SENSAR IOL AR40e (REF AR40E00170)Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 05050474502048), received between Jul 6, 2018 and Jun 26, 2026 — classified as 9 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Break” (14 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryJun 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A THREE PIECE NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS IMPLANTED AND EXPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 25637820 ↗
• MalfunctionMay 7, 2026Break

  IT WAS REPORTED THAT THE NON-PRELOADED INTRAOCULAR LENS (IOL) WAS OPENED BUT NOT IMPLANTED, AS IT WAS FOUND TO BE BROKEN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25113734 ↗
• MalfunctionApr 28, 2026Break

  IT REPORTED THAT NON-PRELOADED MONOFOCAL INTRAOCULAR LENS WAS FULLY INSERTED INTO THE RIGHT EYE DURING A PROCEDURE. DURING THE SAME PROCEDURE, THE LENS WAS REMOVED AND REPLACED DUE TO A BENT HAPTIC. A DIFFERENT LENS, WITH SAME MODEL AND 17.5 DIOPTER WAS IMPLANTED WITHOUT COMPLICATIONS. NO ADDITIONAL MEDICAL INTERVENTIONS, SUCH AS VITRECTOMY, SUTURES, OR INCISION ENLARGEMENT, WERE REQUIRED. THE PATIENT IS FINE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25020959 ↗
• MalfunctionFeb 12, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, INTRAOCULAR LENS (IOL) WAS NOT STABLE AFTER IMPLANTATION. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS DURING THE SAME PROCEDURE. THERE WAS NO PATIENT INJURY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24327447 ↗
• MalfunctionJul 8, 2025Break; Break

  IT WAS REPORTED THAT THE NON-PRELOADED INTRAOCULAR LENS HAPTIC WAS BROKEN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22446480 ↗
• InjuryJun 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE NON-PRELOADED INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S EYE AFTER A FACETOMY SURGERY. THE IOL TURNED INSIDE THE PATIENT'S EYE, PROMPTING THE SURGEON TO REMOVING AND REPLACING THE LENS. THE IOL WAS DISCARDED UPON RETRIEVAL. THROUGH FOLLOW-UP, WE LEARNED THAT THE PATIENT IS FINE AND THE SURGERY PROCEEDED NORMALLY. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 22342669 ↗
• InjuryMay 9, 2025Break; Break

  ACCOUNT REPORTED THAT PATIENT HAD CATARACT PROCEDURE IN WHICH THE INTRAOCULAR LENS (IOL) WAS IMPLANTED. AFTER IOL WAS IMPLANTED THE DOCTOR NOTICED THE HAPTIC WAS KINKED AND HE PROCEEDED TO REMOVE THE LENS DURING THE SAME PROCEDURE. THE ACCOUNT INDICATED THERE WAS A CAPULAR TEAR AND THE PATIENT HAD A VITRECTOMY, SUTURES AND INCISION ENLARGEMENT. THE PATIENT WAS LEFT APHAKIC AND THE PLAN IS TO HAVE A SECONDARY LENS AT A LATER DATE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Bag Tear; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21999010 ↗
• InjuryMay 8, 2025Break; Failure to Fold; Use of Device Problem; Break; Failure to Fold; Use of Device Problem

