enVista Aspire IOLRecalls & reported problems across all models
Bausch & Lomb Incorporated · 57 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 Aspire IOL model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls
- 1
We found 57 models of enVista Aspire IOL by Bausch & Lomb Incorporated in the FDA's device registry (GUDID). Together they are named in 10 adverse event reports in the FDA's MAUDE database, received between May 24, 2024 and Feb 20, 2026 — classified as 10 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 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 57 of these models · Recall details · FDA record ↗
Most reported enVista Aspire IOL problems
Device problems
- Insufficient Device Problem Information6
- Adverse Event Without Identified Device or Use Problem3
- Break2
Patient problems
- Toxic Anterior Segment Syndrome (TASS)5
- Visual Impairment4
- Hypopyon2
- No Clinical Signs, Symptoms or Conditions2
- Blurred Vision1
- Capsular Bag Tear1
- Corneal Edema1
- Eye Pain1
enVista Aspire IOL models
57 models, most reported first. Each model has its own page with its reports, recalls and device details.
- enVista Aspire™ IOL EAIntraocular Lens1 recall2 reports
- enVista Aspire™ IOL EAIntraocular Lens1 recall1 report
- enVista Aspire™ IOL EAIntraocular Lens1 recall1 report
- enVista Aspire™ IOL EAIntraocular Lens1 recall1 report
- enVista Aspire™ IOL EAIntraocular Lens1 recall1 report
- enVista Aspire™ IOL EAIntraocular Lens1 recall1 report
- enVista Aspire™ IOL EAIntraocular Lens1 recall1 report
- enVista Aspire™ IOL EAIntraocular Lens1 recall1 report
- enVista Aspire™ IOL EAIntraocular Lens1 recall1 report
- enVista Aspire™ IOL EAIntraocular Lens1 recall0 reports
- enVista Aspire™ IOL EAIntraocular Lens1 recall0 reports
- enVista Aspire™ IOL EAIntraocular Lens1 recall0 reports
- enVista Aspire™ IOL EAIntraocular Lens1 recall0 reports
- enVista Aspire™ IOL EAIntraocular Lens1 recall0 reports
- enVista Aspire™ IOL EAIntraocular Lens1 recall0 reports
- enVista Aspire™ IOL EAIntraocular Lens1 recall0 reports
- enVista Aspire™ IOL EAIntraocular Lens1 recall0 reports
- enVista Aspire™ IOL EAIntraocular Lens1 recall0 reports
- enVista Aspire™ IOL EAIntraocular Lens1 recall0 reports
- enVista Aspire™ IOL EAIntraocular Lens1 recall0 reports
- enVista Aspire™ IOL EAIntraocular Lens1 recall0 reports
- enVista Aspire™ IOL EAIntraocular Lens1 recall0 reports
- enVista Aspire™ IOL EAIntraocular Lens1 recall0 reports
- enVista Aspire™ IOL EAIntraocular Lens1 recall0 reports
- enVista Aspire™ IOL EAIntraocular Lens1 recall0 reports
- enVista Aspire™ IOL EAIntraocular Lens1 recall0 reports
- enVista Aspire™ IOL EAIntraocular Lens1 recall0 reports
- enVista Aspire™ IOL EAIntraocular Lens1 recall0 reports
- enVista Aspire™ IOL EAIntraocular Lens1 recall0 reports
- enVista Aspire™ IOL EAIntraocular Lens1 recall0 reports
- enVista Aspire™ IOL EAIntraocular Lens1 recall0 reports
- enVista Aspire™ IOL EAIntraocular Lens1 recall0 reports
- enVista Aspire™ IOL EAIntraocular Lens1 recall0 reports
- enVista Aspire™ IOL EAIntraocular Lens1 recall0 reports
- enVista Aspire™ IOL EAIntraocular Lens1 recall0 reports
- enVista Aspire™ IOL EAIntraocular Lens1 recall0 reports
- enVista Aspire™ IOL EAIntraocular Lens1 recall0 reports
- enVista Aspire™ IOL EAIntraocular Lens1 recall0 reports
- enVista Aspire™ IOL EAIntraocular Lens1 recall0 reports
- enVista Aspire™ IOL EAIntraocular Lens1 recall0 reports
