SENSAR IOL AR40E (REF AR40E00030)Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 05050474501850), received between Nov 17, 2016 and Jun 17, 2026 — classified as 9 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Break” (13 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2026Material Fragmentation

  IT WAS REPORTED THAT DURING SURGERY, THE MONOFOCAL STANDALONE INTRAOCULAR LENS (IOL) HAPTIC BROKE AND REQUIRED REMOVAL AFTER ONE HAPTIC BROKE OFF AND BECAME CAUGHT IN THE INJECTOR. ACCOUNT INDICATED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A BACK UP IOL NO INJURY WAS REPORTED , AND NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25540383 ↗
• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE CUSTOMER THAT A PATIENT DEVELOPED TOXIC ANTERIOR SEGMENT SYNDROME FOLLOWING IMPLANTATION OF A NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), MODEL AR40E. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 23651235 ↗
• InjuryNov 13, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A NON PRELOADED, MONOFOCAL INTRAOCULAR LENS (IOL) WITH A DIOPTER OF +3.0D+3.0D WAS IMPLANTED IN THE PATIENT¿S RIGHT EYE. DURING A POST OPERATIVE EXAMINATION THE LENS WAS OBSERVED TO BE DISPLACED AND DECENTERED DUE TO ONE HAPTIC FAILING TO HOLD. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS OF THE SAME MODEL AND DIOPTER (+3.0D+3.0D). THERE WAS NO RECENT EYE TRAUMA OR HISTORY OF CONDITIONS KNOWN TO WEAKEN THE NATURAL LENS SUPPORT. THERE WAS ALSO NO INDICATION OF RESIDUAL VISCOELASTIC MATERIAL REMAINING AFTER THE ORIGINAL SURGERY THAT MIGHT HAVE CAUSED EARLY MOVEMENT, AND NO SURGICAL MANEUVERS OUTSIDE THE NORMAL STANDARD OF PRACTICE WERE REQUIRED TO DELIVER OR POSITION THE ORIGINAL LENS. THERE WAS NO SURGICAL DELAY AND NO COMPLICATIONS SUCH AS INCISION ENLARGEMENT, SUTURES, OR VITRECTOMY REPORTED. NO ADDITIONAL MEDICAL ATTENTION OR MEDICATION BEYOND THE STANDARD OF CARE WAS REQUIRED, AND THE PATIENT¿S DAILY ACTIVITIES WERE NOT AFFECTED. THE PATIENT HAS FULLY RECOVERED, AND THE REPLACEMENT LENS WAS PROPERLY POSITIONED ON POST OP DAY 1. THE EXPLANTED LENS WAS DISCARDED AND WILL NOT BE RETURNED. DIRECTIONS FOR USE WERE FOLLOWED. DURING DEVICE PREPARATION A BA

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

  MAUDE report 23547898 ↗
• InjuryJul 11, 2025Break; Break

  IT WAS REPORTED BY A SURGEON THAT DURING THE IMPLANTATION OF A MONOFOCAL INTRAOCULAR LENS (IOL) THE HAPTIC KINKED AFTER THE LENS WAS INJECTED INTO THE EYE RESULTING IN THE LENS NOT BEING CENTERED, LEADING TO AN EXPLANT. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 22484896 ↗
• InjuryDec 3, 2024Adverse 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 EXPLANTED FROM PATIENT'S LEFT EYE AS THE PATIENT COMPLAINED OF DIFFICULTY IN READING. THE LENS WAS EXPLANTED AND REPLACED WITH A NON JNJ LENS IN A SECONDARY PROCEDURE. THERE WAS NO PATIENT INJURY. THERE WAS NO PRODUCT ISSUE OR PATIENT ISSUE. THERE WAS NO USE ERROR. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 20838601 ↗
• MalfunctionNov 3, 2024Break; Break

  THE NON PRE-LOADED AR40E MODEL INTRAOCULAR LENS (IOL) HAPTICS BROKE WHILE TRYING TO LOAD. EXTENT OF PATIENT CONTACT WITH THE IOL IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20595597 ↗
• MalfunctionNov 3, 2024Break; Break

  THE NON-PRE-LOADED AR40E MODEL INTRAOCULAR LENS (IOL) HAPTICS BROKE WHILE TRYING TO LOAD. EXTENT OF PATIENT CONTACT WITH THE IOL IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20595579 ↗
• MalfunctionDec 22, 2023Break; Break

