enVista Envy IOLRecalls & reported problems across all models
Bausch & Lomb Incorporated · 53 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 Envy IOL model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 52
- Deaths reported
- 0
- Injuries reported
- 52
- Recalls
- 1
We found 53 models of enVista Envy IOL by Bausch & Lomb Incorporated in the FDA's device registry (GUDID). Together they are named in 52 adverse event reports in the FDA's MAUDE database, received between Mar 4, 2025 and Sep 30, 2026 — classified as 52 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (14 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 Envy 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-1680-2025 · Root cause: Process control · names 53 of these models · Recall details · FDA record ↗
Most reported enVista Envy IOL problems
Device problems
- Adverse Event Without Identified Device or Use Problem31
- Insufficient Device Problem Information14
- Manufacturing, Packaging or Shipping Problem5
- Device Dislodged or Dislocated1
- Material Integrity Problem1
- Material Opacification1
- Patient Device Interaction Problem1
- Wrong Label1
Patient problems
- Visual Disturbances24
- Toxic Anterior Segment Syndrome (TASS)15
- Halo14
- Visual Impairment13
- Hypopyon7
- Blurred Vision4
- Posterior Capsule Opacification4
- Insufficient Information3
enVista Envy IOL models
53 models, most reported first. Each model has its own page with its reports, recalls and device details.
- enVista Envy™ IOLLens, Multifocal Intraocular1 recall8 reports
- enVista Envy™ IOLLens, Multifocal Intraocular1 recall7 reports
- enVista Envy™ IOLLens, Multifocal Intraocular1 recall6 reports
- enVista Envy™ IOLLens, Multifocal Intraocular1 recall4 reports
- enVista Envy™ IOLLens, Multifocal Intraocular1 recall3 reports
- enVista Envy™ IOLLens, Multifocal Intraocular1 recall3 reports
- enVista Envy™ IOLLens, Multifocal Intraocular1 recall2 reports
- enVista Envy™ IOLLens, Multifocal Intraocular1 recall2 reports
- enVista Envy™ IOLLens, Multifocal Intraocular1 recall2 reports
- enVista Envy™ IOLLens, Multifocal Intraocular1 recall2 reports
- enVista Envy™ IOLLens, Multifocal Intraocular1 recall2 reports
- enVista Envy™ IOLLens, Multifocal Intraocular1 recall1 report
- enVista Envy™ IOLLens, Multifocal Intraocular1 recall1 report
- enVista Envy™ IOLLens, Multifocal Intraocular1 recall1 report
- enVista Envy™ IOLLens, Multifocal Intraocular1 recall1 report
- enVista Envy™ IOLLens, Multifocal Intraocular1 recall1 report
- enVista Envy™ IOLLens, Multifocal Intraocular1 recall1 report
- enVista Envy™ IOLLens, Multifocal Intraocular1 recall1 report
- enVista Envy™ IOLLens, Multifocal Intraocular1 recall1 report
- enVista Envy™ IOLLens, Multifocal Intraocular1 recall1 report
- enVista Envy™ IOLLens, Multifocal Intraocular1 recall1 report
- enVista Envy™ IOLLens, Multifocal Intraocular1 recall1 report
- enVista Envy™ IOLLens, Multifocal Intraocular1 recall0 reports
- enVista Envy™ IOLLens, Multifocal Intraocular1 recall0 reports
- enVista Envy™ IOLLens, Multifocal Intraocular1 recall0 reports
- enVista Envy™ IOLLens, Multifocal Intraocular1 recall0 reports
- enVista Envy™ IOLLens, Multifocal Intraocular1 recall0 reports
- enVista Envy™ IOLLens, Multifocal Intraocular1 recall0 reports
- enVista Envy™ IOLLens, Multifocal Intraocular1 recall0 reports
- enVista Envy™ IOLLens, Multifocal Intraocular1 recall0 reports
- enVista Envy™ IOLLens, Multifocal Intraocular1 recall0 reports
- enVista Envy™ IOLLens, Multifocal Intraocular1 recall0 reports
- enVista Envy™ IOLLens, Multifocal Intraocular1 recall0 reports
- enVista Envy™ IOLLens, Multifocal Intraocular1 recall0 reports
