SENSAR IOL AR40e (REF AR40E00200)Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 05050474502109), received between Jun 6, 2018 and Sep 18, 2026 — classified as 16 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Break” (30 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 49 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Appropriate Device Problem Term/Code Not Available

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50830898 ↗
• MalfunctionSep 18, 2026Material Fragmentation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50829496 ↗
• MalfunctionJul 27, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50002942 ↗
• MalfunctionJun 19, 2026Device Dislodged or Dislocated

  DURING INTRAOPERATIVE IMPLANTATION THE IMPLANTED INTRAOCULAR LENS (IOL) BECAME DISLODGED FROM THE OPTIC AND WAS REMOVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A REPLACEMENT IOL. NO PATIENT INJURY OCCURRED AND NO UNPLANNED SURGICAL INTERVENTIONS WERE REQUIRED. NO MEDICATIONS OUTSIDE THE STANDARD OF CARE WERE PRESCRIBED, AND NO FURTHER PROCEDURES ARE PLANNED. THE PATIENT OUTCOME IS GOOD AND THE PATIENT REMAINS STABLE WITH NO ADDITIONAL INTERVENTIONS NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25567987 ↗
• MalfunctionApr 30, 2026Break

  IT WAS REPORTED BY THE CUSTOMER THAT THE THREE PIECE MONOFOCAL NON-PRELOADED INTRAOCULAR LENS (IOL) HAD TORN OR BROKEN HAPTIC. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25049649 ↗
• MalfunctionApr 30, 2026Break

  IT WAS REPORTED BY THE CUSTOMER THAT THE THREE PIECE MONOFOCAL NON-PRELOADED INTRAOCULAR LENS (IOL) HAD TORN OR BROKEN HAPTIC. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25049633 ↗
• MalfunctionApr 29, 2026Break

  IT WAS REPORTED THAT A NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), MODEL AR40E, EXPERIENCED TRAILING HAPTIC BREAKAGE DURING INSERTION INTO THE PATIENT¿S LEFT EYE. THE DAMAGED LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS OF THE SAME MODEL AND DIOPTER. ADDITIONAL INFORMATION CONFIRMED THAT NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES WERE REQUIRED. PATIENT INJURY WAS UNKNOWN. THE PATIENT¿S CURRENT OUTCOME FOLLOWING IMPLANTATION OF THE REPLACEMENT LENS WAS ALSO UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25024605 ↗
• MalfunctionApr 7, 2026Break

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS IMPLANTED AND THEN IT WAS NOTICED THE HAPTIC WAS DAMAGE. THE IOL WAS REMOVED. JOHNSON AND JOHNSON PERFORMED FOLLOW-UP TO GET MORE DETAILS. TO DATE NO FURTHER DETAILS HAVE BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24802358 ↗
• MalfunctionMar 30, 2026Ejection Problem

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, A NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) BECAME LODGED IN THE CARTRIDGE DURING INSERTION INTO THE PATIENT¿S LEFT EYE. THE LENS WAS PARTIALLY INSERTED AND SUBSEQUENTLY REMOVED DURING THE SAME PROCEDURE, RESULTING IN AN APPROXIMATE 20-MINUTE DELAY. THE CONDITION OF THE LENS, HAPTICS, AND CARTRIDGE TIP REMAINS UNKNOWN. THE CARTRIDGE MODEL AND LOT NUMBER WERE NOT REPORTED. IT IS UNKNOWN WHETHER INCREASED RESISTANCE WAS ENCOUNTERED OR IF ADDITIONAL FORCE WAS REQUIRED DURING LENS DELIVERY. THE EVENT WAS NOTED TO BE UNRELATED TO USE ERROR. THE PROCEDURE WAS COMPLETED USING A BACKUP IOL OF THE SAME MODEL AND DIOPTER ALONG WITH A BACKUP CARTRIDGE. THE PROCEDURE REQUIRED UNPLANNED INCISION ENLARGEMENT, SUTURING, AND VITRECTOMY. INFORMATION REGARDING THE PRESENCE OF A CAPSULAR TEAR NECESSITATING VITRECTOMY, AS WELL AS THE REASON FOR OR NUMBER OF SUTURES PLACED, IS UNAVAILABLE. THE PATIENT RECOVERED FULLY WITHOUT IMPACT TO DAILY ACTIVITIES. NO MEDICAL ATTENTION OR MEDICATION OUTSIDE OF THE STANDARD OF CARE WAS REQUIRED. IT WAS REPORTED THAT THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT, AND THE DIRECTIONS FOR USE WERE FOLLOWED. NO

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

  MAUDE report 24722400 ↗
• InjuryMar 5, 2026Material Fragmentation

  IT WAS REPORTED THAT THE HAPTIC DETACHED FROM THE LENS OPTIC AFTER IMPLANTATION OF LENS INTO THE PATIENT'S EYE. AN EXPLANT WAS PERFORMED AND THERE WAS LENS REPLACEMENT. THERE WAS NO DELAY IN TREATMENT OR OTHER INTERVENTIONS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24527081 ↗
• InjuryMar 5, 2026Material Fragmentation

