enVista Toric IOLRecalls & reported problems across all models
Bausch & Lomb Incorporated · 450 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one enVista Toric IOL model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 15
- Recalls
- 2
We found 450 models of enVista Toric IOL by Bausch & Lomb Incorporated in the FDA's device registry (GUDID). Together they are named in 15 adverse event reports in the FDA's MAUDE database, received between May 12, 2023 and Sep 29, 2026 — classified as 15 injuries.
The most frequently reported specific device problem is “Unintended Movement” (5 reports).
2 FDA recall records 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 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, 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-1679-2025 · Root cause: Process control · names 441 of these models · Recall details · FDA record ↗
- Jun 9, 2020Terminated
The toric axis marks were misaligned (from the expected position in relation to the haptics) on an implanted lens.
Z-2552-2020 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗
Most reported enVista Toric IOL problems
Device problems
- Adverse Event Without Identified Device or Use Problem6
- Unintended Movement5
- Insufficient Device Problem Information3
- Break1
- Device Dislodged or Dislocated1
Patient problems
- Blurred Vision5
- Visual Disturbances4
- Visual Impairment4
- Insufficient Information3
- Toxic Anterior Segment Syndrome (TASS)3
- Hypopyon2
- Endophthalmitis1
- Excessive Tear Production1
enVista Toric IOL models
450 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- enVista® Toric IOL MX60ETintraocular lens1 recall1 report
- enVista® Toric IOL ETEintraocular lens1 recall1 report
- enVista® Toric IOL ETEintraocular lens1 recall1 report
- enVista® Toric IOL ETEintraocular lens1 recall1 report
- enVista® Toric IOL ETEintraocular lens1 recall1 report
- enVista® Toric IOL ETEintraocular lens1 recall1 report
- enVista® Toric IOL ETEintraocular lens1 recall1 report
- enVista® Toric IOL ETEintraocular lens1 recall0 reports
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- enVista® Toric IOL ETEintraocular lens1 recall0 reports
- enVista® Toric IOL ETEintraocular lens1 recall0 reports
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- enVista® Toric IOL ETEintraocular lens1 recall0 reports
- enVista® Toric IOL ETEintraocular lens1 recall0 reports
- enVista® Toric IOL ETEintraocular lens1 recall0 reports
- enVista® Toric IOL ETEintraocular lens1 recall0 reports
- enVista® Toric IOL ETEintraocular lens1 recall0 reports
- enVista® Toric IOL ETEintraocular lens1 recall0 reports
- enVista® Toric IOL ETEintraocular lens1 recall0 reports
- enVista® Toric IOL ETEintraocular lens1 recall0 reports
- enVista® Toric IOL ETEintraocular lens1 recall0 reports
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Recent enVista Toric IOL adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Insufficient Device Problem Information
It was reported that approximately five weeks after implantation of an intraocular lens (IOL), the patient presented with fibrin and hypopyon in the anterior chamber. Visual acuity decreased to count fingers at 20 feet. Based on the clinical findings the surgeon concluded the cause as Toxic Anterior Segment Syndrome (TASS). A Tap procedure was performed, and a corticosteroid injection was administered. Due to the severity of the inflammation, oral corticosteroid therapy was initiated. The patient's condition subsequently improved; however, vision remains significantly reduced. Additional information was requested but was not received.
Patient problems: Hypopyon; Toxic Anterior Segment Syndrome (TASS); Visual Impairment
MAUDE report 50931606 ↗InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem
It was reported following left eye intraocular lens (IOL) implantation, the patient experienced glare. Approximately three months later, the implanted IOL was explanted and replaced with a different model lens of a different power. The patient subsequently recovered.
Patient problems: Visual Disturbances
MAUDE report 50854959 ↗InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT'S LEFT EYE DUE TO PERSISTENT BLURRY VISION AND DISCOMFORT OF THE LENS. A NEW IOL OF A DIFFERENT LENS MODEL AND POWER WAS IMPLANTED SUCCESSFULLY WITH NO COMPLICATIONS. THE SURGEON ATTRIBUTES THE LIKELY CAUSE OF THE EVENT TO DYSPHOTOPSIA.
