SENSAR IOL AR40e (REF AR40E00225)Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 05050474502154), received between Mar 15, 2017 and May 8, 2026 — classified as 14 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Break” (16 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 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2026Break

  IT WAS REPORTED THAT A NON-PRELOADED MONOFOCAL INTRAOCULAR LENS HAPTIC BROKE DURING INSERTION AND WAS NOTICED AFTER THE LENS HAD BEEN IMPLANTED; CONSEQUENTLY, THE LENS WAS REMOVED DURING THE SAME PROCEDURE. DIRECTIONS FOR USE HAD BEEN FOLLOWED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25126674 ↗
• MalfunctionFeb 6, 2026Break

  IT WAS REPORTED THAT THE STANDALONE INTRAOCULAR LENS (IOL) IS DEFECTIVE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24284934 ↗
• MalfunctionFeb 2, 2026Break

  IT WAS REPORTED THAT A LENS HAPTIC FRACTURED AFTER IMPLANTATION. THE SURGEON REMOVED THE LENS AND IMPLANTED A REPLACEMENT. THE PATIENT RECOVERED WELL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24242648 ↗
• MalfunctionOct 30, 2025Break; Break

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) HAD A BROKEN HAPTIC. IT WAS EXPLAINED THAT THE TRAILING HAPTIC BROKE DURING IMPLANTATION. THE IOL WAS FULLY INSERTED. IT WAS CUT AND REMOVED. A VITRECTOMY WAS PERFORMED. THE PROCEDURE WAS COMPLETED WITH A BACKUP IOL. THE DIRECTIONS FOR USE WERE FOLLOWED. THERE WAS NO SECONDARY SURGERY OR UNPLANNED SUTURES. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23432701 ↗
• MalfunctionSep 5, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE SUPERIOR LOOP OF A NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) BECAME DETACHED DURING THE INSERTION PROCESS. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22984207 ↗
• InjuryAug 13, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING A PROCEDURE THE INTRAOCULAR LENS WAS IMPLANTED BUT THE LENS DID NOT SEAT AS INTENDED, AND UPON REMOVAL, IT CAUSED THE PATIENT'S ENTIRE IRIS TO BE EXTRACTED. NO REPLACEMENT LENS WAS IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 22790815 ↗
• MalfunctionJun 13, 2025Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22207958 ↗
• InjuryMay 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CASE INVOLVING THE AR40E MODEL INTRAOCULAR LENS (IOL) TURNED INTO A COMPLICATED ANTERIOR VITRECTOMY DUE TO THE PATIENT'S ANATOMY. THE DOCTOR HAD TO USE FOUR (04) LENSES AND THREE (03) WERE DESTROYED IN THE SURGICAL PROCESS. THE SURGERY WAS COMPLETED DURING THE SAME PROCEDURE. PATIENT PROGNOSIS POST PROCEDURE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 22111030 ↗
• InjuryMay 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CASE INVOLVING THE AR40E MODEL INTRAOCULAR LENS (IOL) TURNED INTO A COMPLICATED ANTERIOR VITRECTOMY DUE TO THE PATIENT'S ANATOMY. THE DOCTOR HAD TO USE FOUR (04) LENSES AND THREE (03) WERE DESTROYED IN THE SURGICAL PROCESS. THE SURGERY WAS COMPLETED DURING THE SAME PROCEDURE. PATIENT PROGNOSIS POST PROCEDURE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 22110960 ↗
• MalfunctionMar 18, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE HAPTIC OF THE NON-PRELOADED INTRAOCULAR LENS (IOL) WAS DETACHED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21635632 ↗
• MalfunctionNov 12, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT THE THREE PIECE MONOFOCAL NON PRELOADED INTRAOCULAR LENS (IOL) WAS RECEIVED WITH BROKEN SEAL. THERE WAS NO CONTACT WITH PATIENT'S EYE. AS PER ADDITIONAL INFORMATION RECEIVED, IT IS UNKNOWN WHETHER THERE WAS ANY BREACH OR POTENTIAL BREACH IN STERILITY OF THE IOL. ONLY ONE BOX WAS INVOLVED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20668273 ↗
• MalfunctionApr 10, 2024Scratched Material; Scratched Material

