enVista Envy™ Toric IOL ETN (REF ETNU200+220)Recalls & reported problems
Bausch & Lomb Incorporated · enVista Envy toric hydrophobic acrylic IOL (non-preloaded) +22.00D SE / +2.00D 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
- 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 10757770641465), received between Jan 15, 2026 and Jan 15, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Device Dislodged or Dislocated1
Patient problems
- Capsular Contracture1
- Inflammation1
- Visual Impairment1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 15, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT APPROXIMATELY ONE MONTH AFTER IMPLANTATION OF AN INTRAOCULAR (IOL) LENS IN THE LEFT EYE (OS), THE SURGEON NOTED SUPERIOR DECENTRATION OF THE IOL AND CAPSULAR PHIMOSIS DURING SLIT LAMP EXAMINATION. THE PATIENT'S BEST CORRECTED VISUAL ACUITY (BCVA) DECREASED FROM 20/20 TO 20/25. APPROXIMATELY SIX WEEKS AFTER ONSET OF THE ISSUE, THE IOL WAS EXCHANGED FOR THE SAME MODEL WITH A DIFFERENT DIOPTER. ONE WEEK FOLLOWING THE EXCHANGE PROCEDURE, A YAG LASER CAPSULOTOMY WAS PERFORMED. THE PATIENT SUBSEQUENTLY RECOVERED. ACCORDING TO THE SURGEON, THE MOST LIKELY CAUSE OF THE EVENT WAS A CHRONIC INFLAMMATORY STIMULUS FROM THE LENS, NOTING FINDINGS OF 1+ CELLS ON POSTOPERATIVE DAY 1 AND AT THE TIME OF YAG TREATMENT. THE FOLLOWING MEDICATIONS WERE PRESCRIBED FOR USE AT HOME POST-OPERATIVELY: PROLENSA QD X 4 WEEKS. PRED 1% QID X 4 WEEKS-TAPER.
Patient problems: Capsular Contracture; Inflammation; Visual Impairment
MAUDE report 24085077 ↗
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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