  THE SURGEON HAD TO REMOVE THE AR40E MODEL INTRAOCULAR LENS (IOL) DURING THE INITIAL PROCEDURE. IT WAS REPORTED THAT THE BACK HAPTIC WAS MOST LIKELY NOT SWEPT TO THE SIDE DUE TO THE TECHNICIAN'S LACK OF EXPERIENCE WITH LOADING THIS PARTICULAR LENS. IT WAS ALSO REPORTED THE TRAILING HAPTIC WAS KINKED. THE IOL WAS NOT FULLY INSERTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE) AND THE LENS WAS CUT OUT. THE INCISION WAS ENLARGED, UNPLANNED SUTURES WERE NEEDED, AND AN UNPLANNED VITRECTOMY WAS PERFORMED. SUTURES WERE USED AS A PROPHYLACTIC MEASURE. THERE WAS NO SERIOUS PATIENT INJURY. PATIENT PROGNOSIS POST-PROCEDURE WAS REPORTED AS APHAKIA. THE DOCTOR ANTICIPATES THE PATIENT WILL DO WELL ONCE THE SECONDARY LENS IS PLACED. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT WAS NOT SAVED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21983038 ↗
• MalfunctionApr 3, 2025Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) TRAILING HAPTIC BROKE IN THE PATIENT'S OPERATIVE EYE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21768901 ↗
• MalfunctionMar 26, 2025Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS DEFECTIVE COMING OUT OF THE INSERTER. THE ISSUE WAS FIRST IDENTIFIED DURING IMPLANTATION. THE LENS WAS INSERTED AND REMOVED DURING THE SAME PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAS FULLY RECOVERED. THE MATERIAL IS NOT AVAILABLE FOR INVESTIGATION. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21704030 ↗
• MalfunctionOct 1, 2024Break; Break

  IT WAS REPORTED THAT A MONOFOCAL INTRAOCULAR LENS (IOL) FOR THE RIGHT EYE OF A PATIENT WAS WASTED/REPLACED AS THE LENS WAS DEFECTIVE/DAMAGED. THE EXTENT OF PATIENT CONTACT IS UNKNOWN/NOT PROVIDED. IT WAS NOTED THAT THE ISSUE WAS NOT DUE TO USE ERROR. IT WAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED/DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20341268 ↗
• InjuryAug 23, 2024Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE SURGEON FOUND THE CAPSULE AND THE SULCUS TO BE UNSTABLE AFTER IMPLANTING THE IOL INTO THE PATIENT'S EYE BECAUSE THERE WAS A KINK AT THE HAPTIC-OPTIC JUNCTION. THIS CAUSED THE LENS TO FLOAT. THE INTRAOCULAR LENS WAS REMOVED AND THE PATIENT WAS LEFT APHAKIC. THERE WAS NO DELAY IN TREATMENT OR OTHER INTERVENTIONS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 20051864 ↗
• MalfunctionJun 21, 2024Break; Break

  IT WAS REPORTED THAT A SENSAR MONOFOCAL INTRAOCULAR LENS (IOL) WAS BENT DURING MANIPULATION, LENS REMOVED FROM THE PATIENT'S LEFT EYE. IT WAS NOTED THAT HAPTIC WAS BENT AFTER INSERTION TRYING TO MANIPULATE THE LENS INTO PLACE. THERE WAS NO INCISION ENLARGEMENT NEEDED. LENS WAS CUT IN HALF AND REMOVED. BACKUP LENS WAS USED AND INSERTED SUCCESSFULLY. PATIENT OUTCOME/POSTOP AS PLANNED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19589944 ↗
• InjuryDec 27, 2023Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED THAT THE LENS HAPTIC WAS KINKED PERMANENTLY. UPON IMPLANTATION OF NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) INTO THE PATIENT'S EYE. THE PATIENT WAS TEMPORARILY IMPAIRED. THE LENS WAS FULLY INSERTED AND REMOVED DURING THE SAME PROCEDURE. T HERE WAS SUTURES, INCISION ENLARGEMENT AND MEDICATIONS BEING PRESCRIBED TO THE PATIENT. THERE WAS DELAY IN TREATMENT OF 1 HOUR AND NO OTHER INTERVENTIONS PERFORMED. DIRECTIONS FOR USE WERE FOLLOWED. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 18398909 ↗
• MalfunctionJul 20, 2022Break; Inaccurate Delivery; Break; Inaccurate Delivery

