SENSAR IOL AR40e (REF AR40E00175)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 05050474502055), received between Jun 6, 2017 and Jun 2, 2026 — classified as 4 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2026Break

  IT WAS REPORTED THAT THREE PIECE MONOFOCAL NON-PRELOADED WAS EXPLANTED FOLLOWING POST-OPERATIVE ASSESSMENT DUE TO BROKEN HAPTICS. THE AFFECTED PATIENTS EXPERIENCED TEMPORARY IMPAIRMENT; HOWEVER, THEIR DAILY ACTIVITIES WERE NOT SIGNIFICANTLY IMPACTED. THERE WAS NO NEED FOR INCISION ENLARGEMENT, SUTURES, VITRECTOMY, OR DELAY IN THE PROCEDURE, AND NO ADDITIONAL MEDICAL ATTENTION OR MEDICATION WAS REQUIRED. AS PER ADDITIONAL INFORMATION RECEIVED, LENS WAS FULLY INSERTED INTO PATIENT'S EYE AND LENS WAS REMOVED IN SAME PROCEDURE AND REPLACED WITH LENS OF ANOTHER MODEL. THERE WAS NO ANY PATIENT INJURY. PATIENT IS DOING GOOD. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25361360 ↗
• MalfunctionMay 7, 2026Break

  IT WAS REPORTED THAT THE NON-PRELOADED INTRAOCULAR LENS (IOL) WAS OPENED BUT NOT IMPLANTED, AS IT WAS FOUND TO BE BROKEN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25113710 ↗
• MalfunctionApr 18, 2025Material Fragmentation; Material Fragmentation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21868206 ↗
• MalfunctionFeb 26, 2025Break; Defective Component; Break; Defective Component

  IT WAS REPORTED THAT THE MONOFOCAL INTRAOCULAR LENS (IOL) WAS DEFECTIVE, A HAPTIC TORE OFF. THROUGH FOLLOW UPS, WE LEARNED THAT THE HAPTIC WAS NOT SEPARATED OR BROKEN, BUT WAS ALREADY DEFECTIVE BEFORE IMPLANTATION (TOO SHORT OR INCOMPLETE). THE IOL HAD TO BE DISSECTED AND EXPLANTED DURING THE INITIAL PROCEDURE. A PARS PLANA VITRECTOMY WAS NECESSARY FOR IOL REPOSITIONING. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21472667 ↗
• MalfunctionJan 8, 2024Break; Break

  IT WAS REPORTED THAT THE THAT MONOFOCAL NON PRELOADED INTRAOCULAR LENS HAD EXPLANTED DUE TO BROKEN HAPTIC. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18466409 ↗
• MalfunctionDec 12, 2023Break; Break

  IT WAS REPORTED THAT A SENSAR INTRAOCULAR LENS (IOL) WAS WASTED. IT FAILED PER THE CLINICIAN. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18314957 ↗
• MalfunctionSep 6, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS FULLY INSERTED AND THEN REMOVED AND REPLACED IN THE SAME SURGERY. IT IS UNKNOWN WHAT THE ISSUE WAS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A BACK-UP LENS. THERE WAS NO PATIENT INJURY. NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTIONS OR MANEUVERS OUTSIDE THE STANDARD OF CARE WERE REQUIRED. THE ISSUE WAS NOT DUE TO USE ERROR. THE PATIENT STATUS IS UNKNOWN. THE DEVICE WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17695086 ↗
• InjurySep 14, 2022Material Fragmentation; Inaccurate Delivery; Material Fragmentation; Inaccurate Delivery

  IT WAS REPORTED THAT THE LEADING HAPTIC OF THE INTRAOCULAR LENS (IOL) WAS DETACHED INADVERTENTLY WHEN ABOUT HALF OF THE LENS WAS ALREADY INSIDE THE PATIENT'S RIGHT EYE. THE INCISION WAS ENLARGED. THE LENS AND THE DETACHED HAPTIC WERE REMOVED FROM THE EYE. VITRECTOMY WAS PERFORMED AND SUTURES WERE PLACED. THERE WAS A DELAY OF APPROXIMATELY 45 MINUTES AND MEDICATION WAS PRESCRIBED. THE PATIENT WAS LEFT APHAKIC AS THERE WAS NO SUITABLE LENS (A 3 PIECE IOL) AVAILABLE DURING THE SURGERY TO BE USED AS THE REPLACEMENT IOL. THE PATIENT REMAINED APHAKIC FOR 7 WEEKS ((B)(6) 2022 TO (B)(6) 2022) AND HAD REGULAR FOLLOW-UP CONSULTATIONS DURING THIS TIME. EVENTUALLY, THE PATIENT WAS IMPLANTED WITH A 3 PIECE LENS OF THE SAME POWER AS THE ORIGINAL LENS. THE ORIGINAL LENS WAS DISCARDED. NO OTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 15419380 ↗
• InjuryDec 22, 2020Break; Break

  IT WAS REPORTED THAT A MODEL AR40E INTRAOCULAR LENS (IOL) WAS PARTIALLY INSERTED INTO THE PATIENT'S RIGHT EYE AND THEN REMOVED DUE TO A BROKEN HAPTIC INSIDE THE EYE. A VITRECTOMY, SUTURES, AND INCISION ENLARGEMENT WERE REQUIRED. NO PATIENT INJURY WAS REPORTED. THE REPLACEMENT LENS IS THE SAME LENS MODEL AND DIOPTER. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Code Available; Vitrectomy

  MAUDE report 11061670 ↗
• InjuryApr 27, 2019Failure to Eject; Separation Problem; Failure to Eject; Separation Problem

  IT WAS REPORTED THAT THE HAPTIC WAS BROKEN. THROUGH FOLLOW-UP IT WAS LEARNED THAT THE LENS COULD BE ADVANCED EASILY WITHOUT ISSUE. HOWEVER, WHEN THE IOL WAS IN THE EYE, THE HAPTIC HAD BEEN CAUGHT BY THE PLUNGER AND WAS RIPPED OFF. THE LENS WAS REMOVED FROM THE EYE WHICH REQUIRED THE INCISION TO BE ENLARGED. NO OTHER ISSUES WERE REPORTED AND THE PATIENT OUTCOME IS EXPECTED TO BE GOOD. THE DAMAGED LENS WAS DISCARDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8558890 ↗
• InjuryJun 6, 2017Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT DURING THE IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE RIGHT EYE OF A (B)(6) YEAR-OLD MALE PATIENT, ONE OF THE HAPTICS WAS DETACHED. REPORTEDLY, THE INCISION HAD TO BE ENLARGED TO REMOVE AND REPLACE THE LENS. THE INCISION WAS CLOSED WITH 3 POINTS. THE PATIENT OUTCOME WAS REPORTED BEING GOOD. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6616820 ↗