SENSAR IOL AR40M (REF AR40MN0025)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
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05050474514249), received between Jun 9, 2017 and Dec 15, 2023 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Break” (6 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
- Break6
- Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Consequences Or Impact To Patient3
- No Information1
- No Patient Involvement1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 15, 2023Break; Break
IT WAS REPORTED THERE WAS HAPTIC DAMAGED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18337004 ↗MalfunctionAug 21, 2023Break; Break
IT WAS REPORTED THAT THE PARTIALLY INSERTED LENS WAS REMOVED AND REPLACED IN THE SAME PROCEDURE DUE TO A BENT HAPTIC. THE PROCEDURE WAS COMPLETED WITH ANOTHER IOL WITH THE SAME MODEL. THERE WAS NO PATIENT INJURY. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17591766 ↗MalfunctionJun 28, 2022Break; Break
IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS REMOVED FROM PATIENT'S OPERATIVE EYE AS THE TRAILING HAPTIC WAS DAMAGED, MOST LIKELY WHEN LOADING THE LENS. ANOTHER LENS WAS PROPERLY LOADED AND INSERTED INTO THE EYE. THE PROCEDURE ENDED WELL. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14848510 ↗MalfunctionApr 27, 2020Break; Break
THIS REPORT SUMMARIZES <NOE> 4 </NOE> MALFUNCTION EVENTS. THE EVENTS WERE RELATED TO LENS DAMAGED. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10002944 ↗MalfunctionJan 29, 2020Break; Break
THIS REPORT SUMMARIZES <NOE> 4 </NOE> MALFUNCTION EVENTS. THE EVENTS WERE RELATED TO LENS DAMAGED. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9644876 ↗MalfunctionOct 28, 2019Break; Break
THIS REPORT SUMMARIZES <NOE> 5 </NOE> MALFUNCTION EVENTS. THE EVENTS WERE RELATED TO LENS DAMAGED. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9247855 ↗MalfunctionJun 9, 2017Bent; Bent
IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD AN HAPTIC BENT. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Information; No Patient Involvement
MAUDE report 6632637 ↗
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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