enVista Aspire Toric IOLRecalls & reported problems across all models
Bausch & Lomb Incorporated · 513 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names at least one enVista Aspire Toric IOL model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls
- 1
We found 513 models of enVista Aspire Toric IOL by Bausch & Lomb Incorporated in the FDA's device registry (GUDID). Together they are named in 8 adverse event reports in the FDA's MAUDE database, received between Jul 17, 2024 and Jun 9, 2026 — classified as 8 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (6 reports).
1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
enVista Aspire Toric IOL recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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 · names 513 of these models · Recall details · FDA record ↗
Most reported enVista Aspire Toric IOL problems
Device problems
- Insufficient Device Problem Information6
- Adverse Event Without Identified Device or Use Problem3
Patient problems
- Eye Pain3
- Insufficient Information3
- Intraocular Pressure Increased3
- Hypopyon2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Blurred Vision1
- Capsular Bag Tear1
- Corneal Edema1
enVista Aspire Toric IOL models
513 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- enVista Aspire™ Toric IOL ETAIntraocular Lens1 recall1 report
- enVista Aspire™ Toric IOL ETAIntraocular Lens1 recall1 report
- enVista Aspire™ Toric IOL ETAIntraocular Lens1 recall1 report
- enVista Aspire™ Toric IOL ETAIntraocular Lens1 recall1 report
- enVista Aspire™ Toric IOL ETAIntraocular Lens1 recall1 report
- enVista Aspire™ Toric IOL ETAIntraocular Lens1 recall1 report
- enVista Aspire™ Toric IOL ETAIntraocular Lens1 recall1 report
- enVista Aspire™ Toric IOL ETAIntraocular Lens1 recall1 report
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- enVista Aspire™ Toric IOL ETAIntraocular Lens1 recall0 reports
- enVista Aspire™ Toric IOL ETAIntraocular Lens1 recall0 reports
- enVista Aspire™ Toric IOL ETAIntraocular Lens1 recall0 reports
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- enVista Aspire™ Toric IOL ETAIntraocular Lens1 recall0 reports
- enVista Aspire™ Toric IOL ETAIntraocular Lens1 recall0 reports
- enVista Aspire™ Toric IOL ETAIntraocular Lens1 recall0 reports
- enVista Aspire™ Toric IOL ETAIntraocular Lens1 recall0 reports
- enVista Aspire™ Toric IOL ETAIntraocular Lens1 recall0 reports
- enVista Aspire™ Toric IOL ETAIntraocular Lens1 recall0 reports
- enVista Aspire™ Toric IOL ETAIntraocular Lens1 recall0 reports
- enVista Aspire™ Toric IOL ETAIntraocular Lens1 recall0 reports
- enVista Aspire™ Toric IOL ETAIntraocular Lens1 recall0 reports
- enVista Aspire™ Toric IOL ETAIntraocular Lens1 recall0 reports
- enVista Aspire™ Toric IOL ETAIntraocular Lens1 recall0 reports
- enVista Aspire™ Toric IOL ETAIntraocular Lens1 recall0 reports
- enVista Aspire™ Toric IOL ETAIntraocular Lens1 recall0 reports
- enVista Aspire™ Toric IOL ETAIntraocular Lens1 recall0 reports
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- enVista Aspire™ Toric IOL ETAIntraocular Lens1 recall0 reports
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Recent enVista Aspire Toric IOL adverse event reports
The 8 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) IN THE RIGHT EYE (OD), THE SURGEON DETERMINED THAT A VITRECTOMY WAS REQUIRED AFTER THE INITIAL LENS WAS PLACED. THE IOL WAS REMOVED, A VITRECTOMY WAS PERFORMED, AND A BACKUP LENS WAS SUBSEQUENTLY IMPLANTED. THE PATIENT'S POSTOPERATIVE OUTCOME IS EXPECTED TO BE GOOD. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED.
Patient problems: Insufficient Information
MAUDE report 25442745 ↗InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem
A CAPSULAR DAMAGE INVOLVING AN ENVISTA IOL WAS REPORTED. IT IS UNCLEAR IF THE CAPSULE DAMAGE HAPPENED DURING PHACO, LENS IMPLANT, OR LENS ROTATION. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED.