- enVista Aspire™ IOL EAIntraocular Lens1 recall0 reports
- enVista Aspire™ IOL EAIntraocular Lens1 recall0 reports
- enVista Aspire™ IOL EAIntraocular Lens1 recall0 reports
- enVista Aspire™ IOL EAIntraocular Lens1 recall0 reports
- enVista Aspire™ IOL EAIntraocular Lens1 recall0 reports
- enVista Aspire™ IOL EAIntraocular Lens1 recall0 reports
- enVista Aspire™ IOL EAIntraocular Lens1 recall0 reports
- enVista Aspire™ IOL EAIntraocular Lens1 recall0 reports
- enVista Aspire™ IOL EAIntraocular Lens1 recall0 reports
- enVista Aspire™ IOL EAIntraocular Lens1 recall0 reports
- enVista Aspire™ IOL EAIntraocular Lens1 recall0 reports
- enVista Aspire™ IOL EAIntraocular Lens1 recall0 reports
- enVista Aspire™ IOL EAIntraocular Lens1 recall0 reports
- enVista Aspire™ IOL EAIntraocular Lens1 recall0 reports
- enVista Aspire™ IOL EAIntraocular Lens1 recall0 reports
- enVista Aspire™ IOL EAIntraocular Lens1 recall0 reports
- enVista Aspire™ IOL EAIntraocular Lens1 recall0 reports
Recent enVista Aspire IOL adverse event reports
The 10 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryFeb 20, 2026Break
A SURGERY CENTER REPORTED UPON INSERTION OF AN INTRAOCULAR LENS (IOL) INTO THE LEFT EYE THE TRAILING HAPTIC HAD A TEAR. THE INCISION WAS ENLARGED TO 3.5MM AND THE IOL WAS REMOVED. A BACK UP IOL OF THE SAME MODEL AND DIOPTER WAS SUCCESSFULLY IMPLANTED. THE PATIENT HAS SINCE RECOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24400872 ↗InjuryFeb 4, 2026Insufficient Device Problem Information
A CONSUMER REPORTED THAT AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) IN THE RIGHT EYE (OD), THEY EXPERIENCED FLUID IN THE EYE FOR APPROXIMATELY 4¿5 MONTHS. ACCORDING TO THE CONSUMER, THE SURGEON PRESCRIBED ANTI-INFLAMMATORY DROPS AND THE FLUID SUBSEQUENTLY RESOLVED. DESPITE THE REPORTED RESOLUTION OF THE FLUID, THE CONSUMER ALLEGED THEY WERE UNABLE TO SEE DISTANCE AND COULD ONLY SEE NEAR. THE CONSUMER STATED THAT A LASER PROCEDURE WAS PERFORMED APPROXIMATELY SEVEN MONTHS POST-OPERATIVELY; HOWEVER, DISTANCE VISION DID NOT IMPROVE FOLLOWING THE PROCEDURE. THE CONSUMER FURTHER REPORTED THAT THE SURGEON INFORMED HER THAT THE REASON FOR THE ONGOING VISUAL ISSUES WAS DUE TO SCAR TISSUE FORMATION IN THE EYE FROM THE PRIOR FLUID ACCUMULATION. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED.
Patient problems: Retinal Tear; Scar Tissue; Unspecified Eye / Vision Problem; Visual Impairment
MAUDE report 24257678 ↗InjuryOct 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING INSERTION OF AN INTRAOCULAR LENS (IOL) INTO THE RIGHT EYE (OD) THE CAPSULE RUPTURED, AND THE IOL DROPPED THROUGH THE DEFECT IN THE CAPSULAR BAG. THE IOL WAS REMOVED, A VITRECTOMY WAS PERFORMED, AND A DIFFERENT MODEL IOL WAS IMPLANTED INTO THE SULCUS. IN THE SURGEON'S OPINION, THE MOST LIKELY CAUSE OF THE EVENT WAS THE IOL DROPPED THROUGH CAPSULAR DEFECT. THE PATIENT'S OUTCOME IS GOOD.
Patient problems: Capsular Bag Tear
MAUDE report 23360956 ↗InjuryApr 24, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT ONE DAY AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE LEFT EYE, THE PATIENT PRESENTED WITH CELL AND FIBRIN. BASED ON THE FINDINGS THE SURGEON CONCLUDED THE CAUSE AS TOXIC ANTERIOR SEGMENT SYNDROME (TASS). THE PATIENT WAS TREATED WITH MOXI, BROM AND PRED AND AN ANTIBIOTIC INJECTION. IN THE SURGEON'S OPINION, THE MOST LIKELY CAUSE OF THE EVENT WAS TASS. PATIENT OUTCOME WAS REPORTED TO BE GOOD.