Patient problems: Eye Pain; Visual Disturbances
MAUDE report 23827606 ↗InjuryJul 10, 2025Unintended Movement; Unintended Movement
IT WAS REPORTED THAT APPROXIMATIVELY 2 MONTHS AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE RIGHT EYE (OD), THE LENS WAS EXCHANGED WITH A DIFFERENT DIOPTER OF THE SAME MODEL LENS DUE TO THE INITIAL LENS BEING THE WRONG POWER AND ROTATING OUT OF POSITION. IN THE SURGEON'S OPINION, THE MOST LIKELY CAUSE OF THE EVENT IS THAT THE LENS SHIFTED AND CHANGED AXIS OF THE LENS. FOUR DAYS POST EXCHANGE, IT WAS REPORTED THE PATIENT¿S VISION WAS STILL BLURRY. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT RECEIVED.
Patient problems: Blurred Vision
MAUDE report 22470387 ↗InjuryJun 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A SURGICAL CENTER REPORTED THAT 3 DAYS AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE LEFT EYE, THE PATIENT EXPERIENCED DYSPHOTOPSIA. APPROXIMATELY FIVE MONTHS AFTER IMPLANTATION, THE IOL WAS EXCHANGED WITH A DIFFERENT MODEL IOL.
Patient problems: Visual Disturbances
MAUDE report 22333601 ↗InjuryJun 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A SURGICAL CENTER REPORTED THAT 3 DAYS AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE RIGHT EYE, THE PATIENT EXPERIENCED DYSPHOTOPSIA. APPROXIMATELY FIVE MONTHS AFTER IMPLANTATION, THE IOL WAS EXCHANGED WITH A DIFFERENT MODEL IOL.
Patient problems: Visual Disturbances
MAUDE report 22333580 ↗InjuryMay 1, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT LESS THAN 24 HOURS AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE LEFT EYE, THE PATIENT PRESENTED WITH DECREASED VISION, ANTERIOR CHAMBER FIBRIN/INFLAMMATION, AND HYPOPYON. THE PATIENT WAS TREATED WITH TOBRAMYCIN 0.3% 1 DROP 4 TIMES A DAY FOR 1 WEEK, PROLENSA 0.07% 1 DROP 4 TIMES A DAY FOR 1 MONTH, DEXTENZA, CIPROFLOXIN 0.3% 2 DROPS 6 TIMES A DAY AND DUREZOL 0.05% 6 TIMES A DAY. BASED ON THE FINDINGS THE SURGEON CONCLUDED THE CAUSE AS TOXIC ANTERIOR SEGMENT SYNDROME (TASS). IN THE SURGEON¿S OPINION, THE MOST LIKELY CAUSE OF THE EVENT IS TASS. PATIENT OUTCOME IS UNCERTAIN.
Patient problems: Hypopyon; Toxic Anterior Segment Syndrome (TASS); Visual Impairment
MAUDE report 21944442 ↗InjuryApr 23, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT ONE DAY AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE RIGHT EYE, THE PATIENT PRESENTED WITH DECREASED VISUAL ACUITY AND INCREASED IOP (PRE OP 17 MMHG AND POST OP IS 25 MMHG). BASED ON THE FINDINGS THE SURGEON CONCLUDED THE CAUSE AS TOXIC ANTERIOR SEGMENT SYNDROME (TASS) AND POSSIBLE ENDOPHTHALMITIS. THE PATIENT WAS TREATED WITH ATROPINE, PRED, AND AN INJECTION OF VANCO AND CEFAZIDIME. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED.
Patient problems: Endophthalmitis; Intraocular Pressure Increased; Toxic Anterior Segment Syndrome (TASS); Visual Impairment
MAUDE report 21896629 ↗InjurySep 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT APPROXIMATELY 11 WEEKS AFTER THE IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE LEFT EYE, THE LENS WAS EXCHANGED WITH A DIFFERENT DIOPTER IOL. ALLEGEDLY, THE PATIENT COULD NOT ADAPT TO THE INITIAL IOL. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT RECEIVED.
