enVista IOLRecalls & reported problems across all models
Bausch & Lomb Incorporated · 74 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 IOL model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 70
- Deaths reported
- 0
- Injuries reported
- 70
- Recalls
- 1
We found 74 models of enVista IOL by Bausch & Lomb Incorporated in the FDA's device registry (GUDID). Together they are named in 70 adverse event reports in the FDA's MAUDE database, received between Feb 23, 2023 and Sep 16, 2026 — classified as 70 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (33 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 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 55 of these models · Recall details · FDA record ↗
Most reported enVista IOL problems
Device problems
- Insufficient Device Problem Information33
- Adverse Event Without Identified Device or Use Problem27
- Manufacturing, Packaging or Shipping Problem6
- Break3
- Crack2
- Device Dislodged or Dislocated2
- Material Opacification2
- Material Twisted/Bent1
Patient problems
- Toxic Anterior Segment Syndrome (TASS)32
- Visual Impairment20
- Hypopyon14
- Visual Disturbances14
- Corneal Edema12
- Insufficient Information8
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available6
- Intraocular Pressure Increased6
enVista IOL models
74 models, most reported first. Each model has its own page with its reports, recalls and device details.
- enVista® IOL EEintraocular lens1 recall7 reports
- enVista® IOL EEintraocular lens1 recall5 reports
- enVista® IOL EEintraocular lens1 recall3 reports
- enVista® IOL EEintraocular lens1 recall3 reports
- enVista® IOL EEintraocular lens1 recall3 reports
- enVista® IOL EEintraocular lens1 recall2 reports
- enVista® IOL EEintraocular lens1 recall1 report
- enVista® IOL EEintraocular lens1 recall1 report
- enVista® IOL EEintraocular lens1 recall1 report
- enVista® IOL EEintraocular lens1 recall1 report
- enVista® IOL EEintraocular lens1 recall1 report
- enVista® IOL EEintraocular lens1 recall1 report
- enVista® IOL EEintraocular lens1 recall1 report
- enVista® IOL EEintraocular lens1 recall1 report
- enVista® IOL EEintraocular lens1 recall1 report
- enVista® IOL EEintraocular lens1 recall1 report
- enVista® IOL EEintraocular lens1 recall1 report
- enVista® IOL EEintraocular lens1 recall0 reports
- enVista® IOL EEintraocular lens1 recall0 reports
- enVista® IOL EEintraocular lens1 recall0 reports
- enVista® IOL EEintraocular lens1 recall0 reports
- enVista® IOL EEintraocular lens1 recall0 reports
- enVista® IOL EEintraocular lens1 recall0 reports
- enVista® IOL EEintraocular lens1 recall0 reports
- enVista® IOL EEintraocular lens1 recall0 reports
- enVista® IOL EEintraocular lens1 recall0 reports
- enVista® IOL EEintraocular lens1 recall0 reports
- enVista® IOL EEintraocular lens1 recall0 reports
- enVista® IOL EEintraocular lens1 recall0 reports
- enVista® IOL EEintraocular lens1 recall0 reports
- enVista® IOL EEintraocular lens1 recall0 reports
- enVista® IOL EEintraocular lens1 recall0 reports
- enVista® IOL EEintraocular lens1 recall0 reports
- enVista® IOL EEintraocular lens1 recall0 reports
- enVista® IOL EEintraocular lens1 recall0 reports
- enVista® IOL EEintraocular lens1 recall0 reports
- enVista® IOL EEintraocular lens1 recall0 reports
- enVista® IOL EEintraocular lens1 recall0 reports
- enVista® IOL EEintraocular lens1 recall0 reports
- enVista® IOL EEintraocular lens1 recall0 reports
- enVista® IOL EEintraocular lens1 recall0 reports
- enVista® IOL EEintraocular lens1 recall0 reports
- enVista® IOL EEintraocular lens1 recall0 reports
- enVista® IOL EEintraocular lens1 recall0 reports
- enVista® IOL EEintraocular lens1 recall0 reports
- enVista® IOL EEintraocular lens1 recall0 reports
- enVista® IOL EEintraocular lens1 recall0 reports
- enVista® IOL EEintraocular lens1 recall0 reports
- enVista® IOL EEintraocular lens1 recall0 reports
- enVista® IOL EEintraocular lens1 recall0 reports
- enVista® IOL EEintraocular lens1 recall0 reports
