SENSAR IOL AR40E (REF AR40E00035)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 05050474514072), received between Dec 21, 2018 and Dec 2, 2025 — classified as 6 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE AR40E MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OPERATIVE EYE. THE IOL WAS EXPLANTED FOR UNKNOWN REASONS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 23698198 ↗
• InjuryJul 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT NON-PRELOADED THREE-PIECE MONOFOCAL INTRAOCULAR LENS WAS EXPLANTED DURING A SECONDARY SURGERY BECAUSE THE PATIENT WAS UNABLE TO ADAPT AND EXPERIENCED SYMPTOMS OF BLACK HALOS AND DYSPHOTOPSIA. THE LENS WAS SUBSEQUENTLY REPLACED WITH THE SAME MODEL. THERE WERE NO REPORTS OF UNPLANNED VITRECTOMY, INCISION ENLARGEMENT, OR THE NEED FOR ADDITIONAL SUTURES. DIRECTIONS OF USE WERE FOLLOWED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 22386914 ↗
• MalfunctionJan 7, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING THE INSERTION OF A NON-PRELOADED MONOFOCAL LENS, THE LENS WAS ONLY PARTIALLY INSERTED. IT WAS REPLACED WITH ANOTHER JOHNSON & JOHNSON LENS. THE DAMAGED LENS WAS SUBSEQUENTLY DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21092624 ↗
• MalfunctionDec 30, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS BROKE DURING INSERTION INTO THE PATIENT'S RIGHT EYE. FROM ADDITIONAL INFORMATION IT WAS LEARNT THAT THE HAPTIC BROKE OFF BEFORE COMING OUT OF THE CARTRIDGE. THERE WAS NO USE ERROR. THE LENS WAS PARTIALLY INSERTED REMOVED AND REPLACED WITH A BACK UP LENS OF THE SAME MODEL AND SAME DIOPTER IN THE SAME PROCEDURE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21044478 ↗
• MalfunctionOct 16, 2024Break; Break

  IT WAS REPORTED THAT A NON PRELOADED INTRAOCULAR LENS (IOL) PRODUCT HAS BENT HAPTIC NOTED WHILE INSERTING INTO EYE. THERE WAS PATIENT CONTACT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20467289 ↗
• MalfunctionAug 14, 2024Break; Break

  IT WAS REPORTED THAT THE HAPTIC OF A THREE PIECE MONOFOCAL NON-PRELOADED INTRAOCULAR LENS (IOL) WAS BENT AFTER INJECTION. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19987210 ↗
• MalfunctionJun 28, 2024Break; Break

  IT IS REPORTED THAT THE NON PRELOADED MONOFOCAL INTRAOCULAR LENS(IOL) WAS EXPLANTED DUE TO HAPTIC MESSING UP. NO INFORMATION WAS PROVIDED ABOUT REPLACEMENT LENS. THE DEFECTIVE LENS IS AVAILABLE FOR RETURN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19638701 ↗
• InjurySep 1, 2022Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT REQUIRED AN EXPLANT OF THE INTRAOCULAR LENS (IOL) FROM THEIR LEFT EYE (OS) IN A SECONDARY SURGERY. THE REASON FOR THE EXPLANT WAS NOT SPECIFIED AND THE PATIENT OUTCOME WAS NOT PROVIDED. NO FURTHER INFORMATION AVAILABLE.

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

  MAUDE report 15332779 ↗
• InjuryJun 2, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS FULLY IMPLANTED IN THE PATIENT'S RIGHT EYE AND REMOVED DURING THE SAME SURGERY. IT WAS BELIEVED THAT THE TECHNICIAN LOADED THE IOL BACKWARDS OR UPSIDE DOWN. THE SURGEON NOTICED THE IOL WAS INCORRECT AFTER FULLY INSERTING THE IOL AND DECIDED TO REMOVE IT, REPLACING IT WITH A BACK UP IOL. AN UNPLANNED VITRECTOMY WAS PERFORMED. THERE WAS NO OTHER SURGICAL INTERVENTION REQUIRED AND THERE WAS NO PATIENT INJURY. THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14583843 ↗
• MalfunctionOct 19, 2021Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAPTIC WAS BROKEN. REPORTEDLY, NO ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED. THE PATIENT HAS RECOVERED FROM THE SURGERY. THE CUSTOMER INDICATED THE LENS WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12662121 ↗
• InjuryApr 23, 2021Material Opacification; Material Opacification

  IT WAS REPORTED THAT WHITE SUBSTANCES LIKE CALCIUM DEPOSITS WERE OBSERVED BY THE SURGEON ON ONE SIDE OF THE INTRAOCULAR LENS (IOL) AFTER IT WAS IMPLANTED. THE LENS WAS REMOVED DURING THE SAME SURGERY AND A REPLACEMENT LENS OF THE SAME MODEL AND DIOPTER WAS SUCCESSFULLY IMPLANTED. REPORTEDLY, THE SURGEON DID NOT INSPECT THE LENS PRIOR TO LOADING INTO THE CARTRIDGE. IT WAS INDICATED THAT THE INCISION WAS ENLARGED AND SUTURES WERE USED. THE PATIENT OUTCOME AT THE TIME OF DISCHARGE WAS GOOD AND NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 11714396 ↗
• InjuryAug 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LENS WAS EXPLANTED FROM PATIENT¿S RIGHT EYE IN SECONDARY SURGICAL PROCEDURE BECAUSE OF PATIENT EXPERIENCING UNEXPECTED POST OP REFRACTION. THERE WAS NO INCISION ENLARGEMENT. PATIENT HAS RECOVERED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10365280 ↗
• MalfunctionDec 31, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT WHEN INSERTING A MODEL AR40E 3.5 DIOPTER INTRAOCULAR LENS (IOL) INTO THE EYE, THE HAPTIC BROKE OFF. THERE WAS PATIENT CONTACT; HOWEVER, THERE WAS NO PATIENT INJURY. THERE WAS NO INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY, NO SUTURE(S), NO VITRECTOMY, AND THE SAME MODEL LENS WAS USED AND SUCCESSFULLY IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8207308 ↗
• MalfunctionDec 21, 2018Break; Break

  IT WAS REPORTED THAT AN AR40E 3.5 DIOPTER LENS WAS IMPROPERLY LOADED AND THE HAPTIC BECAME DISTORTED WHILE INSERTING INTO THE PATIENT'S OPERATIVE EYE. THEREFORE, THE LENS WAS REMOVED AND REPLACED. THERE WAS NO INCISION ENLARGEMENT. REPORTEDLY, THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8192340 ↗