enVista® IOL MX60E (REF MXUE1650)Recalls & reported problems
Bausch & Lomb Incorporated · enVista one-piece hydrophobic acrylic intraocular lens +16.50D · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10757770531186), received between Oct 3, 2024 and Oct 3, 2024 — classified as 1 injury.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Loss of Vision1
- Toxic Anterior Segment Syndrome (TASS)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 3, 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 LEFT (OS) EYE, THE PATIENT EXPERIENCED SYMPTOMS THAT WERE LATER DIAGNOSED AS TASS. SLIT LAMP FINDINGS FOUND FIBRIN IN THE AC, AND THE PATIENT HAD A DECREASE IN VISION. A CULTURE WAS TAKEN. AN INTRAVITREAL STEROID INJECTION WAS ADMINISTERED TWO DAYS POST IMPLANT. THE RESULTS OF THE CULTURE AND SENSITIVITY WERE NEGATIVE. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Loss of Vision; Toxic Anterior Segment Syndrome (TASS)
MAUDE report 20359850 ↗
Other intraocular lens devices
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- 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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