  IT WAS REPORTED THAT THE HAPTIC DETACHED FROM THE LENS OPTIC FOLLOWING IMPLANTATION INTO THE PATIENT¿S EYE. AN EXPLANT PROCEDURE WAS PERFORMED, AND THE LENS WAS REPLACED. THERE WAS NO DELAY IN TREATMENT, AND NO ADDITIONAL INTERVENTIONS WERE REPORTED. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24527040 ↗
• MalfunctionDec 26, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT AFTER INSERTING THE NON-PRELOADED INTRAOCULAR LENS (IOL) INTO THE PATIENT'S EYE, THE TRAILING HAPTIC WAS DETACHED. THE IOL WAS REMOVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A REPLACEMENT DEVICE. THERE WERE NO PATIENT INJURY REPORTED, AND NO OTHER MEDICAL INTERVENTION WAS REQUIRED. ACCOUNT INDICATED THAT DURING PROCEDURE THE INCISION WAS ENLARGED AND THE PHYSICIAN SUTURED THE WOUND. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 23899157 ↗
• MalfunctionDec 23, 2025Break; Break

  IT WAS REPORTED THAT THE MONOFOCAL INTRAOCULAR LENS (IOL) WAS EXTRACTED BROKEN. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23880116 ↗
• InjurySep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT LENS EXCHANGE SURGERY IN THE LEFT EYE (OS), REPLACING A NON-JOHNSON & JOHNSON INTRAOCULAR LENS (IOL) WITH A JOHNSON & JOHNSON NON-PRELOADED THREE-PIECE IOL. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED PERSISTENT UNCORRECTABLE BLURRED VISION OS, DESPITE UNDERGOING TWO LENS REPOSITIONING PROCEDURES ON (B)(6) 2024, WHICH DID NOT RESOLVE THE ISSUE. THE PATIENT CLAIMS TO BE UNABLE TO SEE OUT OF OS. PRE-EXISTING CONDITIONS OS, INCLUDING MACULAR PUCKER, CYSTOID MACULAR EDEMA, AND GLAUCOMA, WERE NOTED AS POTENTIAL CONTRIBUTORS TO THE BLURRED VISION. AFTER THE JOHNSON & JOHNSON LENS WAS IMPLANTED, THE PATIENT¿S UNCORRECTED VISUAL ACUITY (VA) SHOWED SIGNIFICANT FLUCTUATIONS, RANGING FROM HAND MOTION ON THE DAY OF THE LENS EXCHANGE TO 20/60 BY (B)(6) 2025, WITH CORRECTED VISION RECORDED AT 20/50 AS OF (B)(6) 2025. THE FOLLOWING UNCORRECTED VISUAL ACUITIES WERE NOTED: ON (B)(6) 2024 VA WAS 20/50, ON (B)(6) 2024 VA WAS 20/200, ON (B)(6) 2024 VA WAS 20/30, ON (B)(6) 2024 VA WAS LIGHT PERCEPTION. UNCORRECTED VA AFTER THE FIRST LENS REPOSITION WERE AS FOLLOWS: (B)(6) 2024 VA WAS 200 AT 7 FEET, ON (B)(6) 2024 VA WAS 200 AT 10 FEET. IN (B)(6) 2024, THE P

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Visual Impairment

  MAUDE report 23000492 ↗
• MalfunctionMay 30, 2025Break; Break

  IT WAS REPORTED THAT THE HAPTIC OF THE NON-PRELOADED INTRAOCULAR LENS (IOL) WAS KINKED PREVENTING ITS INSERTION INTO THE PATIENT'S EYE. THE ISSUE WAS NOTICED DURING HANDLING/PRIOR TO INSERTION OF THE LENS. THE LENS WAS PARTIALLY INSERTED. THE LENS WAS ULTIMATELY REMOVED DURING THE SAME PROCEDURE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22117674 ↗
• MalfunctionMay 1, 2025Break; Break

  IT WAS REPORTED THAT WHEN THE PRELOADED INTRAOCULAR LENS (IOL) WAS INSERTED FULLY INTO THE PATIENT'S RIGHT EYE WAS FOUND TO BE CRACKED WITH A BROKEN HAPTIC. THE LENS WAS REMOVED IN THE SAME PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY PERMANENT OR TEMPORARY IMPAIRMENT AND WAS ABLE TO PERFORM ALL DAILY ACTIVITIES POST-SURGERY. THE DIRECTIONS FOR USE WERE FOLLOWED, AND THERE WAS NO NEED FOR MEDICAL ATTENTION OR MEDICATION OUTSIDE OF STANDARD CARE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21946404 ↗
• MalfunctionFeb 4, 2025Break; Break