- enVista Envy™ IOLLens, Multifocal Intraocular1 recall0 reports
- enVista Envy™ IOLLens, Multifocal Intraocular1 recall0 reports
- enVista Envy™ IOLLens, Multifocal Intraocular1 recall0 reports
- enVista Envy™ IOLLens, Multifocal Intraocular1 recall0 reports
- enVista Envy™ IOLLens, Multifocal Intraocular1 recall0 reports
- enVista Envy™ IOLLens, Multifocal Intraocular1 recall0 reports
- enVista Envy™ IOLLens, Multifocal Intraocular1 recall0 reports
- enVista Envy™ IOLLens, Multifocal Intraocular1 recall0 reports
- enVista Envy™ IOLLens, Multifocal Intraocular1 recall0 reports
- enVista Envy™ IOLLens, Multifocal Intraocular1 recall0 reports
- enVista Envy™ IOLLens, Multifocal Intraocular1 recall0 reports
- enVista Envy™ IOLLens, Multifocal Intraocular1 recall0 reports
- enVista Envy™ IOLLens, Multifocal Intraocular1 recall0 reports
- enVista Envy™ IOLLens, Multifocal Intraocular1 recall0 reports
- enVista Envy™ IOLLens, Multifocal Intraocular1 recall0 reports
- enVista Envy™ IOLLens, Multifocal Intraocular1 recall0 reports
- enVista Envy™ IOLLens, Multifocal Intraocular1 recall0 reports
- enVista Envy™ IOLLens, Multifocal Intraocular1 recall0 reports
- enVista Envy™ IOLLens, Multifocal Intraocular1 recall0 reports
Recent enVista Envy IOL adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that approximately four months post intraocular lens (IOL) implantation in the right eye, the lens was explanted due to the patient experiencing glares and halos. A back up lens of a different model was placed.
Patient problems: Halo; Visual Disturbances
MAUDE report 50944761 ↗InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem
It was reported that approximately five months after implantation of an intraocular lens (IOL) in the right eye (OD), the IOL was exchanged with a different model lens due to unresolved dysphotopsia and mechanical complication of the IOL. Additional information was requested but not received.
Patient problems: Visual Disturbances
MAUDE report 50867405 ↗InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem
It was reported approximately 4 months after a multifocal IOL was placed in the patients Left eye (OS) the lens was explanted and replaced with a monofocal IOL due to the patient reporting difficulty while driving at night due to circles in visual field while driving at night. Additional information regarding this event was requested but never received.
Patient problems: Visual Disturbances
MAUDE report 50691674 ↗InjuryAug 26, 2026Adverse Event Without Identified Device or Use Problem
It was reported approximately 10 weeks after implantation of a Multifocal intraocular lens (IOL) into the patients left eye (OS) the IOL was exchanged for a monofocal lens due to the patient having intolerable dysphotopsia with the multifocal lens. Per the reporter the dysphotopsia was resolved with the lens exchange.
Patient problems: Visual Disturbances
MAUDE report 50458838 ↗InjuryAug 25, 2026Adverse Event Without Identified Device or Use Problem
It was reported that approximately six months after implantation of an intraocular lens (IOL) in the patient's dominant right eye (OD), the lens was exchanged with a different model due to persistent halos experienced during both daytime and nighttime conditions. Prior to the lens exchange, the surgeon attempted to manage the symptoms by treating the patient's dry eye; however, the halos remained unresolved. In the surgeon's opinion, the most likely cause of the event was the patient's visual system/brain inability to tolerate halo phenomena associated with multifocal IOLs, noting that such symptoms can occur with all multifocal lenses. Additional information was requested but not received.
