Pain; Inflammation; Toxic Anterior Segment Syndrome (TASS); Visual Impairment
MAUDE report 21896496 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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