SENSAR IOL AR40E (REF AR40E00020)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 05050474501843), received between Jan 7, 2019 and Sep 18, 2026 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Break; Difficult to Insert

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50826402 ↗
• MalfunctionJun 12, 2026Break

  IT WAS REPORTED THAT DURING IMPLANTATION, THE PHYSICIAN OBSERVED A BENT HAPTIC WITHIN THE CARTRIDGE, AND THE LENS WAS REMOVED THROUGH THE INCISION. A NEW LENS OF THE SAME MODEL AND DIOPTER WAS IMPLANTED IN ITS PLACE. THE CARTRIDGE TIP CAME INTO CONTACT WITH THE PATIENT¿S RIGHT EYE. NO INCISION ENLARGEMENT OR UNPLANNED VITRECTOMY WAS REQUIRED; HOWEVER, THE PROCEDURE WAS DELAYED BY APPROXIMATELY 20 MINUTES. NO MEDICATIONS OUTSIDE THE STANDARD OF CARE WERE PRESCRIBED. THE PATIENT FULLY RECOVERED WITH NO IMPACT ON ACTIVITIES OF DAILY LIVING. THE DIRECTIONS FOR USE WERE FOLLOWED. THE COMPLAINT DEVICE WAS NOT AVAILABLE FOR RETURN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25494288 ↗
• MalfunctionMay 29, 2026Break

  IT WAS REPORTED THAT A THREE PIECE NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS FOUND TO HAVE A BENT HAPTIC DURING HANDLING PRIOR TO INSERTION, RENDERING THE DEVICE UNUSABLE. THE PRODUCT WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25340828 ↗
• MalfunctionMay 15, 2026Break

  IT WAS REPORTED THAT A MONOFOCAL INTRAOCULAR LENS (IOL) WAS DEFECTIVE. THE IMPLANT WAS PARTIALLY INSERTED AND SUBSEQUENTLY REMOVED DURING THE SAME PROCEDURE. IT WAS ALSO NOTED THAT THE LENS WAS INSERTED AND REMOVED DURING THE SAME PROCEDURE. THE PRODUCT WAS DISCARDED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25194174 ↗
• MalfunctionNov 7, 2025Break; Break

  IT WAS REPORTED THAT A MONOFOCAL INTRAOCULAR LENS (IOL) WAS DAMAGED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23498987 ↗
• MalfunctionOct 15, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED BY THE CUSTOMER THAT DURING A SURGICAL PROCEDURE, THE UPPER HAPTIC OF A NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) BROKE OFF DURING INSERTION. THE SURGEON OBSERVED THAT THE LEADING HAPTIC WAS BROKEN DURING THE INJECTION OF THE LENS AND ATTRIBUTED THE ISSUE TO THE HAPTIC GETTING CAUGHT IN THE CARTRIDGE. A NEW LENS WITH SAME MODEL AND DIOPTER WAS OPENED AND IMPLANTED WITHOUT INCIDENT. THERE WAS NO PATIENT INJURY REPORTED. IT WAS NOTED THAT A 0.2 ML VISCOELASTIC DEVICE WAS USED AT ROOM TEMPERATURE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23297560 ↗
• MalfunctionJun 10, 2025Break; Break

  IT WAS REPORTED THAT THE LENS BROKE IN HALF UPON INSERTION. ADDITIONAL INFORMATION REVEALED THAT THE LENS WAS FULLY INSERTED AND THEN REMOVED AND REPLACED WITH ANOTHER J&J LENS. THE PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22180573 ↗
• MalfunctionNov 19, 2024Scratched Material; Material Split, Cut or Torn; Scratched Material; Material Split, Cut or Torn

  THE SURGEON REPORTED THAT THE LENS IS TORN OR SCRATCHED. IT WAS FULLY INSERTED, AND THE ISSUE WAS NOTICED AFTER IMPLANTATION. THE PATIENT EXPERIENCED TEMPORARY IMPAIRMENT. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20718321 ↗
• InjuryAug 21, 2024Ejection Problem; Ejection Problem