  IT IS REPORTED THAT NON PRELOADED INTRAOCULAR LENS IMPLANTED A 3.0 DIOPTER ON 12-6-23. UPON DELIVERY IN THE EYE, SURGEON NOTICED THE HAPTICS WERE BENT AND SHE EXPLANTED THAT LENS. A SECOND IOL WAS LOADED BUT SHE NOTICED THAT THE HAPTICS WERE BENT AS WELL. THIS SECOND IOL HAD NOT PATIENT CONTACT. A THIRD IOL, AR40E 3-PIECE, WAS LOADED AND SUCCESSFULLY IMPLANTED. THE INCISION WAS ENLARGED BUT ONLY TO ACCOMMODATE THE 2.85 INCISION NEEDED FOR THE AR40E VERSUS THE 2.4MM PHACO INCISION. THE PATIENT WAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 18385043 ↗
• MalfunctionOct 21, 2022Break; Break

  IT WAS REPORTED THAT DURING IMPLANT, HAPTIC BROKE AND WAS REPLACED WITH NEW IOL. THERE WAS NO IMPACT TO THE PATIENT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15656022 ↗
• MalfunctionAug 24, 2022Break; Failure to Fold; Break; Failure to Fold

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS DEFECTIVE AND THAT THE HAPTIC COULD NOT BE FOLDED AND THE LENS COULD NOT BE IMPLANTED. THROUGH FOLLOW UP IT WAS LEARNED THAT THERE WAS PATIENT CONTACT WITH THE LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15280919 ↗
• MalfunctionAug 24, 2022Break; Failure to Fold; Break; Failure to Fold

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS DEFECTIVE AND THAT THE HAPTIC COULD NOT BE FOLDED AND THE LENS COULD NOT BE IMPLANTED. THROUGH FOLLOW UP IT WAS LEARNED THAT THERE WAS PATIENT CONTACT WITH THE LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15280901 ↗
• MalfunctionAug 8, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  CUSTOMER REPORTED A TORN SENSAR AR40E INTRAOCULAR LENS (IOL). NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15188931 ↗
• MalfunctionJul 1, 2022Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAD A HAPTIC DAMAGE, THEREFORE, THE LENS WAS NOT IMPLANTED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14892868 ↗
• MalfunctionApr 5, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT THE SURGEON IMPLANTED AN INTRAOCULAR LENS (IOL), BUT THE LENS WOULD NOT UNFOLD. THE LENS WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE WITH ANOTHER JOHNSON & JOHNSON (SAME MODEL AND DIOPTER). IN THE SECOND ATTEMPT, THE REPLACEMENT LENS FAILED AS THE LENS DID NOT UNFOLD EITHER. THE SURGEON HAD TO REVERT TO THE BIOMETRY AND SUCCESSFULLY IMPLANTED A 5.00D PCB00 LENS WITHOUT ANY PROBLEMS. THE PATIENT FULLY RECOVERED. NO OTHER MEDICAL OR SURGICAL INTERVENTIONS REPORTED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR THE FIRST LENS IMPLANTED. A SEPARATE REPORT WILL BE SUBMITTED FOR THE OTHER LENS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14014662 ↗
• MalfunctionApr 5, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT THE SURGEON IMPLANTED AN INTRAOCULAR LENS (IOL), BUT THE LENS WOULD NOT UNFOLD. THE LENS WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE WITH ANOTHER JOHNSON & JOHNSON (SAME MODEL AND DIOPTER). IN THE SECOND ATTEMPT, THE REPLACEMENT LENS FAILED AS THE LENS DID NOT UNFOLD EITHER. THE SURGEON HAD TO REVERT TO THE BIOMETRY AND SUCCESSFULLY IMPLANTED A 5.00D PCB00 LENS WITHOUT ANY PROBLEMS. THE PATIENT FULLY RECOVERED. NO OTHER MEDICAL OR SURGICAL INTERVENTIONS REPORTED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR THE SECOND LENS IMPLANTED. A SEPARATE REPORT WILL BE SUBMITTED FOR THE FIRST LENS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14014591 ↗
• MalfunctionFeb 23, 2022Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD A LENS DAMAGED AND IT WAS IMPLANTED AND REMOVED. THROUGH FOLLOW-UP IT, WAS LEARNT THAT THE HAPTIC WAS BROKEN. A NEW LENS WAS IMPLANTED AS A REPLACEMENT. THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13582788 ↗
• MalfunctionSep 17, 2021Break; Break

  IT WAS REPORTED THAT HAPTIC WAS BROKEN INTO THE PATIENT EYE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12492676 ↗
• MalfunctionAug 5, 2021Break; Break

  THE CUSTOMER REPORTED THAT WHEN INJECTING THE INTRAOCULAR LENS (IOL) IN THE PATIENT, THE DOCTOR NOTICED THE LENS HAD ONE OF THE HANDLES LOOSE FROM THE OPTIC ZONE. LENS INSERTED AND REMOVED DURING THE SAME PROCEDURE. LENS WAS FULLY INSERTED. NO PATIENT INJURY REPORTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12282252 ↗
• InjuryJan 14, 2021Break; Break

  IT WAS REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) WAS IMPLANTED, THE SURGEON FOUND THAT HAPTIC WAS BROKEN IN THE PATIENT¿S EYE. THE INCISION WAS ENLARGED AND THE DAMAGED IOL WITH BROKEN HAPTIC WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE. IT WAS ALSO REPORTED THAT SUTURES WERE REQUIRED AND MEDICATION WAS PRESCRIBED TO THE PATIENT. THERE WAS NO VITRECTOMY PERFORMED. THE PATIENT WAS REPORTED TO BE TEMPORARILY IMPAIRED. THE EXPLANTED LENS WAS DISCARDED. NO ADDITIONAL INFORMATION PROVIDED.

