SENSAR IOL AR40e (REF AR40E00185)Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 05050474502079), received between Aug 18, 2017 and Jun 4, 2026 — classified as 10 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Break” (20 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 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2026Break; Use of Device Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25402284 ↗
• MalfunctionFeb 19, 2026Break

  IT WAS REPORTED THAT THE STANDALONE INTRAOCULAR LENS (IOL) WAS IN CONTACT WITH THE PATIENT BUT THE HAPTIC FELT UNSTABLE, AND IT WAS REMOVED. THROUGH FOLLOW-UP, WE LEARNED THAT THE LENS WAS IMPLANTED, AND SUBSEQUENTLY REMOVED AND REPLACED WITH A LENS OF THE SAME POWER IN THE SAME PROCEDURE. THERE WERE NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24397497 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS IMPLANTED AND EXPLANTED. THE REASON FOR THE EXPLANT WAS NOT SPECIFIED. THE PATIENT OUTCOME POST EXPLANT IS UNKNOWN/NOT PROVIDED. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 24090164 ↗
• MalfunctionJan 2, 2026Break; Scratched Material

  IT WAS REPORTED THAT WHEN THE NON-PRELOADED INTRAOCULAR LENS (IOL) WAS IMPLANTED, A SCRATCH WAS FOUND ON THE OPTIC AND THE HAPTIC WAS BENT. THE INJECTOR AND CARTRIDGE USED WERE FROM A DIFFERENT MANUFACTURER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A REPLACEMENT DEVICE. NO PATIENT INJURY WAS REPORTED. NO OTHER MEDICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23946306 ↗
• InjuryDec 26, 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. FOR UNKNOWN REASONS, THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE; INFORMATION REGARDING THE REPLACEMENT IOL WAS NOT PROVIDED. PATIENT PROGNOSIS POST LENS EXCHANGE IS UNKNOWN. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 23898835 ↗
• MalfunctionNov 19, 2025Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), MODEL AR40E, APPEARED TO BE SCRATCHED PRIOR TO IMPLANTATION. CONTACT WITH THE PATIENT WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23590467 ↗
• MalfunctionOct 15, 2025Break; Break

  IT WAS REPORTED THAT THE HAPTIC OF THE NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS BROKEN WHEN INSERTING INTO THE EYE. THE ISSUE INVOLVED CONTACT WITH THE PATIENT, HOWEVER THE EXTENT OF PATIENT CONTACT IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23286457 ↗
• MalfunctionJun 5, 2025Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED THAT AN MONOFOCAL INTRAOCULAR LENS (IOL) HAD A LOADING ISSUE AND THE HAPTIC BROKE DURING INSERTION. THE LENS WAS IN THE PATIENT'S RIGHT EYE. THROUGH FOLLOW UP, IT WAS LEARNED THAT THE TRAILING HAPTIC BROKE DURING INSERTION. THE IOL WAS REMOVED, CUT, AND REPLACED DURING THE SAME PROCEDURE. ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND DIOPTER) WAS IMPLANTED AS A REPLACEMENT WITH NO ISSUES. THERE WAS NO PATIENT INJURY. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION OUTSIDE OF THE STANDARD CARE. IT WAS REPORTED THAT THE PATIENT NEEDED A RETINAL SURGERY RELATED TO THE SURGICAL COMPLICATIONS AND NOT THE LENS INSERTION. THE IOL IS NOT AVAILABLE FOR RETURN. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22154414 ↗
• MalfunctionApr 25, 2025Break; Break

  IT WAS REPORTED THAT THE NON-PRELOADED LENS INTRAOCULAR LENS (IOL) WAS DEFECTIVE. THERE WAS PATIENT CONTACT WITH THE IOL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21910286 ↗
• MalfunctionMar 20, 2025Break; Break

  IT WAS REPORTED THAT DURING DAY 1 POST-OP, IT WAS NOTICED THAT 1 HAPTIC WAS MISSING. IOL REMAINS IN THE EYE AS IOL WAS IN POSITION AND DID NOT AFFECT THE PATIENT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21653352 ↗
• InjuryNov 19, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT A MONOFOCAL INTRAOCULAR LENS, WAS IMPROPERLY LOADED. A VITRECTOMY WAS PERFORMED AND FOUR SUTURES WERE USED. IT WAS INDICATED THAT THE PROCEDURE WAS COMPLETED IMPLANTING ANOTHER LENS IN THE PATIENT'S LEFT EYE. PATIENT IS FINE. THE SUSPECT PRODUCT WAS DISCARDED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 20727199 ↗
• MalfunctionOct 16, 2024Break; Break

