SENSAR IOL AR40M (REF AR40MN0050)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
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474501775), received between Mar 20, 2022 and Jul 18, 2025 — classified as 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 Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 18, 2025Break; Break
IT WAS REPORTED THAT THE MONOFOCAL STANDALONE INTRAOCULAR LENS (IOL) WAS BROKEN. THROUGH FOLLOW-UP, IT WAS REPORTED THAT THE ISSUE WITH THE LENS OCCURRED WHILE ATTEMPTING TO IMPLANT IT. THE LENS CAME OUT PARTIALLY AND WAS IN CONTACT WITH THE PATIENT'S EYE, BUT IT WAS REINSERTED INTO THE CARTRIDGE WHEN ONE OF THE HAPTICS WAS NOTICED TO BE BENT. THE IOL WAS ATTEMPTED TO BE MOUNTED AGAIN, BUT IT NO LONGER CAME OUT PROPERLY AND WAS DISCARDED. NO HARM TO THE PATIENT WAS REPORTED AS A RESULT OF THIS ISSUE. NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22549452 ↗MalfunctionMay 21, 2024Break; Break
IT WAS REPORTED THAT THE 3-PIECE MONOFOCAL INTRAOCULAR LENS (IOL) WAS FAULTY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19367338 ↗MalfunctionDec 19, 2023Break; Break
IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS BROKEN. THROUGH FOLLOW UP WE LEARNED THAT THE LENS WAS IMPLANTED, BUT ONCE IN THE PATIENT'S EYE, IT WAS SEEN THAT THE OPTICAL PLATE WAS RUINED. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER IOL OF THE SAME POWER. NO ADDITIONAL INFORMATION WAS RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18361217 ↗MalfunctionAug 8, 2022Material Split, Cut or Torn; Material Split, Cut or Torn
CUSTOMER REPORTED A TORN SENSAR AR40E INTRAOCULAR LENS (IOL). NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15188698 ↗MalfunctionMar 20, 2022Break; Break
WHEN THE INTRAOCULAR LENS IS INSERTED, PINCHING OF THE SECOND OPTIC WAS OBSERVED, PRODUCING ITS RUPTURE. THE INTRAOCULAR LENS WAS REMOVED AND REPLACED BY A THREE-PIECE LENS. NO ADDITIONAL SURGERY OR COMPLICATION WAS PRESENTED. NO FURTHER INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13831435 ↗
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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