SENSAR IOL AR40e (REF AR40E00260)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
- 7
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05050474502222), received between Aug 25, 2016 and Nov 6, 2025 — classified as 1 injury, 6 malfunctions.
The most frequently reported specific device problem is “Break” (7 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
- Break7
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Capsular Bag Tear1
- No Information1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 6, 2025Break; Break
IT WAS REPORTED THAT A NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) HAD A BENT TRAILING HAPTIC. THE LENS WAS REMOVED FROM PATIENT'S EYE AND NOT USED. PATIENT STATUS IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23490366 ↗MalfunctionFeb 5, 2025Break; Break
IT WAS REPORTED THAT THE NON-PRELOADED INTRAOCULAR LENS (IOL) WAS IMPLANTED IN A PATIENT BUT EXHIBITED HAPTIC MEMORY. AS A RESULT, THE LENS WAS EXPLANTED. THROUGH FOLLOW-UP, WE LEARNED THAT THE LENS WAS REMOVED DURING THE SAME PROCEDURE. A REPLACEMENT IOL WAS SUCCESSFULLY IMPLANTED. ACCOUNT INDICATED THAT WHEN THE LENS CAME OUT OF THE CARTRIDGE DURING THE SURGICAL PROCEDURE, THE HAPTIC WAS BENT AND DID NOT RETURN TO ITS NORMAL POSITION, WHICH IS SUPPOSED TO BE LIKE AN 'S', AND IT REMAINED CROOKED. THE IOL ENDED UP OUT OF POSITION AND NEEDED TO BE REMOVED FROM THE PATIENT'S EYE. THE EMERALD CARTRIDGE AND OPHTHALMIC VISCOSURGICAL DEVICE (OVD) WERE ALSO USED DURING THE PROCEDURE. THE PATIENT IS WELL. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21318111 ↗MalfunctionJun 17, 2024Break; Break
IT IS REPORTED THAT THE NON-PRELOADED MONOFOCAL INTRAOCULAR LENS GOT A HAPTIC DAMAGED (BENT) AFTER DELIVERY DURING MANIPULATION WHEN TRYING TO PLACE IT INTO THE EYE. LENS WAS REMOVED AND REPLACED BY ANOTHER COMPANY MANUFACTURED LENS. THE PATIENT¿S OUTCOME IS FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19554941 ↗MalfunctionMar 13, 2023Break; Break
IT WAS REPORTED THAT THE LENS WAS DEFECTIVE. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16535014 ↗MalfunctionOct 29, 2022Break; Break
IT WAS REPORTED THAT THE HAPTIC OF THE INTRAOCULAR LENS (IOL) SNAPPED/ CRIMPED UPON INSERTION INTO PATIENT'S OPERATIVE EYE. THE CARTRIDGE TIP MADE CONTACT WITH THE EYE. THE LENS WAS INSERTED AND REMOVED DURING THE SAME PROCEDURE. THE ORIGINAL LENS WAS DISCARDED. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15696311 ↗MalfunctionJun 19, 2018Break; Break
IT WAS REPORTED THAT THE INTRAOCULAR LENS (MODEL AR40E) WAS DEFECTIVE AND THE HAPTIC WAS BROKEN. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Information
MAUDE report 7613424 ↗InjuryAug 25, 2016Break; Break
IT WAS REPORTED THAT DURING THE IOL (INTRAOCULAR LENS) IMPLANT, THERE WAS DETACHMENT OF THE FIRST HAPTIC FROM THE OPTIC ZONE. IT HAS CAUSED A POSTERIOR CAPSULE BREAK. THE PRODUCT IS AVAILABLE FOR INVESTIGATION. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Capsular Bag Tear
MAUDE report 5905255 ↗
Other intraocular lens devices
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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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