  IT WAS REPORTED THAT A MONOFOCAL INTRAOCULAR LENS WAS FULLY INSERTED AND REMOVED IN THE SAME PROCEDURE DUE TO A DENT IN THE LENS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING DIFFERENT MODEL MONOFOCAL IOL. THERE WAS NO INJURY, AND SURGICAL AND MEDICAL INTERVENTIONS WERE REQUIRED. THE PATIENT IS DOING WELL. THE PRODUCT IS BEING RETUNED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19077109 ↗
• MalfunctionDec 27, 2023Break; Break

  IT WAS REPORTED THAT THE HAPTIC OF THE NON PRELOADED MONOFOCAL INTRAOCULAR LENS(IOL) WAS KINKED, WHEN IT WAS IMPLANTED. ADDITIONAL INFORMATION INDICATED THAT THE LENS WAS FULLY INSERTED AND THE HAPTIC WAS BROKEN BUT NOT DETACHED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING BACKUP LENS. THERE WAS NO USE ERROR AND THERE WAS NO PATIENT INJURY. THERE WAS NO MEDICAL/SURGICAL INTERVENTION REPORTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18399847 ↗
• MalfunctionDec 13, 2023Break; Break

  IT WAS REPORTED THERE WAS HAPTIC BENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18321455 ↗
• MalfunctionOct 3, 2023Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS UNDERGOING A PLANNED SCLERAL FIXATED SECONDARY INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE IN THEIR LEFT EYE. WHEN THE IOL WAS INTRODUCED INTO THE ANTERIOR CHAMBER OF THE PATIENT'S EYE, THE TRAILING HAPTIC BROKE. THE IOL WAS REMOVED AND REPLACED WITH A NON-JOHNSON&JOHNSON LENS. THERE WERE MEDICATIONS PRESCRIBED AS PART OF STANDARD OF CARE, AND PLANNED SUTURES WERE PLACED. ACCOUNT INDICATED THAT THE PATIENT WAS WELL POST-OPERATIVELY AND VISION WAS OKAY. 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 17864749 ↗
• MalfunctionAug 17, 2023Break; Break

  THE CUSTOMER REPORTED OPEN, WASTED, LENS DAMAGE WITH AN INTRAOCULAR LENS (IOL) FOR THE LEFT EYE OF A PATIENT. IT IS UNKNOWN IF THERE WAS PATIENT CONTACT. IT WAS INDICATED THAT THE ISSUE IS NOT RELATED TO USE ERROR. THERE WERE NO MEDICAL AND OR SURGICAL INTERVENTIONS REQUIRED. THE IOL IS NOT RETURNING AS IT WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17569528 ↗
• InjuryAug 31, 2022Material Fragmentation; Device Dislodged or Dislocated; Material Fragmentation; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) LEADING HAPTIC WAS BROKEN AND WAS NOT VISIBLE ON INSERTION IN THE PATIENT¿S RIGHT EYE, IOL WAS DEFECTIVE. UPON FURTHER FOLLOW-UP, WE LEARNED THAT THE IOL WAS FULLY INSERTED. ACCOUNT INDICATED THAT THE LENS DROPPED TO THE BACK OF THE EYE RESULTING IN VITRECTOMY. THE LENS WAS REMOVED AND REPLACED IN THE SAME PROCEDURE DURING WHICH A COMPETITOR LENS WAS IMPLANTED. SUTURES WERE PLACED. NO TREATMENT OR PRESCRIPTION WAS GIVEN BY THE DOCTOR OUTSIDE THE REGULAR STANDARD OF CARE. THE PATIENT IS FINE PRESENTLY AND IS BEING MONITORED. THE LENS IS AVAILABLE FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 15325723 ↗
• MalfunctionJul 18, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING THE IMPLANTATION OF THE INTRAOCULAR LENS (IOL), THE HAPTIC BROKE OFF. THE IOL WAS REMOVED DURING THE SAME PROCEDURE AND ANOTHER LENS OF THE SAME MODEL AND DIOPTER WAS IMPLANTED. THE PATIENT IS DOING WELL WITH NO FURTHER COMPLICATIONS. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15047994 ↗
• MalfunctionMay 4, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT UPON FURTHER CLARIFICATION, AN INTRAOCULAR LENS (IOL) WAS REMOVED AND REPLACED DUE TO THE AMPUTATION OF THE HAPTIC. IT WAS NOT DURING ASSEMBLY, IT WAS MOUNTED, AND AT THE TIME OF INSERTING THE LENS THE AMPUTATION WAS VERIFIED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14274509 ↗
• InjuryApr 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD INTRAOCULAR LENS (IOL) IMPLANT IN THE RIGHT EYE. TWO WEEKS LATER, THE PATIENT RETURNED DUE TO REDNESS AND LACRIMATION (TEARING) IN THE RIGHT EYE. EXAMINATION SHOWED MILD CONJUNCTIVAL CONGESTION IN THE RIGHT EYE, WEAKLY POSITIVE CILIARY TENDERNESS, FLOCCULENT EXUDATES IN FRONT OF THE ANTERIOR CHAMBER INTRAOCULAR LENS, AND SLUGGISH LIGHT REFLEX. MEDICATION WAS PRESCRIBED. ATROPINE EYE GEL EYE DROPS THREE TIMES A DAY; SUBCONJUNCTIVAL INJECTION OF DEXAMETHASONE INJECTION 2.5 MG ONCE; TOBRAMYCIN DEXAMETHASONE EYE DROPS THREE TIMES A DAY; TOBRAMYCIN DEXAMETHASONE EYE OINTMENT ONCE EVERY NIGHT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Conjunctivitis; Excessive Tear Production; Red Eye(s)