Patient problems: Toxic Anterior Segment Syndrome (TASS)
MAUDE report 21902622 ↗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 EYE, THE PATIENT PRESENTED WITH INCREASED BLURRY VISION. PATIENT HAD ABOUT 3+ CELL BUT NO HYPOPYON. TOPICAL STEROIDS WERE INCREASED AND ON THE NEXT DAY, THE AC CELL WAS SLIGHTLY IMPROVED BUT VISION WAS DECREASED WITH VITREOUS HAZE. BASED ON THE FINDINGS THE SURGEON CONCLUDED THE CAUSE AS TOXIC ANTERIOR SEGMENT SYNDROME (TASS). INTRAVITREAL ANTIBIOTIC INJECTION WERE GIVEN. THE PATIENT IS DOING WELL AND THE VITREOUS HAZE RESOLVED. VISUAL ACUITY CORRECTABLE TO 20/20.
Patient problems: Toxic Anterior Segment Syndrome (TASS); Visual Impairment; Vitreous Floaters
MAUDE report 21894068 ↗InjuryApr 17, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT 1 DAY AFTER OF IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE RIGHT EYE (OD), THE PATIENT PRESENTED WITH HYPOPYON, CELL, AND FIBRIN IN AC. 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 THE IOL. THE PATIENT OUTCOME IS GOOD, RESOLVING WITH STEROID USE. THE FOLLOWING MEDICATIONS WERE PRESCRIBED (FOR USE AT HOME POST-OPERATIVELY): MOXI 0.5%-PRED 1%-BROMFENAC 0.075% QID 1 WEEK, PRED 10MG 40MG, 30MG, 20MG, 10MG TAPER. PF QH 1 WEEK.
Patient problems: Hypopyon; Toxic Anterior Segment Syndrome (TASS)
MAUDE report 21860569 ↗InjuryApr 17, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
ADDITIONAL INFORMATION WAS OBTAINED FROM THE SURGEON. THE PATIENT IS HIGH PROFILE AND SUTURE WAS NEEDED TO REDUCE THE RISK OF INFECTION. THE PATIENT IS NOW 20/20 UNAIDED, MANIFEST REFRACTION IS PLANO, AND INFLAMMATION HAS RESOLVED.
Patient problems: Corneal Edema; Hypopyon; Intraocular Pressure Increased; Toxic Anterior Segment Syndrome (TASS); Visual Impairment
MAUDE report 21853463 ↗InjuryFeb 25, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT THE FIBROUS MEMBRANE WAS ON THE ANTERIOR OPTIC OF THE LENS. THE PATIENT IS RECOVERING.
Patient problems: Toxic Anterior Segment Syndrome (TASS); Visual Impairment
MAUDE report 21463099 ↗InjuryNov 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE LEFT EYE (OS), THE PATIENT COMPLAINED OF BLURRY VISION TO THE POINT OF PAIN. A SUCCESSFUL LENS EXCHANGE WAS PERFORMED TWO WEEKS AFTER INITIAL IMPLANT USING THE SAME MODEL, DIFFERENT DIOPTER IOL. IN THE SURGEON'S OPINION, THE MOST LIKELY CAUSE OF THE EVENT WAS THE VALUES FOR THE SURGEON FACTOR AND ACD CONSTANT. ONCE CORRECTIONS WERE MADE, THE PROPER LENS POWER WAS CHOSEN & WORKED PERFECTLY AFTER LENS EXCHANGE. THE PATIENT'S OUTCOME WAS GOOD.
Patient problems: Blurred Vision; Eye Pain
MAUDE report 20682969 ↗InjuryMay 24, 2024Break; Break
IT WAS REPORTED THAT UPON DELIVERY OF AN INTRAOCULAR LENS (IOL) INTO THE EYE, THE SURGEON NOTICED THE HAPTIC WAS DAMAGED. UNDER MICROSCOPIC EXAMINATION, THE SURGEON DISCOVERED THE VERY TIP OF TRAILING HAPTIC WAS MISSING AND NOT IN THE EYE, IT WAS IN THE INJECTOR CARTRIDGE. THE INCISION WAS ENLARGED TO ALLOW FOR REMOVAL OF THE IOL AND A SUCCESSFUL INTRAOPERATIVE LENS EXCHANGE WAS PERFORMED USING A BACKUP IOL OF THE SAME MODEL AND DIOPTER. PATIENT OUTCOME IS GOOD. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19392775 ↗
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
- Akreos IOL8 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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