  IT WAS REPORTED THAT THE HAPTIC OF THE INTRAOCULAR LENS (IOL) BENT DURING LOADING. THE LENS HAD CONTACTED THE PATIENT'S LEFT EYE; HOWEVER, IT WAS NEVER IMPLANTED. THERE WAS NO PATIENT INJURY REPORTED. NO MEDICAL INTERVENTION WAS REQUIRED. THE PROCEDURE WAS COMPLETED USING ANOTHER IOL OF DIFFERENT MODEL BUT OF SAME DIOPTER. THE PATIENT WAS FINE POST OPERATION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15067137 ↗
• MalfunctionDec 16, 2021Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS FULLY INSERTED INTO PATIENT'S OPERATIVE EYE, HOWEVER, WAS REMOVED DURING THE SAME PROCEDURE AS THE TRAILING HAPTIC WAS BENT. THERE WAS NO OTHER INTERVENTION REQUIRED. THE PROCEDURE WAS COMPLETED USING ANOTHER LENS OF SAME MODEL AND DIOPTER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13016193 ↗
• InjuryJul 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A AR40E INTRAOCULAR LENS (IOL) WAS STUCK INSIDE THE NARROW END OF THE CARTRIDGE AND THE PLUNGER APPEARS TO HAVE DAMAGED THE BOTTOM OF THE CARTRIDGE. THE SUSPECT CARTRIDGE WAS NOT A JOHNSON AND JOHNSON VALIDATED CARTRIDGE WHICH IS APPROVED TO BE USED WITH A JOHNSON AND JOHNSON'S LENS. REPORTEDLY, INCISION WAS ENLARGED DURING SURGERY. PATIENT HAS RECOVERED AND THERE IS NO INDICATION OF ANY INJURY TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8815402 ↗
• InjuryJun 7, 2019Break; Separation Problem; Break; Separation Problem

  IT WAS REPORTED THAT BOTH HAPTICS BROKE INSIDE OF THE PATIENT'S EYE AFTER THE MONOFOCAL INTRAOCULAR LENS (IOL), MODEL AR40E, 17.0 DIOPTER WAS IMPLANTED. THE LENS WAS REMOVED WITH DIFFICULTY AS BOTH HAPTICS WERE DETACHED FROM THE OPTIC. DURING THE SAME PROCEDURE, THE LENS WAS REMOVED, AND THE INCISION WAS ENLARGED. A SECOND LENS OF THE SAME MODEL WAS IMPLANTED. IT WAS INDICATED THAT DUE TO THE BROKEN HAPTICS, THE PATIENT EXPERIENCED HYPHEMA AS THE HAPTIC TOUCHED THE IRIS. REPORTEDLY, THE SURGEON WAS OBLIGATED TO LEAVE A BIT OF OPHTHALMIC VISCOSURGICAL DEVICE (OVD). ON DAY ONE (D1), THE PATIENT WAS REALLY HYPERTONE AT 45 AND THERE WAS CORNEAL EDEMA WHICH THE PATIENT WAS UNDER MEDICATION DIAMOX SIMBRINZA GANFORT. ON DAY THREE, THE PATIENT WAS BETTER, HYPHEMA AND CORNEAL EDEMA HAD REDUCED, AND TONICITY WAS NORMAL. IT WAS INDICATED THAT THE LENS IS AVAILABLE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Corneal Edema; Hyphema; No Code Available

  MAUDE report 8680586 ↗
• InjuryJul 6, 2018Material Opacification; Material Opacification

  IT WAS REPORTED THAT AN AR40E 17.0 DIOPTER INTRAOCULAR LENS WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2009. POST-OPERATIVELY, THE PATIENT'S VISION GOT WORSE, THE LENS OPACIFIED, AND THE PATIENT'S INTRAOCULAR PRESSURE (IOP) WAS 12 MMHG. IT WAS ALSO REPORTED THAT THE PATIENT HAD CORNEAL ULCER 2-3 YEARS AGO. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Corneal Ulcer; Visual Impairment

  MAUDE report 7665819 ↗