Patient problems: Halo
MAUDE report 50438925 ↗InjuryAug 25, 2026Adverse Event Without Identified Device or Use Problem
It was reported that approximately 9 months after implantation of an intraocular lens (IOL) in the right eye (OD), the lens was explanted.This report is for the right eye (OD). Left eye (OS) reference: 0001313525-2026-00124.
Patient problems: Insufficient Information
MAUDE report 50429030 ↗InjuryAug 25, 2026Adverse Event Without Identified Device or Use Problem
It was reported that approximately 9 months after implantation of an intraocular lens (IOL) in the left eye (OS), the lens was explanted.This report is for the left eye (OS). Right eye (OD) reference: (b)(4).
Patient problems: Insufficient Information
MAUDE report 50428792 ↗InjuryAug 21, 2026Wrong Label
It was reported that after implantation of an intraocular lens (IOL) in the right eye (OD), the refractive outcome revealed an approximately 3.0 diopter refractive miss. The IOL power calculations were reviewed and confirmed to be accurate, indicating that the patient should have achieved the intended refractive outcome. Based on these findings, the surgeon suspected that the implanted IOL may have been mislabeled and elected to perform an IOL exchange using the same model and diopter power approximately 6 weeks after the initial procedure. Patient outcome is good. In the surgeon's opinion, the most likely cause of the event is the initial IOL was mislabeled.
Patient problems: Visual Impairment
MAUDE report 50376656 ↗InjuryJul 21, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED EIGHT DAYS AFTER A MULTIFOCAL LENS (IOL) WAS PLACED IN THE PATIENTS LEFT EYE (OS) THE PATIENT FELT THEIR QUALITY OF VISION AND COLOR VISION WAS POOR. APPROXIMATELY NINE WEEKS AFTER THE LENS WAS INITIALLY PLACED IT WAS EXPLANTED AND REPLACED FOR A DIFFERENT MODEL LENS. THE SURGEON CITES PATIENT DISSATISFACTION AS THE ISSUE WITH A GOOD POST EXCHANGE OUTCOME.
Patient problems: Visual Disturbances
MAUDE report 25898719 ↗InjuryJul 16, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT APPROXIMATELY 7 MONTHS AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) IN THE RIGHT EYE (OD), THE IOL WAS EXCHANGED FOR A DIFFERENT MODEL LENS DUE UNRESOLVED GLARE AND HALOS. IN THE SURGEON'S OPINION, THE MOST LIKELY CAUSE OF THE EVENT WAS THE PATIENT'S INABILITY TO NEUROADAPT TO THE TRIFOCAL IOL. PATIENT OUTCOME IS GOOD, AND THE PATIENT IS EXPERIENCING LESS DYSPHOTOPSIA WITH THE REPLACEMENT IOL. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED.
Patient problems: Halo; Visual Disturbances
MAUDE report 25846408 ↗InjuryJun 24, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT APPROXIMATELY TWO WEEKS AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) IN THE PATIENT'S RIGHT EYE (OD), THE PATIENT COMPLAINED OF VISUAL DISTURBANCES INCLUDING DOUBLING AND SHADOWING OF LETTERS AND LIGHTS, LIGHT RELATED GLARE AND HALOS, AND GHOSTING OF OBJECTS SUCH AS CARS. APPROXIMATELY THREE MONTHS AFTER SYMPTOM ONSET, THE IOL WAS EXCHANGED FOR A DIFFERENT MODEL. IN THE SURGEON¿S OPINION, THE MOST LIKELY CAUSE OF EVENT WAS VISUAL DISTURBANCE WITH THE MULTIFOCAL IOL. THE PATIENT HAS SINCE RECOVERED. THIS IS THE REPORT FOR THE RIGHT EYE (OD). LEFT EYE (OS) REFERENCE: 0001313525-2026-00087.