- enVista® IOL EEintraocular lens1 recall0 reports
- enVista® IOL EEintraocular lens1 recall0 reports
- enVista® IOL EEintraocular lens1 recall0 reports
- enVista® IOL EEintraocular lens1 recall0 reports
- enVista® IOL MX60Eintraocular lens4 reports
- enVista® IOL MX60Eintraocular lens4 reports
- enVista® IOL MX60Eintraocular lens4 reports
- enVista® IOL MX60Eintraocular lens3 reports
- enVista® IOL MX60Eintraocular lens3 reports
- enVista® IOL MX60Eintraocular lens2 reports
- enVista® IOL MX60Eintraocular lens2 reports
- enVista® IOL MX60Eintraocular lens2 reports
- enVista® IOL MX60Eintraocular lens2 reports
- enVista® IOL MX60Eintraocular lens1 report
- enVista® IOL MX60Eintraocular lens1 report
- enVista® IOL MX60Eintraocular lens1 report
- enVista® IOL MX60Eintraocular lens1 report
- enVista® IOL MX60Eintraocular lens1 report
- enVista® IOL MX60Eintraocular lens1 report
- enVista® IOL MX60PLintraocular lens1 report
- enVista® IOL MX60PLintraocular lens1 report
- enVista® IOL MX60PLintraocular lens1 report
- enVista® IOL MX60PLintraocular lens1 report
Recent enVista IOL adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 16, 2026Wrong Label
Patient problems: Insufficient Information
MAUDE report 50794612 ↗InjuryJun 18, 2026Crack
IT WAS REPORTED THAT UPON IMPLANTATION OF AN INTRAOCULAR LENS (IOL) IN THE EYE, THE SURGEON OBSERVED A CRACK AT THE OPTIC-HAPTIC JUNCTION. THE INCISION WAS ENLARGED, THE DAMAGED IOL WAS REMOVED, AND A REPLACEMENT LENS WAS IMPLANTED. ACCORDING TO THE SURGEON, THE PATIENT EXPERIENCED SIGNIFICANT POSTOPERATIVE CORNEAL EDEMA, WHICH WAS ATTRIBUTED TO THE EXTENDED SURGICAL TIME AND ADDITIONAL TISSUE MANIPULATION REQUIRED FOR LENS REMOVAL AND REPLACEMENT. IN THE SURGEON'S OPINION, THE MOST LIKE CAUSE OF THE EVENT WAS THE LENS ITSELF, NOTING THAT THE TECHNICIAN DID NOT NOTICE ANY ISSUES DURING LENS LOADING. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED.
Patient problems: Corneal Edema
MAUDE report 25553427 ↗InjuryJun 18, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT 11 DAYS AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) IN THE RIGHT EYE (OD), THE PATIENT PRESENTED WITH CLINICAL FINDINGS CONSISTENT WITH ENDOPHTHALMITIS. AT THAT TIME, VISUAL ACUITY HAD DECREASED FROM 20/200 TO HAND MOTION. THE PATIENT WAS REFERRED THE SAME DAY TO A RETINA SPECIALIST, WHO DOCUMENTED 1-2 ANTERIOR CHAMBER CELLS, <1MM HYPOPYON, FIBRINOID MEMBRANE AT PUPIL, POSTERIOR SYNECHIAE, AND DENSE VITREOUS OPACITIES. A VITREOUS TAP WAS PERFORMED, AND INTRAVITREAL VANCOMYCIN AND CEFTAZIDIME WAS ADMINISTERED. THE CULTURE SHOWED NO GROWTH. IN THE IMPLANTING SURGEON'S OPINION, THE MOST LIKELY CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE FOLLOWING MEDICATIONS WERE PRESCRIBED FOR USE AT HOME POST-OPERATIVELY: PREDNISOLONE 1%: 1 GTT QID X 2 WEEKS, THEN BID X 2 WEEKS (TOTAL DURATION: 1 MONTH) OFLOXACIN 0.3%: 1 GTT QID X 7 DAYS KETOROLAC 0.5%: 1 GTT QID X 2 WEEKS, THEN BID X 2 WEEKS (TOTAL DURATION: 1 MONTH) MEDICATIONS DOCUMENTED AT RETINA VISIT ON (B)(6) 2026: PREDNISOLONE ACETATE: 1% 1 GTT KETOROLAC 0.5%: 1 GTT TID OFLOXACIN 0.3%: 1 GTT QID CYCLOPENTOLATE 1%: 1 GTT TID.
Patient problems: Endophthalmitis; Hypopyon; Visual Impairment; Vitreous Floaters
MAUDE report 25551740 ↗InjuryJun 18, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT 2 DAYS AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) IN THE LEFT EYE, THE PATIENT PRESENTED WITH HYPOPYON AND VITRITIS. BASED ON THE FINDINGS, THE SURGEON CONCLUDED THE CAUSE AS ENDOPHTHALMITIS. IN THE IMPLANTING SURGEON'S OPINION, THE MOST LIKELY CAUSE OF THE EVENT COULD NOT BE DETERMINED. MEDICATION ADMINISTERED DURING ORIGINAL SURGERY: INTRACAMERAL MOXIFLOXACIN THE FOLLOWING MEDICATIONS WERE PRESCRIBED FOR USE AT HOME POST-OPERATIVELY: PREDNISOLONE 1%: 1 GTT QID X 2 WEEKS, THEN TID X 2 WEEKS (TOTAL DURATION: 1 MONTH) OFLOXACIN 0.3%: 1 GTT QID X 7 DAYS. KETOROLAC 0.5%: 1 GTT QID X 2 WEEKS, THEN TID X 2 WEEKS (TOTAL DURATION: 1 MONTH).
