SENSAR IOL AR40e (REF AR40E00090)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
- 5
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474501911), received between Sep 12, 2016 and Aug 13, 2026 — classified as 1 injury, 4 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
- Detachment of Device or Device Component1
- Scratched Material1
- Torn Material1
Patient problems
- No Consequences Or Impact To Patient2
- No Clinical Signs, Symptoms or Conditions1
- No Code Available1
- No Patient Involvement1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 13, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50244329 ↗MalfunctionFeb 18, 2019Break; Break
IT WAS REPORTED THAT THE HAPTIC OF THE AR40E MONOFOCAL IOL (INTRAOCULAR LENS) WAS FOUND BROKEN AFTER IMPLANTATION. AS A RESULT, THE LENS WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE. REPORTEDLY, THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8346851 ↗InjuryJan 5, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING IMPLANT OF A MODEL AR40E SENSAR MONOFOCAL IOL (INTRAOCULAR LENS) THE TRAILING HAPTIC DETACHED. FURTHER, WHILE GRIPPING THE LENS OPTIC IN THE EYE, THE HAPTIC DROPPED OUT OF THE OPTICAL SECTION. THE LENS WAS REMOVED AND REPLACED. DURING LENS REMOVAL, THE LENS TOUCHED THE CORNEA. THE CORNEA WAS SCRATCHED AND CLOUDY. IF THE CORNEAL OPACITY DOES NOT HEAL, A CORNEAL TRANSPLANT WILL BE CONSIDERED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE BACK-UP LENS. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Code Available
MAUDE report 8220602 ↗MalfunctionApr 9, 2018Torn Material; Torn Material
IT WAS REPORTED THAT THE OPTIC OF THE INTRAOCULAR LENS WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT AND/OR INJURY REPORTED. BASED ON FOLLOW UP INFORMATION, THE LENS OPTIC WAS TORN UPON OPENING THE PACKAGE. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 7410190 ↗MalfunctionSep 12, 2016Scratched Material; Scratched Material
IT WAS REPORTED THAT ONE DAY POST OP THE SURGEON OBSERVED SCRATCH MARKS OR FORCEPS MARKS ON THE TWO SIDES OF THE OPTIC OF AN IMPLANTED INTRAOCULAR LENS (IOL). NO VISUAL PROBLEM AND NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 5945020 ↗
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- 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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