Patient problems: Insufficient Information; Unspecified Eye / Vision Problem
MAUDE report 20263668 ↗InjuryMay 8, 2024Unintended Movement; Unintended Movement
IT WAS REPORTED THAT THE DAY AFTER THE IMPLANTATION OF AN INTRAOCULAR LENS (IOL), INTO THE RIGHT EYE, THE LENS ROTATED OUT OF POSITION. SUBSEQUENTLY, THE PATIENT BEGAN TO EXPERIENCE A DECREASE IN VISION. APPROXIMATELY 2 MONTHS POST-OP, THE LENS WAS EXCHANGED WITH A DIFFERENT MODEL IOL. THE PATIENT IS REPORTED TO BE DOING WELL.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 19273426 ↗InjuryJan 25, 2024Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated
IT WAS REPORTED THAT AFTER THE INSERTION OF AN IOL, INTO THE EYE, A PORTION OF THE IOL HAPTIC/OPTIC JUNCTION WAS BROKEN. THE SURGEON MADE THE DECISION TO LEAVE THE IOL IN THE EYE, BECAUSE IT SEEMED STABLE. APPROXIMATELY A WEEK AFTER THE IMPLANTATION, THERE WAS A FORTY-DEGREE ROTATION OF THE IOL. THE IOL WAS EXPLANTED AND REPLACED WITH A LENS OF THE SAME MODEL AND DIOPTER, 2 WEEKS POST-IMPLANTATION. IN THE SURGEON''S OPINION, THE PARTIALLY BROKEN OPTIC/HAPTIC JUNCTION MAY HAVE CAUSED THE IOL ROTATION. THE PATIENT OUTCOME IS GOOD.
Patient problems: Insufficient Information
MAUDE report 18584208 ↗InjuryJan 11, 2024Unintended Movement; Unintended Movement
IT WAS REPORTED THAT APPROXIMATELY FIVE AND A HALF MONTHS AFTER IMPLANTATION OF AN INTRAOCULAR LENS INTO THE RIGHT EYE (OD), THE LENS ROTATED OUT OF POSITION. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT RECEIVED.
Patient problems: Insufficient Information
MAUDE report 18493876 ↗InjuryJun 15, 2023Unintended Movement; Unintended Movement
IT WAS REPORTED APPROXIMATELY TWO WEEKS AFTER IMPLANTATION OF AN INTRAOCULAR LENS INTO THE LEFT EYE (OS) THE LENS ROTATED OUT OF POSITION. LENS ROTATION WAS SCHEDULED FOR APPROXIMATELY SEVEN WEEKS AFTER INITIAL SURGERY. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT RECEIVED.
Patient problems: Blurred Vision
MAUDE report 17137583 ↗InjuryMay 31, 2023Unintended Movement; Unintended Movement
IT WAS REPORTED ONE DAY AFTER IMPLANTATION OF AN INTRAOCULAR LENS INTO THE LEFT EYE (OS) THE LENS ROTATED OUT OF POSITION. APPROXIMATELY ONE-MONTH POST-OP, THE IOL WAS REPOSITIONED TO ITS INTENDED POSITION. IN THE SURGEON''S OPINION, THE CAUSE OF THE IOL ROTATION IS UNKNOWN. PATIENT OUTCOME IS GOOD.
Patient problems: Blurred Vision
MAUDE report 17032574 ↗InjuryMay 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION WAS RECEIVED INDICATING AN UNVALIDATED INJECTOR WAS USED TO COMPLETE THIS SURGERY. ALSO THE OUTCOME ACCORDING TO THE SURGEON WAS SUBJECTIVE AND THERE WAS NO ISSUES REPORTED WITH THE LENS. IT IS NOTEWORTHY TO MENTION THAT THE REPLACEMENT IOL WAS OF A DIFFERENT MODEL AND DIOPTER.
Patient problems: Blurred Vision; Excessive Tear Production; Halo
MAUDE report 16918739 ↗
Other Bausch & Lomb Incorporated products
- enVista IOL74 models · 70 reports · 1 recall
- enVista Envy IOL53 models · 52 reports · 1 recall
- enVista Envy Toric IOL513 models · 39 reports · 1 recall
- Akreos IOL8 models · 10 reports · 1 recall
- enVista Aspire IOL57 models · 10 reports · 1 recall
- enVista Aspire Toric IOL513 models · 8 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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