SENSAR IOL AR40e (REF AR40E00095)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
- 5
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474514133), received between Apr 30, 2021 and Jul 15, 2025 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Break” (4 reports).
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
- Break4
- Adverse Event Without Identified Device or Use Problem1
- Difficult to Advance1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Visual Impairment1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 15, 2025Break; Break
IT WAS REPORTED THAT A MONOFOCAL INTRAOCULAR LENS (IOL) HAD A DAMAGE HAPTIC. THERE WAS PATIENT CONTACT REPORTED AND REMOVED. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22516297 ↗MalfunctionMay 23, 2024Break; Break
IT WAS REPORTED THAT THE MONOFOCAL NON PRELOADED INTRAOCULAR LENS (IOL) HAPTIC WAS FOUND TO BE BENT AFTER LENS INJECTION. THERE WERE NO COMPLICATIONS AND PATIENT FELT WELL. ADDITIONAL INFORMATION STATED THAT THE LENS WAS REMOVED ON SAME DAY. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19388102 ↗InjuryJul 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S RIGHT EYE DUE TO REFRACTIVE SURPRISE. REPORTEDLY, THE SYMPTOMS PERSISTED BETWEEN SURGERIES. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Visual Impairment
MAUDE report 17387148 ↗MalfunctionFeb 7, 2023Break; Break
IT WAS REPORTED THAT DURING IMPLANTATION OF THE INTRAOCULAR LENS (IOL) INTO PATIENT'S OPERATIVE EYE, IT WAS IDENTIFIED THAT THE LENS WAS FAULTY. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16314806 ↗MalfunctionApr 30, 2021Break; Difficult to Advance; Break; Difficult to Advance
IT WAS REPORTED THAT WHILE INSERTING AN INTRAOCULAR LENS (IOL), THE TRAILING HAPTIC BENT WHEN ADVANCING THE LENS INSIDE THE CARTRIDGE/INSERTER. SURGEON STOPPED ADVANCING THE LENS WHEN IOL WAS PARTIALLY INSERTED AND WAS ABLE TO REMOVE THE IOL SAFELY BEFORE IT WAS FULLY INSERTED INTO THE EYE. NO POST-OP INJURY OCCURRED. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11751237 ↗
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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