SENSAR IOL AR40E (REF AR40E00050)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05050474501874), received between Aug 31, 2017 and Feb 2, 2026 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 2, 2026Break

  IT WAS REPORTED THAT DURING A PROCEDURE THE INTRAOCULAR LENS (IOL) WAS FOUND WITH A BROKEN HAPTIC AFTER IMPLANTATION IN THE PATIENT'S RIGHT EYE. THE IOL WAS SUBSEQUENTLY REMOVED. THE PATIENT DID NOT EXPERIENCE ANY INJURY, AND NO FURTHER MEDICAL OR SURGICAL INTERVENTION WAS NECESSARY. THE PATIENT WAS DESCRIBED AS BEING IN GOOD CONDITION. NO MATERIAL IS AVAILABLE FOR INVESTIGATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24242476 ↗
• InjuryNov 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RIGHT EYE MANUFACTURER REPORT NUMBER 3012236936-2025-0003025 IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S RIGHT EYE. AT THE PATIENT¿S FOLLOW-UP VISIT THE DOCTOR DETERMINED HYPEROPIC ERROR. THE SYMPTOMS WERE REPORTED AS AFFECTING THE PATIENT ABILITY TO PERFORM ONE OR MORE DAILY ACTIVITIES. THE IOL IS SIMPLY NOT THE BEST DIOPTER FOR THE PATIENT. THE IOL WAS EXPLANTED AND REPLACED WITH ANOTHER JOHNSON AND JOHNSON LENS MODEL AR40E 7.5 DIOPTER. THERE WERE NO COMPLICATIONS SUCH AS A CAPSULE TEAR, VITRECTOMY OR SUTURES. THE PATIENT IS DOING WELL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Halo; Visual Disturbances; Visual Impairment

  MAUDE report 23612813 ↗
• InjuryJan 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FULLY INSERTED INTRAOCULAR LENS (IOL) WAS REMOVED AND REPLACED FROM A PATIENT'S LEFT EYE AS DOCTOR HAD TO DO VITRECTOMY AND SWITCH TO A DIFFERENT, A NON-JOHNSON AND JOHNSON LENS. A ONE-HOUR DELAY WAS DUE TO THE UNPLANNED VITRECTOMY, SUTURES, AND IMPLANT OF REPLACEMENT IOL. THERE WAS NO MEDICATION PRESCRIBED. THE PATIENT OUTCOME IS UNKNOWN. THE SUSPECT IOL WAS DISCARDED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16269658 ↗
• MalfunctionDec 9, 2022Inaccurate Delivery; Inaccurate Delivery

  IT WAS REPORTED THAT WHILE IMPLANTING THE INTRAOCULAR LENS (IOL), THE LENS GOT LOADED AND WAS ADVANCING. THE LEADING HAPTIC AND PART OF THE LENS WENT IN; HOWEVER, WHEN THE SURGEON REMOVED THE INJECTOR HALF OF THE LENS CAME OUT. THE SURGEON TRIED TO PUSH IT IN WITH KUGHLEN HOOK, BUT IT DID NOT WORK. THEN A BACK UP IOL WAS REQUESTED. THERE WAS A DELAY OF 5 TO 10 MINUTES AND THE INCISION WAS ENLARGED. PATIENT INDICATED THAT DAILY ACTIVITIES ARE SIGNIFICANTLY AFFECTED AS IT IS HARD TO READ. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15953321 ↗
• MalfunctionApr 7, 2021Break; Break

  IT WAS REPORTED THAT A CUSTOMER HAD A PROBLEM WITH 2 AR40E INTRAOCULAR LENS (IOL) TODAY DURING A CASE. THE HAPTIC BROKE OFF DURING INSERTION OF EACH LENS. THE STAFF DID SAVE THE PIECES OF LENS FROM THE CASE. FOLLOW-UP NOTED THAT THE PATIENT IS DOING OKAY. A DCB00 5.0D IOL WAS IMPLANTED AS BACK-UP IOL. IT WAS LEARNED THAT HOW THE EVENT OCCURRED WAS AS THE LENS WAS LOADED IN THE UNFOLDER, WITH HAPTICS INTACT. WHEN FOLDING THE WINGS, IT SEEMED TO BEVEL, INSTEAD OF FOLDING LIKE A "TACO". BUT IT WAS NOTED THAT THE HAPTIC WAS NOT VISIBLY DETACHED. IT WAS ALSO CONFIRMED THAT THERE WAS PATIENT CONTACT. NO OTHER INFORMATION WAS PROVIDED. THIS MDR REPORT PERTAINS TO ONE OF THE SUSPECT AR40E IOL. A SEPARATE REPORT WILL BE SUBMITTED TO CAPTURE THE OTHER SUSPECT AR40E IOL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11627996 ↗
• MalfunctionApr 7, 2021Break; Break

  IT WAS REPORTED THAT A CUSTOMER HAD A PROBLEM WITH 2 AR40E INTRAOCULAR LENS (IOL) TODAY DURING A CASE. THE HAPTIC BROKE OFF DURING INSERTION OF EACH LENS. THE STAFF DID SAVE THE PIECES OF LENS FROM THE CASE. FOLLOW-UP NOTED THAT THE PATIENT IS DOING OKAY. A DCB00 5.0D IOL WAS IMPLANTED AS BACK-UP IOL. IT WAS LEARNED THAT HOW THE EVENT OCCURRED WAS AS THE LENS WAS LOADED IN THE UNFOLDER, WITH HAPTICS INTACT. WHEN FOLDING THE WINGS, IT SEEMED TO BEVEL, INSTEAD OF FOLDING LIKE A "TACO". BUT IT WAS NOTED THAT THE HAPTIC WAS NOT VISIBLY DETACHED. IT WAS ALSO CONFIRMED THAT THERE WAS PATIENT CONTACT. NO OTHER INFORMATION WAS PROVIDED. THIS MDR REPORT PERTAINS TO ONE OF THE SUSPECT AR40E IOL. A SEPARATE REPORT WILL BE SUBMITTED TO CAPTURE THE OTHER SUSPECT AR40E IOL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11627916 ↗
• InjuryAug 31, 2017Scratched Material; Scratched Material

  IT WAS REPORTED AN AR40E 5.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED ON (B)(6) 2017. THE PATIENT COMPLAINED OF HALOS RIGHT AFTER SURGERY, AND DURING A POST-OPERATIVE EXAMINATION, SEVERAL SCRATCHES WERE OBSERVED ON THE LENS IN THE PATIENT''S EYE. AN IOL REPLACEMENT WILL BE ARRANGED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 6836727 ↗