SENSAR IOL AR40e (REF AR40E00195)Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 05050474502093), received between Nov 18, 2016 and Feb 13, 2026 — classified as 8 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Break” (25 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 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2026Break

  IT WAS REPORTED THAT A MONOFOCAL INTRAOCULAR LENS (IOL) WAS REPORTED AS DEFECTIVE DUE TO A BROKEN HAPTIC IDENTIFIED DURING A SURGICAL PROCEDURE. THE LENS HAD BEEN FULLY INSERTED INTO THE PATIENT¿S LEFT EYE BEFORE THE DEFECT WAS DISCOVERED. AFTER THE ISSUE WAS IDENTIFIED, THE LENS WAS REMOVED AND REPLACED WITH A ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND DIOPTER). NO PATIENT INJURY OR SURGICAL COMPLICATIONS WERE REPORTED, AND THE PATIENT DID NOT REMAIN APHAKIC. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24339180 ↗
• MalfunctionNov 4, 2025Break; Break

  IT WAS REPORTED THAT UPON INSERTION, THE NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) HAPTIC WAS BENT. THERE WAS PATIENT CONTACT, HOWEVER, THE EXTENT OF PATIENT CONTACT IS UNKNOWN. THERE WAS NO INDICATION OF REQUIRED MEDICAL OR SURGICAL INTERVENTION OR PATIENT INJURY. THE PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23469456 ↗
• MalfunctionJul 25, 2025Break; Difficult to Fold, Unfold or Collapse; Break; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT THE STANDALONE 3 PIECE MONOFOCAL INTRAOCULAR LENS (IOL) WAS DISCARDED AS IT DID NOT UNFOLD. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22612474 ↗
• MalfunctionJun 9, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT A NON-PRELOADED MONOFOCAL IOL HAPTIC BROKE OFF IN A PATIENT'S EYE POST-SURGERY. THE SURGEON EXPLANTED THE LENS AND IMPLANTED A NEW NON-J&J LENS ON (B)(6) 2025. POSSIBLE CAUSES FOR THE INCIDENT INCLUDE SUTURE FAILURE OR NON-COMPLIANCE WITH PATIENT INSTRUCTIONS, BUT THE EXACT REASON REMAINS UNCLEAR. THE PATIENT IS CURRENTLY DOING WELL. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22169992 ↗
• MalfunctionJun 7, 2025Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT A NON-PRELOADED LENS WAS LOADED INTO THE EMERALDXL INJECTOR WITH THE AR40 LENS. THERE WAS NO RESISTANCE AND THE TRAILING HAPTIC WAS ENSURED TO BE STICKING OUT OF THE INJECTOR AT THE 7 O'CLOCK POSITION BEFORE PUSHING THE ROD FORWARD (STILL NO RESISTANCE). THE DOCTOR THEN STARTED ADVANCING THE LENS INTO THE PATIENT'S EYE AND NOTICED, BEFORE IT WAS COMPLETELY IMPLANTED, THAT BOTH HAPTICS WERE SEVERED. THE FAULTY AR40 LENS WAS DISCARDED, AND A DCB00 20.0 LENS WAS INSTEAD IMPLANTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22163416 ↗
• MalfunctionMay 1, 2025Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS DEFECTIVE. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21947164 ↗
• MalfunctionApr 17, 2025Break; Break

  IT WAS REPORTED THAT THE HAPTIC OF THE STANDALONE 3 PIECE MONOFOCAL INTRAOCULAR LENS (IOL) WAS DEFECTIVE. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21862196 ↗
• MalfunctionNov 7, 2024Break; Break

