SENSAR IOL AR40e (REF AR40E00100)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · AMO Sensar AR40e Lens · Class 3 · Implant
All models of SENSAR IOL (112)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474501928), received between Dec 31, 2024 and May 8, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Material Fragmentation” (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
- Appropriate Device Problem Term/Code Not Available1
- Material Fragmentation1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 8, 2026Material Fragmentation; Use of Device Problem
IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS IMPLANTED AND THEN REMOVED DURING THE SAME PROCEDURE. THE SURGEON BROKE THE HAPTIC WHILE IT WAS IN THE PATIENT¿S EYE. A PARTIAL ANTERIOR VITRECTOMY WAS PERFORMED AND SUTURES WERE REQUIRED. THE IOL WAS REPLACED WITH A JOHNSON AND JOHNSON MODEL AR40E 10.0 DIOPTER. THE PATIENT IS DOING WELL PER THE SURGEON. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25124801 ↗MalfunctionDec 31, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE NON PRELOADED INTRAOCULAR LENS(IOL) WAS IMPLANTED AND OBSERVED TO BE DAMAGED DUE TO CRACK IN THE LENS. SO THE LENS WAS REMOVED AND REPLACED WITH DIB00 WITH 19.5 DIOPTER IN THE SAME PROCEDURE. NO OTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21048548 ↗
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.
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