  IT WAS REPORTED THE PATIENT WAS GETTING A "PIGGY BACK" LENS PLACED IN THE SULCUS OF HIS EYE. WHEN THE LENS WAS INSERTED INTO THE EYE IT FLIPPED UPSIDE DOWN. IT WAS DECIDED THAT WE WOULD REMOVE THE LENS AND REPLACE IT, RATHER THAN TRY TO FLIP IT. MIOSTAT WAS USED TO REDUCE PUPIL SIZE. THE PATIENT IS DOING WELL. NO INJURY OR ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20022435 ↗
• MalfunctionJul 23, 2024Break; Break

  IT WAS REPORTED THAT THE LEADING HAPTIC OF INTRAOCULAR LENS (IOL) WAS BENT AND NOTED AFTER IMPLANTATION, SO IT WAS REMOVED AND A NEW IOL WAS INJECTED INTO THE EYE. ADDITIONAL INFORMATION SUGGESTS THAT THE LENS WAS REPLACED WITH SAME MODEL AND DIOPTER IOL . THE PATIENT STATUS IS DOING GOOD. NO INJURY AND MEDICAL INTERVENTION REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19811414 ↗
• MalfunctionAug 23, 2023Break; Break

  IT WAS REPORTED THAT THE NON-PRELOADED INTRAOCULAR LENS (IOL) HAPTIC WAS KINKED AFTER IOL INSERTION INTO THE PATIENT'S OPERATIVE EYE. THERE WERE NO COMPLICATIONS NOTED. LENS WAS FULLY INSERTED. ADDITIONAL INFORMATION RECEIVED STATED THAT THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS DURING THE SAME PROCEDURE. THERE WAS NO REPORTED INJURY TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17608522 ↗
• MalfunctionMar 27, 2023Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS FOUND SLIGHTLY BENT AFTER INSERTING INTO THE PATIENT'S OPERATIVE EYE. ACCOUNT INDICATED THAT THERE WERE NO COMPLICATIONS. IT IS UNKNOWN IF THE IOL REMAINS IMPLANTED OR IF IT WAS REMOVED AND REPLACED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16624514 ↗
• MalfunctionFeb 2, 2023Break; Break

  IT WAS REPORTED THERE WAS AN ABNORMAL STRUCTURE AT THE PERIPHERY OF THE INTRAOCULAR LENS (IOL) OPTICS THAT COULD NOT BE ADJUSTED. IT WAS SUSPECTED TO BE SURFACE DEFECTS IN THE OPTICS SURFACE. THE LENS WAS FULLY INSERTED INTO THE PATIENT'S EYE AND REMAINS IMPLANTED. THERE WAS NO DELAY IN TREATMENT OR OTHER INTERVENTIONS INDICATED. REPORTEDLY, THERE WAS NO INJURY AND THE PATIENT'S VISION HAS IMPROVED POST-OP. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16285063 ↗
• MalfunctionJul 28, 2022Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS LOADED AND INSERTED INTRAOCULARLY WHEN IT WAS NOTED THAT THE LENS WAS DEFECTIVE; THEREFORE, IT WAS REMOVED DURING THE SAME PROCEDURE. ACCOUNT INDICATED THAT THE INCISION WAS ENLARGED FOR IOL REMOVAL. THE LENS WAS DESTROYED AND DISCARDED. THERE WAS NO INFORMATION PROVIDED REGARDING IF THE IOL WAS REPLACED. THERE WAS NO PATIENT INJURY REPORTED. PATIENT OUTCOME WAS NOT PROVIDED. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 15126321 ↗
• MalfunctionJan 7, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE HAPTIC OF AN AR40E 2.0 DIOPTER LENS WAS BENT. IT IS UNKNOWN WHEN THIS OCCURRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8220954 ↗