enVista® IOL MX60E (REF MXUE2100)Recalls & reported problems
Bausch & Lomb Incorporated · enVista one-piece hydrophobic acrylic intraocular lens +21.00D · Class 3 · Implant
All models of enVista IOL (74)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10757770531353), received between Oct 2, 2024 and Oct 18, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Material Opacification” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Material Opacification1
Patient problems
- Blurred Vision1
- Loss of Vision1
- Toxic Anterior Segment Syndrome (TASS)1
- Visual Disturbances1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 18, 2024Material Opacification; Material Opacification
IT WAS REPORTED ONE DAY POST IMPLANT OF AN INTRAOCULAR LENS (IOL) INTO THE LEFT EYE (OS) IN A COMBINE CATARACT AND MIGS PROCEDURE. THE IOL APPEARED TO HAVE DROP LIKE CONDENSATION ON BOTH THE ANTERIOR AND POSTERIOR SURFACES, DEVELOPING FURTHER OPACIFICATIONS ON THE POSTERIOR SURFACE OF THE IOL OVER THE COURSE OF THE FIRST POST-OPERATIVE WEEK. AT THREE WEEKS POST OP, THE PATIENT'S ANTERIOR CHAMBER (AC) INFLAMMATION WAS RESOLVED, BUT THE PATIENT WAS UNHAPPY WITH THE VISUAL OUTCOME STATING IT WAS FOGGY AND GLARE INDUCING. A SUCCESSFUL LENS EXCHANGE WAS COMPLETED APPROXIMATELY SIX WEEKS POST IMPLANT USING A DIFFERENT MODEL IOL. THE PATIENT'S OUTCOME IS FAIR AND STABLE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT RECEIVED.
Patient problems: Blurred Vision; Visual Disturbances
MAUDE report 20480704 ↗InjuryOct 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED ONE DAY POST IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE RIGHT (OD) EYE, THE PATIENT EXPERIENCED SYMPTOMS THAT WERE LATER DIAGNOSED AS TASS AND PATIENT HAD A DECREASE IN VISION. AN INTRAOCULAR INJECTION WAS ADMINISTERED. IN THE SURGEON'S OPINION, THE LIKELY CAUSE OF THE EVENT WAS THE IOL. THE PATIENT'S OUTCOME IS GOOD. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAS NOT BEEN RECEIVED.
Patient problems: Loss of Vision; Toxic Anterior Segment Syndrome (TASS)
MAUDE report 20352222 ↗
Other intraocular lens devices
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens146 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens145 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens144 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens139 reports
- TECNIS SIMPLICITY DIB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens1 recall81 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens127 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens126 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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