enVista Envy™ Toric IOL ETN (REF ETNU250+225)Recalls & reported problems
Bausch & Lomb Incorporated · enVista Envy toric hydrophobic acrylic IOL (non-preloaded) +22.50D SE / +2.50D 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
- 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 10757770642042), received between Jan 16, 2026 and Jan 16, 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
- Blurred Vision1
- Capsular Contracture1
- Halo1
- Inflammation1
- Zonular Dehiscence1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 16, 2026Device Dislodged or Dislocated
THIS EVENT WAS ORIGINALLY REPORTED AS EVENT #2 FOR PATIENT IDENTIFIER (A)(1) (B)(6). SINCE PATIENT IDENTIFIERS WERE LATER PROVIDED, THE CASE HAS BEEN REASSIGNED TO PATIENT IDENTIFIER (A)(1) (B)(6). ADDITIONAL INFORMATION WAS RECEIVED INDICATING SIX MONTHS AFTER IMPLANTATION OF THE IOL IN THE PATIENT'S LEFT EYE (OS), THE PATIENT REPORTED THAT VISION WAS NO LONGER AS CRISP AS THREE MONTHS PRIOR. EXAMINATION AT THAT TIME IDENTIFIED INFERIOR DECENTRATION OF THE IOL AND PHIMOSIS OF THE ANTERIOR CAPSULE. NINE MONTHS POST-IMPLANTATION, DURING THE LENS EXCHANGE, A CAPSULAR TENSION RING WAS IMPLANTED DUE TO ZONULAR DEHISCENCE. ACCORDING TO THE SURGEON, THE MOST LIKELY CAUSE OF THE EVENT WAS A CHRONIC INFLAMMATORY STIMULUS FROM THE LENS. FOLLOWING THE EXCHANGE, THE SURGEON DISCUSSED WITH THE PATIENT THE OPTIONS OF PRK OR LASIK TO ENHANCE DISTANCE VISION. THE PATIENT CONTINUES TO REPORT SEEING HALOS, WHICH THE SURGEON ATTRIBUTES TO THE PATIENT'S INABILITY TO ADAPT TO THE LENS DESIGN.
Patient problems: Blurred Vision; Capsular Contracture; Halo; Inflammation; Zonular Dehiscence
MAUDE report 24095015 ↗
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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