  IT WAS INITIALLY REPORTED THAT A DOCTOR IMPLANTED A MONOFOCAL INTRAOCULAR LENS (IOL), MODEL AR40E, 19.5 DIOPTER WHICH THEN WAS REMOVED ON THE SAME DAY AND REPLACED WITH THE SAME LENS MODEL, BUT HIGHER DIOPTER (20.0D). THE DOCTOR INDICATED THAT THERE WAS NOT ANYTHING WRONG WITH THE LENS AND THAT THE DOCTOR DECIDED TO USE A 20.0 DIOPTER AS THAT WOULD BE BETTER FOR THE PATIENT. TROUGH FOLLOW UPS, IT WAS LEARNED THAT THE HAPTIC TORE ON INSERTION INTO THE PATIENT'S LEFT EYE. IT WAS NOTED THAT THERE WAS NO KNOWN INCIDENT WITH THE LENS DURING LOADING, THE LENS WOULD NOT HAVE BEEN LOADED INTO THE CARTRIDGE IF THERE WAS A PROBLEM PRIOR TO THAT. THE CARTRIDGE WAS NOT SAVED POST SURGERY. NO MEDICAL AND/OR SURGICAL INTERVENTIONS REQUIRED. NO PATIENT INJURY REPORTED. THE PATIENT IS FINE AFTER THE REPLACEMENT LENS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20626912 ↗
• MalfunctionJul 15, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THE NON PRE-LOADED AR40E MODEL INTRAOCULAR LENS (IOL) TORE IN THE EMERALD CARTRIDGE. THE IOL WAS IN THE PATIENT'S EYE AND CUT OUT HOWEVER, THERE WAS NO INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY, NO SUTURE(S), AND NO VITRECTOMY. THE SAME PROCEDURE WAS COMPETED SUCCESSFULLY USING A BACKUP LENS WITH THE SAME MODEL AND DIOPTER SIZE, AR40E 19.5 DIOPTER IOL, THAT WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE). PATIENT PROGNOSIS POST-PROCEDURE WAS REPORTED AS STABLE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19746476 ↗
• InjuryJul 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE AR40E MODEL INTRAOCULAR LENS (IOL) HAD PATIENT CONTACT HOWEVER, THE EXTENT OF PATIENT CONTACT IS UNKNOWN. THE INCISION WAS ENLARGED AND VITRECTOMY WAS PERFORMED HOWEVER, THERE WAS NO SERIOUS PATIENT INJURY. IT IS UNKNOWN IF SUTURES WERE REQUIRED. IT IS UNKNOWN WHAT TRIGGERED THE VITRECTOMY. THE EVENT WAS NOT DUE TO A PRODUCT QUALITY ISSUE. HOWEVER, IT IS UNKNOWN IF A PATIENT ISSUE CONTRIBUTED TO THE EVENT. PATIENT LEFT WITH NO LENS PLACED IN THE OCULAR DEXTER (RIGHT EYE). PATIENT REFERRED TO RETINA SPECIALIST. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 19662424 ↗
• InjuryJun 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 FULLY INSERTED IN THE PATIENT'S LEFT EYE AND REMOVED IN THE SAME PROCEDURE DUE TO WEAK ZONULES. THE DOCTOR DID NOT IMPLANT ANYTHING AFTER TO GIVE THE PATIENT TIME TO HEAL. THE ISSUE WAS NOTICED AFTER THE INSERTION OF THE LENS. THERE WAS POSTERIOR CAPSULAR TEAR. VITRECTOMY WAS PERFORMED. THE PATIENT IS DOING FINE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Capsular Bag Tear

  MAUDE report 19454683 ↗
• MalfunctionMay 7, 2024Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS DEFECTIVE. NO FURTHER INFORMATION HAS BEEN SHARED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19263342 ↗
• MalfunctionApr 10, 2024Break; Break

  IT WAS REPORTED THE AR40E MODEL INTRAOCULAR LENS (IOL) WAS FULLY INSERTED INTO THE PATIENT¿S OCULAR SINISTER (LEFT EYE) WHEN THE TRAILING HAPTIC BROKE. THE LENS WAS CUT OUT AND A NEW IOL WITH THE SAME MODEL AND POWER, AR40E 19.5 DIOPTER, WAS INSERTED. PATIENT PROGNOSIS POST-PROCEDURE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19085367 ↗
• MalfunctionSep 11, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) TRAILING HAPTIC WAS BROKE OFF WHEN INSERTING THE LENS INTO THE PATIENTS RIGHT EYE USING EMERALD CARTRIDGE. LENS WAS FULLY INSERTED. THE LENS NEEDED TO BE REMOVED, SURGEON HAD TO ENLARGE THE INCISION AND SUTURES WERE USED TO CLOSE THE INCISION. THE PROCEDURE WAS THEN COMPLETED USING A BACKUP LENS. THE IOL IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED STATED THAT THE BACK UP LENS USED WAS OF SAME MODEL AND DIOPTER. IT WAS CONFIRMED THAT SUTURES WERE USED TO CLOSE THE INCISION AS A STANDARD PROCESS AND THERE WAS NO INJURY. NO OTHER MEDICAL/SURGICAL INTERVENTIONS WERE REQUIRED. THERE WAS NO USE ERROR. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 17722880 ↗
• MalfunctionAug 11, 2023Break; Break