  IT WAS REPORTED THAT THE HAPTIC OF A MONOFOCAL INTRAOCULAR LENS (IOL) WAS BENT/BROKE DURING INSERTION INTO THE EYE. THERE WAS PATIENT CONTACT WITH THE DEVICE. THE LENS WAS NOT STUCK IN THE CARTRIDGE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21301332 ↗
• MalfunctionOct 29, 2024Break; Break

  IT WAS REPORTED THAT THE LEAD HAPTIC OF THE NON-PRELOADED MONOFOCAL LENS WAS BENT, WHICH WAS DISCOVERED AFTER INSERTION. IT WAS REMOVED AND REPLACED WITH A NEW LENS DURING THE SAME PROCEDURE. THE PATIENT IS DOING WELL. NO INJURIES OR MEDICAL INTERVENTIONS OCCURRED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20560043 ↗
• InjurySep 5, 2024Break; Break

  IT WAS REPORTED THE NON PRE-LOADED AR40E MODEL INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO BENT HAPTIC. REPLACEMENT IOL INFORMATION IS UNKNOWN. ATTEMPTS WERE MADE TO CONTACT THE CUSTOMER ACCOUNT REQUESTING ADDITIONAL INFORMATION REGARDING COMPLAINT HOWEVER, TO DATE NO RESPONSE HAS BEEN RECEIVED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20153847 ↗
• MalfunctionMay 23, 2024Break; Break

  IT WAS REPORTED THAT THERE WAS A FAULTY NON PRELOADED INTRAOCULAR LENS DUE TO BENT HAPTIC WHICH WAS NOTICED DURING IMPLANTATION. LENS WAS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19388815 ↗
• MalfunctionDec 27, 2023Break; Break

  IT WAS REPORTED THAT THE HAPTICS OF THE NON PRELOADED MONOFOCAL INTRAOCULAR LENS WAS BROKEN ONCE INSERTED INTO THE EYE. ADDITIONAL INFORMATION INDICATED THAT THE LENS WAS FULLY INSERTED AND THE HAPTIC WAS BROKEN BUT NOT DETACHED. THE PROCEDURE COMPLETED SUCCESSFULLY USING BACKUP LENS. THERE WAS NO USE ERROR AND THERE WAS NO PATIENT INJURY. THERE WAS NO MEDICAL/SURGICAL INTERVENTION REQUIRED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18399895 ↗
• MalfunctionDec 21, 2023Break; Break

  IT WAS REPORTED THAT THE LENS WAS EXPLANTED AND ANOTHER ONE IMPLANTED WITH THE SAME DIOPTER. THROUGH FOLLOW-UP WE LEARNED THAT THE LENS WAS EXPLANTED DUE TO A DEFECT IN THE HAPTICS AND THAT IT WAS REMOVED AND REPLACED ON THE SAME DAY. NO FURTHER DETAILS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18379152 ↗
• InjuryOct 30, 2023Break; Break

  IT WAS REPORTED THAT THE NON-PRELOADED INTRAOCULAR LENS (IOL) WAS REMOVED AND REPLACED DURING THE SURGERY DUE TO A DAMAGED HAPTIC. SUTURES WERE REQUIRED FOLLOWING AN INCISION ENLARGEMENT. NO FURTHER DETAIL WAS PROVIDED.

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

  MAUDE report 18035880 ↗
• InjuryOct 13, 2023Break; Difficult to Insert; Adverse Event Without Identified Device or Use Problem; Break; Difficult to Insert; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IOL HAD A POSITIONING ISSUE AND WAS SUBLUXATED POSTERIORLY AS IT WAS IMPLANTED IN THE SULCUS. THERE WAS HAPTIC KINKING. THE LENS WAS FULLY INSERTED INTO THE PATIENT'S EYE. THE PATIENT'S PRE-OPERATIVE VISUAL ACUITY FOR THE LEFT EYE WAS 1/60 AND POST-OPERATIVE VISUAL ACUITY FOR THE LEFT EYE WAS 6/30, AND THE PRE-OPERATIVE VISUAL ACUITY FOR RIGHT EYE WAS 6/45 AND POST-OPERATIVE VISUAL ACUITY FOR RIGHT EYE WAS 6/30. THERE WERE UNPLANNED VITRECTOMY AND SUTURES PERFORMED. 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 17932023 ↗
• MalfunctionSep 18, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS INITIALLY REPORTED THAT THE DOCTOR DID NOT LIKE RESULTS WITH A MONOFOCAL INTRAOCULAR LENS (IOL) AND REFERRED PATIENT TO ANOTHER DOCTOR. PATIENT CONTACT REPORTED. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER INDICATED THAT THE LENS WAS INSERTED AND REMOVED FROM THE EYE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Discomfort

  MAUDE report 17770419 ↗