Patient problems: Endophthalmitis; Hypopyon
MAUDE report 25551694 ↗InjuryJun 5, 2026Device Dislodged or Dislocated; Migration
IT WAS REPORTED THAT ONE DAY AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) IN THE RIGHT EYE (OD), THE PATIENT HAD CLOUDY VISION AND FOREIGN BODY SENSATION IN THE OPERATED EYE. PER THE SURGEON THE LENS BECAME DISLOCATED. TWO DAYS POSTOPERATIVELY, A SECONDARY PROCEDURE WAS PERFORMED TO REPOSITION THE IOL WITH NO SUCCESS. APPROXIMATELY ONE WEEK POST ORIGINAL IMPLANT, THE IOL WAS REMOVED AND REPLACED WITH A DIFFERENT MODEL LENS. THE PATIENT SUBSEQUENTLY EXPERIENCED POSTOPERATIVE INFLAMMATION WHICH WAS TREATED WITH STEROID/ANTIBIOTICS DROPS AS EXPECTED AND CONSISTENT WITH THE STANDARD COURSE OF MULTIPLE PROCEDURES.
Patient problems: Blurred Vision; Foreign Body Sensation in Eye; Swelling/ Edema
MAUDE report 25414130 ↗InjuryJun 2, 2026Break
IT WAS REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE HAPTIC WAS TORN. THE INCISION WAS ENLARGED AND A DIFFERENT MODEL IOL WAS IMPLANTED. A SUTURE WAS USED TO HELP CLOSE THE WOUND. POST OPERATIVELY THE PATIENT WAS DIAGNOSED WITH CORNEAL EDEMA AND INFLAMMATION, HOWEVER ACCORDING TO THE SURGEON THE PATIENT IS IMPROVING. IN THE SURGEON¿S OPINION THE MOST LIKELY CAUSE OF THE EVENT IS THE MANNER LENS WAS LOADED INTO THE CARTRIDGE BY THE SCRUB TECH.
Patient problems: Corneal Edema; Inflammation
MAUDE report 25368664 ↗InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED ABOUT THREE MONTHS AFTER IMPLANTATION DUE TO THE PATIENT EXPERIENCING DYSPHOTOPSIA. A SECOND IOL OF A DIFFERENT MODEL WAS IMPLANTED. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED.
Patient problems: Visual Disturbances
MAUDE report 25253552 ↗InjuryApr 17, 2026Particulates
THE HEALTHCARE FACILITY REPORTED AN AC WASHOUT (ANTERIOR CHAMBER) WAS REQUIRED TWO (2) MONTHS AFTER AN INTRAOCULAR LENS (IOL) IMPLANTATION. IT WAS ORIGINALLY THOUGHT TO BE RETAINED CAPSULORHEXIS AT 3PM POSITION, EXTENDING THROUGH AC CLOSE TO ENDOTHELIUM. AFTER ASSESSMENT BY THE SURGEON IT WAS FOUND TO BE OF FOREIGN BODY APPEARANCE. AT FOLLOW-UP ONE WEEK POST AC WASHOUT, THE PATIENT DID NOT NOTE ANY SYMPTOMS AND WAS HAPPY WITH THE OUTCOME.
Patient problems: Insufficient Information
MAUDE report 24912616 ↗InjuryFeb 12, 2026Insufficient Device Problem Information
A CONSUMER REPORTED THAT POST IOL (INTRAOCULAR LENS) SURGERY THEY DEVELOPED GLARES AND HALOS IN THE DARK AND EXPERIENCED DIFFICULTY SEEING THEIR COMPUTER. THE IOL WAS EXPLANTED AND REPLACED WITH A NEW ONE OF AN UNKNOWN MODEL AND POWER. THE CONSUMER CONFIRMED THEIR SYMPTOMS RESOLVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT RECEIVED.
Patient problems: Halo; Visual Disturbances
MAUDE report 24321148 ↗InjurySep 8, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT APPROXIMATELY 3 YEARS AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE RIGHT EYE (OD), THE LENS WAS REMOVED, A VITRECTOMY WAS PERFORMED, AND A DIFFERENT MODEL IOL WAS IMPLANTED. IN THE SURGEON'S OPINION, THE MOST LIKELY CAUSE OF THE EVENT IS THE LENS DISLODGED.