  MAUDE report 14018360 ↗
• InjuryJan 5, 2022Break; Break

  IT WAS REPORTED THAT THE HAPTIC OF THE INTRAOCULAR LENS (IOL) WAS BROKEN DURING IMPLANTATION OF THE LENS INTO PATIENT'S OPERATIVE EYE. THE INCISION WAS ENLARGED AND THE LENS WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE. ADDITIONALLY, SUTURES WERE REQUIRED AND VITRECTOMY WAS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13163046 ↗
• InjurySep 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL), MODEL AR40E, WAS REMOVED AND REPLACED FROM THE PATIENT'S LEFT EYE DURING THE SAME PROCEDURE DUE TO CAPSULE TEAR. A COMPETITOR LENS WAS IMPLANTED AS THE REPLACEMENT. ACCOUNT PROVIDED THAT THE OUTCOME DID NOT SIGNIFICANTLY INTERFERE WITH THE PATIENT'S DAILY LIFE ACTIVITIES. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Capsular Bag Tear

  MAUDE report 12478551 ↗
• MalfunctionAug 13, 2021Break; Break

  IT WAS REPORTED THAT DOCTOR DIDN'T LIKE THE LOOK OF A AR40E MODEL INTRAOCULAR LENS(IOL). NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12321244 ↗
• InjuryJul 6, 2021Break; Inaccurate Delivery; Break; Inaccurate Delivery

  CUSTOMER PARTIALLY INSERTED AN INTRAOCULAR LENS (IOL) ON PATIENT'S RIGHT EYE (OD) WHEN THE PHYSICIAN NOTICED ONE OF ITS HAPTICS WAS BROKEN AND COULD NOT BE FULLY IMPLANTED. LENS WAS REMOVED ON THE SAME PROCEDURE. MEDICATION WAS PRESCRIBED. PATIENT WAS TEMPORARILY INJURED AND DAILY ACTIVITIES WAS AFFECTED. THE PATIENT HAD ALREADY USED THE PRODUCT BEFORE. THE PATIENT NEEDED TO RETURN THE DAY AFTER TO PUT IN ANOTHER LENS. THE CUSTOMER UNDERSTAND PATIENT HAD HIS ACTIVITIES AFFECTED. NOTHING WITH A HIGH LEVEL OF CONCERN, OR THAT COULD BRING ANY DISTRESS. THE MEDICATION PRESCRIBED WAS PART OF THE POST OPERATIVE ROUTINE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12124787 ↗
• InjuryMay 7, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT LENS WAS NOT IMPLANTED FOR INTRAOPERATIVE COMPLICATION. AFTER FOLLOW-UP WE LEARNED THAT DURING THE SURGERY THERE WAS A POSTERIOR CAPSULAR RUPTURE. IT WAS STATED THAT THE LENS DID NOT GUARANTEE STABILITY AS IT MOVED IN THE VITREOUS SO FOR THAT REASON IT WAS REMOVED. NO PATIENT IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Capsular Bag Tear

  MAUDE report 11791791 ↗