  THE SURGERY CENTER REPORTED BENT HAPTIC WHEN INSERTING THE LENS. IT WAS INDICATED THAT THERE WAS PATIENT CONTACT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17515632 ↗
• MalfunctionAug 11, 2023Break; Break

  IT WAS REPORTED THAT THE HAPTIC OF SENSAR INTRAOCULAR LENS (IOL) WAS BROKEN WHEN INSERTING INTO THE PATIENTS EYE. THERE WAS A PATIENT CONTACT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17515367 ↗
• MalfunctionApr 5, 2023Break; Break

  IT WAS REPORTED THAT A NON PRELOADED INTRAOCULAR LENS IOL HAD OPTICAL DAMAGE. IT IS UNKNOWN IF THERE WAS PATIENT CONTACT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16686737 ↗
• MalfunctionFeb 14, 2023Material Fragmentation; Material Fragmentation

  A CUSTOMER REPORTED TO ANVISA, BRAZIL'S HEALTH AUTHORITY, THAT THE HAPTIC ON AN INTRAOCULAR LENS (IOL) DETACHED WHEN TRYING TO INSERT THE LENS USING THE PROPER TECHNIQUE. NO MORE INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16376565 ↗
• MalfunctionFeb 7, 2023Break; Break

  IT WAS REPORTED THAT THE HAPTICS OF THE INTRAOCULAR LENS (IOL) WERE BROKEN DURING INSERTION INTO PATIENT'S LEFT EYE. THE LENS WAS FULLY INSERTED, HOWEVER, WAS REMOVED AND REPLACED WITH ANOTHER LENS OF SAME MODEL AND DIOPTER DURING THE SAME PROCEDURE. THERE WAS NO PATIENT INJURY AND NO OTHER INTERVENTION WAS REQUIRED. THE ORIGINAL LENS IS NOT AVAILABLE FOR RETURN. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16315730 ↗
• MalfunctionFeb 6, 2023Break; Break

  IT WAS REPORTED THAT DURING IMPLANTATION OF THE INTRAOCULAR LENS (IOL) INTO PATIENT'S OPERATIVE EYE, IT WAS IDENTIFIED THAT THE LENS WAS FAULTY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16308881 ↗
• InjurySep 16, 2022Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  CUSTOMER REPORTED A SENSAR AR40E INTRAOCULAR LENS (IOL) WITH A DEFECT IN ONE OF ITS HAPTICS DURING IMPLANTATION. THERE WAS AN ISSUE OF INSTABILITY AND DECENTRATION. IOL WAS EXPLANTED AND REPLACED BY ANOTHER LENS. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 15441866 ↗
• MalfunctionAug 30, 2022Break; Break

  IT WAS REPORTED THAT A HAPTIC IS OBSERVED TO BE DISTORTED WHEN ATTEMPTING TO DEPLOY. IT WAS NOTED THAT THERE WAS PATIENT CONTACT AND THAT THE LENS WAS DISCOVERED TO HAVE A BENT HAPTIC UPON INJECTING. THERE WAS INCISION ENLARGEMENT MADE BEFORE IMPLANTING THE SUSPECT PRODUCT. OPHTHALMOVISCOSURGICAL DEVICE WAS USED AT TEMPERATURE PER DIRECTIONS FOR USE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15322978 ↗
• MalfunctionJul 25, 2022Break; Break

  IT WAS REPORTED THE INTRAOCULAR LENS (IOL) NOT IMPLANTED DUE TO BROKEN HAPTIC; EXTENT OF PATIENT CONTACT IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15100277 ↗
• MalfunctionJun 23, 2022Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS LOADED INCORRECTLY AND THE HAPTIC WAS BENT. THE LENS HAD CONTACT WITH THE PATIENT'S RIGHT EYE; HOWEVER, THE LENS WAS NOT INSERTED INTO THE EYE. ANOTHER LENS OF THE SAME MODEL AND DIOPTER WAS USED AS THE REPLACEMENT IOL. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE PATIENT WAS FINE POST SURGERY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14795153 ↗
• MalfunctionDec 14, 2021Break; Break

  IT WAS REPORTED THAT TRAILING HAPTIC WAS FOUND BENT DURING IMPLANTATION. THE INTRAOCULAR LENS (IOL) WAS PARTIALLY INSERTED AND REMOVED AND SURGERY WAS COMPLETED WITH A BACK UP LENS OF SAME MODEL AND DIOPTER. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13006794 ↗