  IT WAS REPORTED THAT THE NON PRELOADED INTRAOCULAR LENS (IOL) BACK END WAS BENT AND THE LENS WAS WASTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20467045 ↗
• MalfunctionOct 1, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A SENSAR MONOFOCAL INTRAOCULAR LENS (IOL) AFTER BEING IMPLANTED, THE DOCTOR NOTICED CONCENTRIC RINGS IN THE IOL, AS IF IT WERE A DIFFRACTIVE MULTIFOCAL INSTEAD OF A MONOFOCAL. THE DOCTOR ENLARGED THE INCISION AND EXPLANTED THE IOL. THE DOCTOR USED ONE SUTURE TO CLOSE THE WOUND. NO PATIENT COMPLICATIONS WERE REPORTED AND HE SUCCESSFULLY IMPLANTED HIS BACKUP IOL. NO OTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 20348920 ↗
• MalfunctionSep 6, 2024Break; Break

  IT WAS REPORTED THAT A MONOFOCAL INTRAOCULAR LENS (IOL) WAS DAMAGED. THE AFFECTED EYE WAS THE LEFT EYE; HOWEVER, THE EXTENT OF PATIENT CONTACT IS UNKNOWN. IT WAS NOTED THAT THE ISSUE WAS NOT RELATED TO USE ERROR. THERE WERE NO MEDICAL AND/OR SURGICAL INTERVENTIONS SUCH AS INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES REQUIRED AND NO SURGICAL/MEDICAL INTERVENTIONS IS PLANNED FOR THE FUTURE. IT WAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20164580 ↗
• InjuryAug 12, 2024Break; Break

  IT IS REPORTED THAT THE NON PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS IMPLANTED AND EXPLANTED DUE TO DAMAGE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19968845 ↗
• MalfunctionJan 8, 2024Break; Break

  IT WAS REPORTED THAT THE NON PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT EYE DUE TO HAPTIC BROKEN. NO INFORMATION ABOUT REPLACED IOL. NO FURTHER INFORMATION IS AVAILABLE. ATTEMPTED TO GATHER ADDITIONAL INFORMATION FROM THE ACCOUNT WITH NO RESPONSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18466425 ↗
• InjuryDec 28, 2023Break; Break

  IT WAS REPORTED THAT THE NON PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS REMOVED AND REPLACED FROM THE PATIENT'S RIGHT EYE DURING THE SAME PROCEDURE BECAUSE THE HAPTIC BROKE RIGHT AFTER IMPLANTATION. THERE WAS AN INCISION ENLARGEMENT, AND SUTURES PERFORMED. THE LENS WAS REMOVED AND REPLACED WITH LENS FROM ANOTHER MANUFACTURER OF THE SAME MODEL AND DIOPTER. THE PATIENT'S POST-PROCEDURE STATUS IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 18410923 ↗
• 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 18321057 ↗
• MalfunctionNov 6, 2023Difficult to Fold, Unfold or Collapse; Failure to Fold; Difficult to Fold, Unfold or Collapse; Failure to Fold

  IT WAS REPORTED THAT THE HAPTIC HAD FOLDING ISSUE AND WAS UNABLE TO UNFOLD. IOL WAS REMOVED AND REPLACED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18076668 ↗
• InjuryMay 10, 2023Material Opacification; Material Opacification