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

  MAUDE report 11168729 ↗
• InjuryDec 10, 2020Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT'S LEFT EYE (OS) DUE TO PATIENT SEEING SHADOWS. THE INCISION WAS ENLARGED AND SUTURES WERE USED. A REPLACEMENT LENS OF THE SAME MODEL AND DIOPTER WAS USED. IT WAS INDICATED THAT THE PATIENT IS FINE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 10988896 ↗
• MalfunctionSep 8, 2020Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) COULD NOT UNFOLD BY ITSELF. THE PATIENT UNDERWENT CATARACT SURGERY AND LENS IMPLANTATION DUE TO HIGH MYOPIA AND SENILE CATARACT. DURING IOL IMPLANTATION, ONE SIDE OF THE HAPTIC COULD NOT BE UNFOLDED. THE LENS WAS REMOVED AND REPLACED WITH A NEW ONE AND THE IMPLANT WAS COMPLETED SMOOTHLY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10505246 ↗
• InjuryAug 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AR40E 3.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE) ON (B)(6) 2019. IOL WAS EXPLANTED (B)(6) 2019 DUE TO COMPLAINT OF NON-SPECIFIC DYSPHOTOPSIA. IT WAS REPORTED THERE WAS NO INCISION ENLARGEMENT, OUTCOME DOES NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE, AND THE PATIENT HAS RECOVERED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available

  MAUDE report 8910174 ↗
• MalfunctionApr 9, 2019Break; Break

  IT WAS REPORTED THAT THE AR40E +3.0 DIOPTER MONOFOCAL INTRAOCULAR LENS (IOL) WAS INSERTED AND REMOVED WITHIN THE SAME PROCEDURE DUE TO THE LEADING HAPTIC BEING BROKEN OFF. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER LENS OF THE SAME MODEL AND DIOPTER SIZE. NO INCISION ENLARGEMENT, NO VITRECTOMY WAS PERFORMED AND NO SUTURES WERE USED. REPORTEDLY, THE PATIENT IS DOING FINE. THE ACCOUNT COMMENTED THAT THE IOL WAS DISCARDED AT THE SURGERY CENTER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8494613 ↗
• InjuryMar 21, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT REPORTED THAT AFTER IMPLANTATION OF AN AR40E INTRAOCULAR LENS (IOL) INTO HER RIGHT EYE ON (B)(6) 2016, SHE EXPERIENCED ISSUES WITH HALOS AND GLARE. ALSO THAT SHE HAD LASER SURGERY DONE. THROUGH FOLLOW-UP IT WAS LEARNED THAT THE PATIENT ALSO HAS AN AR40E IOL IMPLANTED IN THE LEFT EYE. THE PATIENT IS EXPERIENCING GLARES IN THE RIGHT EYE AND HALOS FOR BOTH EYES. SHE STATED THAT HER RETINA SPECIALIST TOLD HER THAT HER RETINA IS THIN AND THAT SHE HAS POSITIVE DYSPHOTOPSIA. SHE REMEMBERS THAT HER PHYSICIAN SAID THAT SHE MAY NEED A YAG PROCEDURE LATER ON. THE PATIENT CANNOT DRIVE BECAUSE OF THE DYSPHOTOPSIA BUT SHE CAN READ WITH CONTACT LENSES. WITHOUT THE CONTACT LENSES SHE CANNOT SEE ANYTHING AND IS VERY DISAPPOINTED. THIS EVENT IS REPORTABLE AT THIS TIME FOR THE LENS IMPLANTED IN THE RIGHT EYE.

  Patient problems: Halo; No Code Available

  MAUDE report 6421671 ↗
• InjuryNov 17, 2016Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT HAD AN IRIS PROLAPSE. THE LENS WAS ORIGINALLY IMPLANTED IN (B)(6) (YEAR NOT PROVIDED). THE LENS WAS UPSIDE DOWN AND PIGGY BACKED TO ANOTHER LENS. LENS WAS TOO RIGID AND SCISSORS WERE TOO LARGE TO GET THE LENS OUT. SUTURES WERE REQUIRED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 6108384 ↗