Patient problems: Insufficient Information
MAUDE report 22993485 ↗InjurySep 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER AN IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE EYE, THE PATIENT WAS UNHAPPY WITH THE OUTCOME AND WAS SEEING AN ARCH. APPROXIMATIVELY ONE MONTH LATER, THE LENS WAS EXCHANGED WITH A DIFFERENT MODEL IOL DUE TO DYSPHOTOPSIA. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED.
Patient problems: Visual Disturbances
MAUDE report 22955314 ↗InjuryJul 31, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT 1-DAY AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE RIGHT EYE (OD), THE PATIENT PRESENTED WITH TRACE EDEMA AND ANTERIOR CHAMBER FIBERING 4-5+ CELLS. BASED ON THE FINDINGS THE SURGEON CONCLUDED THE CAUSE AS TOXIC ANTERIOR SEGMENT SYNDROME (TASS). A TAP & INJECT WAS PERFORMED BY A RETINA SPECIALIST THE SAME DAY FOR VITRITIS. IN THE SURGEON'S OPINION, THE MOST LIKELY CAUSE OF EVENT WAS TASS-ENDOPHTHALMITIS. PATIENT OUTCOME REPORTED AS VISUAL ACUITY OF 20/30-2. THE FOLLOWING MEDICATIONS WERE PRESCRIBED FOR USE AT HOME POST-OPERATIVELY: OFOXIN 1 DROP EVERY 2 HOURS. PREDNISOLONE 1 DROP EVERY 2 HRS 3+ MONTHS.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Swelling/ Edema; Toxic Anterior Segment Syndrome (TASS); Vitritis
MAUDE report 22675389 ↗InjuryJul 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT APPROXIMATELY THREE MONTHS AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE RIGHT EYE (OD), THE PATIENT COMPLAINED OF SYMPTOMS CONSISTENT WITH NEGATIVE DYSPHOTOPSIA. THE PATIENT DID NOT NOTICE A DECREASE IN VISION. APPROXIMATELY 10 WEEKS AFTER THE ONSET OF SYMPTOMS, THE LENS WAS EXCHANGED WITH A DIFFERENT MODEL IOL. PATIENT OUTCOME IS GOOD.
Patient problems: Visual Disturbances
MAUDE report 22479889 ↗InjuryJun 25, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT TWO DAYS AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE RIGHT EYE, THE PATIENT COMPLAINED OF BLURRY VISION, PHOTOPHOBIA, PAIN, AND EYE REDNESS/IRRITATION. SLIT LAMP FINDINGS WERE CORNEAL EDEMA, DIFFUSE D FOLDS, 2-3+ CELL/FLARE, AND FIBRIN/OPACITY COVERING IOL. THE PATIENT¿S BEST CORRECT VISUAL ACUITY (BCVA) DECREASED FROM 20/50 TO 20/150. THE PATIENT WAS RE-EDUCATED ON EYE DROP ADMINISTRATION AND COMPLIANCE AND CLOSELY MONITORED OVER NEXT FEW WEEKS AND DID NOT SHOW MUCH IMPROVEMENT. APPROXIMATELY ONE MONTH AFTER THE ONSET OF SYMPTOMS, A VITREOUS TAP WAS PERFORMED, AND INJECTIONS OF VANCOMYCIN, CEFTAZIDIME AND DEXAMETHASONE WERE ADMINISTERED. THE PATIENT WAS PRESCRIBED ORAL STEROIDS. THE CULTURE HAD NO GROWTH. 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 UNCLEAR, BUT FAVORS TASS, STATING THAT THE FINDINGS WERE INCONSISTENT WITH INFECTIOUS ENDOPHTHALMITIS VS. ROBUST INFLAMMATORY RESPONSE WITH CYSTOID MACULAR EDEMA. PATIENT HAS PERSISTENT MACULAR EDEMA AND CORNEAL EDEMA/DESCEMET'S FOLDS. MEDICATIONS PRESCRIBED FOR USE AT HOME POST-OPERATIVE
Patient problems: Blurred Vision; Corneal Edema; Eye Irritation; Eye Pain; Macular Edema; Photophobia; Toxic Anterior Segment Syndrome (TASS)
MAUDE report 22331520 ↗InjuryJun 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A SURGERY CENTER REPORTED THAT AFTER AN 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. PER THE SURGEON THE LIKELY CAUSE OF EVENT WAS THE PATIENT WAS UNHAPPY WITH THE VISON RESULTS AS THERE WAS NO DAMAGE TO THE LENS. POST EXCHANGE OUTCOME IS REPORTED AS GOOD.
Patient problems: Visual Disturbances
MAUDE report 22197252 ↗
Other Bausch & Lomb Incorporated products
- 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
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page