SENSAR IOL AR40e (REF AR40E00160)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 05050474502024), received between Aug 22, 2017 and Jan 8, 2026 — classified as 3 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 8, 2026Break

  IT WAS REPORTED THAT THE NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS OPENED AND REMOVED FROM A PATIENT DUE TO A BROKEN HAPTIC. NO PATIENT HARM WAS REPORTED. THE DEVICE WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24016624 ↗
• MalfunctionNov 13, 2025Break; Break

  IT WAS REPORTED THAT HAPTIC WAS DAMAGED AND THERE WAS PATIENT CONTACT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23547820 ↗
• MalfunctionJul 5, 2024Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAD DEFECTIVE HAPTICS. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19684998 ↗
• MalfunctionJun 24, 2024Break; 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 19601301 ↗
• MalfunctionMay 16, 2023Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS FULLY INSERTED AND THEN REMOVED IN PIECES AFTER DOCTOR NOTICED THE SMALL TEAR NOTED ON THE SURFACE OF POSTERIOR IOL. IT WAS REPLACED WITH THE BACK-UP IOL, SAME MODEL AND DIOPTER SIZE. NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES DONE. PATIENT WAS WELL POST-OP, NO POST-OP INJURY. SUSPECT IOL DISCARDED AS IT IS ALREADY IN PIECES. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16940262 ↗
• MalfunctionApr 5, 2022Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS DEFECTIVE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14016000 ↗
• InjuryAug 16, 2019Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT SURGEON HAD TO REMOVE A LENS THAT WAS INSERTED UPSIDE DOWN. ADDITIONAL INFORMATION WAS RECEIVED, AND IT WAS LEARNT THAT THE LENS WAS INSERTED, REMOVED AND REPLACED IN SAME SURGICAL PROCEDURE. THE HAPTIC BROKE WHILE TRYING TO ROTATE THE LENS. THERE WAS PLANNED VITRECTOMY PERFORMED. REPORTEDLY THERE WAS NO PATIENT INJURY. PATIENT WAS DOING WELL. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Vitrectomy

  MAUDE report 8900815 ↗
• MalfunctionMar 12, 2019Break; Break

  IT WAS REPORTED THAT AN AR40E 16.0 DIOPTER MONOFOCAL LENS HAPTIC SNAPPED WHILE THE DOCTOR USED A HOOK TO UNFOLD THE LENS AND SET IT IN THE RIGHT SPOT. THERE WAS NO INCISION ENLARGEMENT. SUTURES WERE USED BUT WERE ALREADY PLANNED. REPORTEDLY, THE PATIENT IS IN GOOD CONDITION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8410802 ↗
• InjuryFeb 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED ENDOPHTHALMITIS AND POSTERIOR CAPSULAR OPACIFICATION (PCO) POST-OPERATIVELY AFTER THE IMPLANTATION OF AN AR40E 16.0 DIOPTER INTRAOCULAR LENS (IOL). REPORTEDLY, IT WAS DIFFICULT TO SEE ANY ISSUES FOR THE FIRST WEEK POST-OPERATIVELY AND THE SYMPTOMS WORSENED TO UNAIDED VISUAL ACUITY 0.2. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Endophthalmitis; No Code Available; Visual Impairment

  MAUDE report 8333396 ↗
• InjuryAug 22, 2017Break; Break

  IT WAS REPORTED THAT DURING THE IMPLANTATION OF AN INTRAOCULAR LENS (IOL), ONE HAPTIC BROKE INSIDE THE PATIENT'S EYE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient; Vitrectomy

  MAUDE report 6809407 ↗