enVista Aspire™ Toric IOL ETA (REF ETAU350+180)Recalls & reported problems
Bausch & Lomb Incorporated · enVista Aspire toric hydrophobic acrylic IOL (non-preloaded) +18.00D SE / +3.50D CYL · Class 3 · Implant
All models of enVista Aspire 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 10757770624529), received between Apr 9, 2025 and Apr 9, 2025 — 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. 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-1679-2025 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Blurred Vision1
- Corneal Edema1
- Endophthalmitis1
- Eye Pain1
- Hypopyon1
- Intraocular Pressure Increased1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 9, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT ONE WEEK POST-IMPLANTATION (IOL) INTO THE RIGHT EYE, THE PATIENT EXPERIENCED DECREASED VISUAL ACUITY. A SLIT LAMP EXAMINATION SHOWED 3-4 CORNEAL EDEMA WITH THE PRESENCE OF HYPOPYON, BCDVA VISUAL ACUITY (VA) MEASUREMENTS WAS LIGHT PERCEPTION. THE PATIENT WAS REFERRED TO A RETINAL SPECIALIST. FOLLOW UP ONE WEEK POST-OP WITH A RETINAL SPECIALIST SHOWED SLIT LAMP EXAM INDICATES 2+ DESCEMET'S FOLDS, 4+ CELL, LESS THAN 1MM LAYERED HYPOPYON AND FIBRIN RETRACTING OVER PUPIL AND FIBRINOUS INFLAMMATION. THE PATIENT WAS DIAGNOSED WITH ENDOPHTHALMITIS IN THE RIGHT EYE. PATIENT WAS INJECTED WITH AN URGENT VITREOUS TAP OF VANCOMYCIN/CEFTAZIDIME. AFTER THE INJECTION THE PATIENTS VITREOUS TAP THE PATIENTS IOP SPIKED TO 84 MMHG. AN ANTERIOR CHAMBER TAP WAS PERFORMED AND THE IOP RETURNED TO 17 MMHG. THE PATIENT WAS INSTRUCTED TO START PRED ACETATE 1% EVERY HOUR AND ATROPINE TWICE A DAY. A B-SCAN WAS PERFORMED AND DUE TO DESCEMETS FOLDS AND HYPOPYON THERE WAS NO VIEW TO THE POSTERIOR POLE. PATIENT WAS INSTRUCTED TO USE TOPICAL PREDNISOLONE ACETATE 1% Q1H AND ATROPINE TWICE A DAY. THE FOLLOWING DAY THE PATIENT RETURNED TO THE RETINAL SPECIALIST. PATIENTS VA UVDVA WAS STABLE AT HAN
Patient problems: Blurred Vision; Corneal Edema; Endophthalmitis; Eye Pain; Hypopyon; Intraocular Pressure Increased
MAUDE report 21810212 ↗
Other Intraocular Lens devices
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- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens145 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens144 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens139 reports
- TECNIS SIMPLICITY DIB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens1 recall81 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens127 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens126 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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