Patient problems: Diplopia/Double Vision; Halo; Photophobia; Visual Disturbances
MAUDE report 25612500 ↗InjuryJun 24, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT APPROXIMATELY TWO WEEKS AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) IN THE PATIENT¿S LEFT EYE (OS), THE PATIENT COMPLAINED OF VISUAL DISTURBANCES INCLUDING DOUBLING AND SHADOWING OF LETTERS AND LIGHTS, LIGHT RELATED GLARE AND HALOS, AND GHOSTING OF OBJECTS SUCH AS CARS. APPROXIMATELY THREE MONTHS AFTER SYMPTOM ONSET, THE IOL WAS EXCHANGED FOR A DIFFERENT MODEL. IN THE SURGEON¿S OPINION, THE MOST LIKELY CAUSE OF EVENT WAS VISUAL DISTURBANCE WITH THE MULTIFOCAL IOL. THE PATIENT HAS SINCE RECOVERED. THIS IS THE REPORT FOR THE LEFT EYE (OS). RIGHT EYE (OD) REFERENCE: 0001313525-2026-00088.
Patient problems: Diplopia/Double Vision; Halo; Photophobia; Visual Disturbances
MAUDE report 25612183 ↗InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT FOUR DAYS POST INTRAOCULAR LENS (IOL) IMPLANTATION IN THE RIGHT EYE, THE PATIENT REPORTED EXPERIENCING FOREIGN BODY SENSATION, VISUAL DISTURBANCES SUCH AS SHADOWS IN PERIPHERY WITH SEVERE GLARE AND HALOS AT NIGHT AND FEELING IMBALANCED. AFTER ONE MONTH OF DRY EYE TREATMENT THE PATIENT DID NOT IMPROVE; THEREFORE THE LENS WAS EXPLANTED. AN IOL OF A DIFFERENT MODEL WAS IMPLANTED AND THE PATIENTS CURRENT PROGNOSIS IS REPORTED TO BE GOOD.
Patient problems: Foreign Body Sensation in Eye; Halo; Visual Disturbances
MAUDE report 25442652 ↗InjuryJun 3, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT 9 DAYS AFTER THE IMPLANTATION OF A MULTIFOCAL INTRAOCULAR LENS (IOL) INTO THE RIGHT EYE (OD) THE PATIENT COMPLAINED OF HALOS AND BLURRY VISION. ABOUT THREE AND A HALF MONTHS AFTER SYMPTOM ONSET, THE INITIAL IOL WAS REMOVED AND REPLACED WITH A DIFFERENT MODEL LENS. IN THE SURGEON'S OPINION, THE MOST LIKELY CAUSE OF THE EVENT WAS IOL COMPLICATIONS SPECIFICALLY GLARE AND HALOS. THE SURGEON REPORTS A SUCCESSFUL POST EXCHANGE OUTCOME.
Patient problems: Blurred Vision; Halo
MAUDE report 25377876 ↗InjuryJun 3, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) IN THE RIGHT EYE (OD), THE PATIENT EXPERIENCED HALOS, REDUCED CONTRAST SENSITIVITY AND DIMINISHED COLOR VISION. THE PATIENT WAS TREATED WITH ARTIFICIAL TEARS, STEROID EYE DROPS, AND UNDERWENT A DIAGNOSTIC BRAIN MRI. DESPITE THESE INTERVENTIONS, THE PATIENT REQUESTED AN IOL EXCHANGE. APPROXIMATELY SEVEN MONTHS AFTER IMPLANTATION, THE IOL WAS EXCHANGED FOR A DIFFERENT MODEL LENS. IN THE SURGEON'S OPINION, THE MOST LIKELY CAUSE OF THE EVENT WAS MULTIFOCAL LENS INTOLERANCE. THE PATIENT'S OUTCOME IS GOOD.
Patient problems: Halo; Visual Disturbances
MAUDE report 25375090 ↗
Other Bausch & Lomb Incorporated products
- enVista IOL74 models · 70 reports · 1 recall
- enVista Toric IOL450 models · 15 reports · 2 recalls
- 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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