SENSAR IOL AR40e (REF AR40E00130)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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474501966), received between Dec 4, 2019 and Dec 5, 2019 — classified as 1 injury, 1 malfunction.
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.
Most reported problems
Device problems
- Break2
Patient problems
- No Code Available2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 5, 2019Break; Break
IT WAS REPORTED THAT WHILE ATTEMPTING TO INSERT AN AR40E, 13.0 DIOPTER INTRAOCULAR LENS (IOL) INTO THE PATIENT¿S RIGHT EYE, IT WAS NOTED TO HAVE A BENT/BROKEN HAPTIC. THERE WAS PATIENT CONTACT HOWEVER THE IOL DID NOT REMAIN IMPLANTED. THE INCISION WAS ENLARGED, AND THE DAMAGED IOL WAS REMOVED FROM THE EYE. THE PATIENT RECOVERED, AND THE OUTCOME DOES NOT INTERFERE WITH THE PATIENT¿S DAILY LIFE. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Code Available
MAUDE report 9414671 ↗InjuryDec 4, 2019Break; Break
IT WAS REPORTED THAT LENS HAD BENT/BROKEN HAPTIC. REPORTEDLY THE HAPTIC BROKE AND WENT INTO VITREOUS. LENS WAS REMOVED AND REPLACED IN SAME SURGICAL PROCEDURE. INCISION WAS ENLARGED DURING THIS PROCEDURE. PATIENT HAS RECOVERED. NO FURTHER INFORMATION PROVIDED.
Patient problems: No Code Available
MAUDE report 9407789 ↗
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