  THE PHYSICIAN REPORTED THAT A PATIENT OF HIS WHO UNDERWENT IMPLANTATION SURGERY IN (B)(6) 2015, PRESENTED WITH OPACIFICATION OF THE AR40E (3PC SENSAR, ACRYLIC SQUARE EDGE LENS) INTRAOCULAR LENS (IOL). THE PATIENT IS DOING WELL AND HAS A GOOD VISUAL ACUITY (VA), 20/20 ¿ 20/30 NOT BEING AN INDICATION FOR AN EXPLANT. PER FOLLOW-UP, AT THE TIME THE COMPLAINT WAS REPORTED, THE PATIENT'S VA WAS FINE, PATIENT WAS ONLY BOTHERED BY THE OPACIFICATION OF THE IOL. SO, THE PHYSICIAN DECIDED TO MONITOR THE CASE. HOWEVER, DURING A POST-OPERATIVE VISIT, THE PATIENT HAS A 20/60, 20/200 VA AND THE DOCTOR INTENDS TO EXPLANT THE LENS IN 1 OR 2 MONTHS, AS THE PATIENT IS COMPLAINING. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 16907628 ↗
• MalfunctionDec 9, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THERE ARE TWO TECHNO VIGILANCE NOTIFICATIONS. IN BOTH CASES, THE SUPPLIER COLLECTS THE MATERIALS AND SENDS THEM TO THE MANUFACTURER FOR ANALYSIS, AFTER THE ANALYSIS WE RECEIVE THE FEEDBACK. IF IT IS FOUND THAT THERE REALLY WAS A MANUFACTURING DEFECT, THE SUPPLIER SENDS A RETURN NOTE REFERRING TO THE SUPPLIES, GENERATING A CREDIT FOR THE HOSPITAL, "LENS WITH ABSENCE OF A HANDLE". SURGEON WAS UNABLE TO IMPLANT THE LENS THAT HAD A MANUFACTURING DEFECT, THE LENS BOX AND LENS WERE KEPT TOGETHER WITH THE CASE FOR LATER ANALYSIS. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT CAPTURES EVENT FOR SUSPECT PRODUCT AR40E, SERIAL NUMBER: (B)(4). THE OTHER SUSPECT PRODUCT MENTIONED WILL BE CAPTURED IN A SEPARATE REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15954962 ↗
• MalfunctionOct 13, 2022Break; Break

  IT WAS REPORTED THAT THE LENS IS DEFECTIVE. IT IS UNKNOWN WHETHER THERE WAS PATIENT CONTACT AND NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15599049 ↗
• InjurySep 30, 2022Break; Break

  IT WAS REPORTED THAT THE TRAILING HAPTIC WAS BROKEN. ISSUE WAS NOTED DURING IMPLANTATION OF A 3 PIECE INTRAOCULAR LENS (IOL) INTO THE PATIENT'S RIGHT EYE. IOL LENS WAS REMOVED FROM THE EYE AND PATIENT WAS LEFT APHAKIC. INCISION WAS ENLARGED, VITRECTOMY WAS REQUIRED, SUTURES WERE REQUIRED, AND MEDICATION WAS PRESCRIBED. THERE WAS A 40 MINUTE DELAY IN PROCEDURE. PATIENT STATUS HAD BEEN INDICATED AS TEMPORARILY IMPAIRED. VISION PRE-OPERATIVE: 6/60 AND VISION POST-OPERATIVE: 6/18 +10. NO FURTHER INFORMATION PROVIDED.

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

  MAUDE report 15510204 ↗
• InjurySep 14, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL), MODEL AR40E, WAS REMOVED FROM THE PATIENT'S LEFT EYE DURING IMPLANTATION. CUSTOMER PROVIDED THAT WHEN INSERTING THE LENS, IT WAS NOTICED THAT THE HAPTIC BROKE OFF AND THE IOL FELL BEHIND THE PATIENT¿S EYE. THERE WAS NO PATIENT INJURY REPORTED. PATIENT WAS REPORTEDLY DOING FINE POST OPERATIVELY AND WAS REFERRED TO A RETINA SPECIALIST. PATIENT HAS NOT BEEN BACK TO HAVE ANOTHER LENS IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 12472033 ↗
• InjuryMay 26, 2021Break; Break

  IT WAS REPORTED THAT A FULLY INSERTED INTRAOCULAR LENS (IOL) WAS REMOVED AND REPLACED FROM THE RIGHT EYE OF A PATIENT DURING THE SAME PROCEDURE DUE TO THE BENT/BROKEN HAPTIC. IT WAS NOTED THAT A VITRECTOMY WAS PERFORMED. THE LENS WAS CUT AND REMOVED AND A DIFFERENT MODEL, NON-JOHNSON & JOHNSON LENS WAS USED AS A REPLACEMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11882868 ↗