Patient problems: Capsular Bag Tear
MAUDE report 25045459 ↗InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENTS EYE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT RECEIVED.
Patient problems: Insufficient Information
MAUDE report 23846277 ↗InjuryDec 3, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORT THAT 1-DAY AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE EYE, THE PATIENT PRESENTED WITH HIGH INTRAOCULAR PRESSURE (IOP) AND HAD PAIN. AN ANTERIOR CHAMBER TAP WAS PERFORMED, THE PRESSURE CAME DOWN THE FOLLOWING DAY, AND THE PATIENT HAS NOT REPORTED ANY SYMPTOMS POST-TREATMENT. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED. THIS IS LENS #1 OF 2 FOR THIS PATIENT. REF: (B)(4).
Patient problems: Eye Pain; Intraocular Pressure Increased
MAUDE report 23708680 ↗InjuryDec 3, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORT THAT 1-DAY AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE EYE, THE PATIENT PRESENTED WITH HIGH INTRAOCULAR PRESSURE (IOP) AND HAD PAIN. AN ANTERIOR CHAMBER TAP WAS PERFORMED, THE PRESSURE CAME DOWN THE FOLLOWING DAY, AND THE PATIENT HAS NOT REPORTED ANY SYMPTOMS POST-TREATMENT. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED. THIS IS LENS #2 OF 2 FOR THIS PATIENT. REF: (B)(4).
Patient problems: Eye Pain; Intraocular Pressure Increased
MAUDE report 23708637 ↗InjuryJun 11, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT 1 DAY AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE LEFT EYE (OS), THE PATIENT PRESENTED WITH MODERATE WOUND EDEMA, 4+ CELL, FIBRIN & HYPOPYON. BASED ON THE FINDINGS, THE SURGEON CONCLUDED THE CAUSE AS TOXIC ANTERIOR SEGMENT SYNDROME (TASS). AS A PRECAUTION, THE PATIENT WAS IMMEDIATELY REFERRED TO RETINA FOR A CULTURE TO BE PERFORMED AND INTRAVITREAL INJECTIONS OF VANCOMYCIN & CEFTAZIDIME TO BE ADMINISTERED. THE FOLLOWING DAY THE PATIENT HAD AN ADDITIONAL ROUND OF INTRAVITREAL INJECTIONS OF VANCOMYCIN & CEFTAZIDIME. THERE WAS NO GROWTH FROM THE CULTURE. THE INFLAMMATION/TASS HAS FULLY RESOLVED. IN THE SURGEON'S OPINION, THE MOST LIKELY CAUSE OF THE EVENT IS THE LENS. ACCORDING TO THE SURGEON, PATIENT OUTCOME IS GOOD. ACCORDING TO THE CONSUMER, HER DISTANCE VISION IS BLURRY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hypopyon; Toxic Anterior Segment Syndrome (TASS); Visual Disturbances; Visual Impairment
MAUDE report 22187346 ↗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 ↗InjuryJul 17, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT TWO WEEKS AFTER THE IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE LEFT EYE, THE IOL WAS EXCHANGED DUE TO UNSPECIFIED MECHANICAL COMPLICATION OF THE IOL. THE REPLACEMENT IOL WAS THE SAME MODEL, WITH 0.5D DIFFERENCE FROM THE INITIAL IOL. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT RECEIVED.
Patient problems: Insufficient Information
MAUDE report 19761612 ↗
Other Bausch & Lomb Incorporated products
- enVista IOL74 models · 70 reports · 1 recall
- enVista Toric IOL450 models · 15 reports · 2 recalls
- enVista Envy IOL53 models · 52 reports · 1 recall
- enVista Envy Toric IOL513 models · 39 reports · 1 recall
- enVista Aspire IOL57 models · 10 reports · 1 recall
- Akreos IOL8 models · 10 reports · 1 recall
- IC-8 Apthera IOL20 models · 38 reports
- SofPort IOL20 models · 29 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- 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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