SENSAR IOL AR40M (REF AR40MN0065)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · ACRY 13.5mm 6 OPT MOD C PMMA OPTIEDGE · 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474514287), received between Jan 19, 2021 and Oct 2, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 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
- Break2
- Material Fragmentation1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 2, 2023Break; Material Fragmentation; Break; Material Fragmentation
IT WAS REPORTED THAT THE NON-PRELOADED INTRAOCULAR LENS (IOL) WAS OPENED AND INSERTED IN EYE, THEN REMOVED. REPORTEDLY PER SURGEON, THE BACKUP LENS WAS OPENED, LOADED MORE CAREFULLY INTO INJECTOR AND WAS ALMOST PERPENDICULAR TO THE PLANE OF THE LENS. IN ADDITION THE LAGGING HAPTIC HAD SLOUGHED OFF ALONG WITH A PIECE OF THE LENS AS IT CAME OUT OF THE INJECTOR. AFTER INSPECTING THIS CAREFULLY, DECISION WAS MADE TO REMOVE THIS LENS. THERE WAS NO PATIENT INJURY. EMERALD CARTRIDGE WAS USED. LENS IS AVAILABLE FOR RETURN, CARTRIDGE WAS DISPOSED IN MEDICAL WASTE. ADDITIONAL INFORMATION STATED THAT LENS WAS INJECTED INTO THE ANTERIOR CHAMBER THROUGH AN ENLARGED PRIMARY INCISION. LENS FROM ANOTHER MANUFACTURER WAS USED AS BACK UP LENS TO COMPLETE THE SURGERY IN THE PATIENTS RIGHT EYE. IT WAS UNKNOWN HOW IS PATIENT DOING AFTER SURGERY AND WHETHER THERE WAS USE ERROR. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 17851848 ↗MalfunctionJan 19, 2021Break; Break
IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAD BROKEN HAPTIC AND WAS REMOVED AND REPLACED FROM PATIENT EYE. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PROCEDURE WAS COMPLETED USING ANOTHER LENS OF SAME MODEL AND DIOPTER. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11197921 ↗
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 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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