SENSAR IOL AR40M (REF AR40MN0070)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 05050474501751), received between Nov 1, 2018 and Apr 29, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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.
Most reported problems
Device problems
- Break1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 29, 2021Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) SPLIT IN HALF WHILE IN THE INSERTER DURING SURGERY. IT IS UNKNOWN IF THE LENS CAME INTO CONTACT WITH THE PATIENT'S EYE. THERE WAS NO ADDITIONAL SURGICAL INTERVENTION PERFORMED. THERE WAS NO REPORT OF PATIENT INJURY. THE CUSTOMER INDICATED THAT THE LENS WAS DISCARDED. NO FURTHER INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11743135 ↗MalfunctionNov 1, 2018Break; Break
IT WAS REPORTED THAT AN AR40M, 7.0 DIOPTER INTRAOCULAR LENS (IOL) WAS INSERTED INTO THE EYE, AND WAS THEN NOTICED TO HAVE THE LEAD HAPTIC PUNCHED AND BROKEN. THE LENS WAS REMOVED AND REPLACED WITH THE SAME MODEL LENS. THERE WAS NO MEDICAL INTERVENTION REQUIRED, NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO SUTURES PERFORMED. NO ADDITIONAL INFORMATION WAS RECEIVED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8027207 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page