enVista Envy™ IOL (REF ENU1000)Recalls & reported problems
Bausch & Lomb Incorporated · enVista Envy hydrophobic acrylic IOL (non-preloaded) +10.00D · Class 3 · Implant
Data updated Oct 13, 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 10757770637079), received between Apr 7, 2026 and Apr 7, 2026 — classified as 1 injury.
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. 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
- Insufficient Device Problem Information1
Patient problems
- Corneal Edema1
- Hypopyon1
- Posterior Capsule Opacification1
- Toxic Anterior Segment Syndrome (TASS)1
- Visual Impairment1
- Vitreous Floaters1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 7, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT 1 DAY AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE RIGHT EYE (OD), THE PATIENT PRESENTED AT THE POSTOPERATIVE APPOINTMENT WITH THE CHIEF COMPLAINT OF AN INABILITY TO SEE. SLIT LAMP EXAMINATION IDENTIFIED 4+ CORNEAL EDEMA. INTRAVITREAL INJECTIONS OF VANCOMYCIN AND CEFTAZIDIME WERE ADMINISTERED THE SAME DAY. CULTURE AND SENSITIVITY TESTING REVEALED NO ORGANISMS, WITH MODERATE WHITE BLOOD CELLS PRESENT. THE RETINA SPECIALIST, WHO MANAGED THE PATIENT POSTOPERATIVELY, DOCUMENTED A DIFFERENTIAL DIAGNOSIS OF TOXIC ANTERIOR SEGMENT SYNDROME (TASS) VERSUS ENDOPHTHALMITIS. AT THE 1-WEEK POSTOPERATIVE VISIT, SLIT LAMP FINDINGS SHOWED IMPROVEMENT, FIBRIN MEMBRANE AND HYPOPYON WERE NO LONGER PRESENT. AT THE 2-WEEK POSTOPERATIVE VISIT, THE PATIENT REPORTED INTERMITTENT BLURRY VISION. CLINICAL EXAMINATION CONTINUED TO SHOW IMPROVEMENT, INCLUDING DECREASED VITREOUS DEBRIS AND A CLEAR CORNEA. AT APPROXIMATELY SEVEN WEEKS POSTOPERATIVE, THE PATIENT DEMONSTRATED CONTINUED CLINICAL IMPROVEMENT, THE VITREOUS WAS NOTED TO BE CLEAR WITHOUT HEMORRHAGE, CELLS, OR PIGMENT. THE PATIENT WAS DIAGNOSED WITH POSTERIOR CAPSULE OPACIFICATION (PCO). AT 4.5 MONTHS POSTOPERATIVE, THE
Patient problems: Corneal Edema; Hypopyon; Posterior Capsule Opacification; Toxic Anterior Segment Syndrome (TASS); Visual Impairment; Vitreous Floaters
MAUDE report 24804434 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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