SENSAR IOL AR40e (REF AR40E00110)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
- 7
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05050474501935), received between Oct 11, 2022 and Aug 11, 2026 — classified as 2 injuries, 5 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
- Material Fragmentation2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Visual Disturbances1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryAug 11, 2026Break
It was reported that the non-preloaded monofocal intraocular lens (IOL) was implanted in the patient's operative eye; however, following implantation, it was noted that the lens had a broken haptic. An AR40 12.0D lens was ordered, and a lens exchange was planned. Through follow up we learned that the lens was explanted on (b)(6) 2026. However, the surgeon decided to postpone implantation of a replacement lens, as the eye was not in a suitable condition to receive a new IOL at that time. No additional information was provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50211697 ↗MalfunctionMar 3, 2026Break
IT WAS REPORTED THAT THE STANDALONE INTRAOCULAR LENS (IOL) WAS DEFECTIVE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24503460 ↗MalfunctionAug 20, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE THREE PIECE INTRAOCULAR LENS (IOL) WAS DEFECTIVE. THROUGH FOLLOW UPS WE LEARNED THAT THE LENS WAS IMPLANTED AND THE HAPTICS DID NOT SEEM RIGHT, THEY APPEARED TOO SHORT. DURING IMPLANTATION, A HAPTIC WAS BROKEN OFF WITH THE CANNULA. AS A RESULT, THE LENS NO LONGER HELD AND A NEW LENS WITH THE SAME MODEL AND DIOPTER WAS IMPLANTED INSTEAD. NO FURTHER DETAILS WERE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20003466 ↗MalfunctionMay 23, 2024Break; Break
IT WAS REPORTED THAT THERE WAS A FAULTY NON PRELOADED INTRAOCULAR LENS AS HAPTIC BROKE IN INJECTOR. ISSUE WAS NOTICED DURING IMPLANTATION. LENS WAS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19388626 ↗MalfunctionJul 27, 2023Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS IMPLANTED BY THE DOCTOR IN THE PATIENT'S RIGHT EYE; HOWEVER, AFTER INSERTING THE IOL INTO THE EYE, THE DOCTOR NOTICED THAT ONE OF THE HAPTICS GOT STUCK IN THE CARTRIDGE. THE DOCTOR EXPLANTED THE IOL IMMEDIATELY AND IMPLANTED ANOTHER LENS OF THE SAME MODEL. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 17406391 ↗MalfunctionMar 7, 2023Break; Break
IT WAS REPORTED THAT THE HAPTIC WAS BROKEN DURING INSERTION OF THE INTRAOCULAR LENS (IOL) INTO THE PATIENT'S OPERATIVE EYE. THE IOL WAS PARTIALLY INSERTED INTO THE EYE. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16499818 ↗InjuryOct 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER THE INTRAOCULAR LENS (IOL) WAS FULLY INSERTED IN THE PATIENT'S LEFT EYE, THE PATIENT EXPERIENCED "OTHER" VISUAL DISTURBANCES WHICH WAS OBSERVED DURING A POST-OPERATIVE EXAMINATION. THE SYMPTOMS PERSISTED FOR THE AMOUNT OF TIME BETWEEN SURGERIES. THE IOL WAS EXPLANTED. THE INCISION WAS ENLARGED. NO SUTURES OR VITRECTOMY WAS REQUIRED. NO MEDICATION WAS PRESCRIBED. DIRECTIONS FOR USE WERE FOLLOWED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Visual Disturbances
MAUDE report 15577494 ↗
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- 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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