SENSAR IOL AR40e (REF AR40E00165)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 05050474502031), received between Aug 19, 2021 and Feb 9, 2026 — classified as 1 injury, 9 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.

• MalfunctionFeb 9, 2026Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS DEFECTIVE. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24300454 ↗
• MalfunctionNov 14, 2025Break; Break

  IT WAS REPORTED THAT ONE OF THE INTRAOCULAR LENS (IOL) HAPTICS BROKE WHEN ADJUSTING THE HAPTIC DURING IMPLANTATION OF INTRAOCULAR LENS INTO THE PATIENT'S EYE. THERE WAS INCISION ENLARGEMENT TO REMOVE THE IOL. THERE WAS ALSO SUTURES PERFORMED, MEDICATIONS PRESCRIBED. THERE WAS DELAY IN TREATMENT. PATIENT WAS PERMANENTLY IMPAIRED. PATIENT HAD PERCEPTION OF LIGHT VISION PRE AND POST OPERATION. THERE WERE NO OTHER INTERVENTIONS. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 23560154 ↗
• MalfunctionMar 10, 2025Break; Break

  THE HAPTIC OF THE AR40E MODEL INTRAOCULAR LENS (IOL) WAS BROKEN/TORN AND IT IS UNKNOWN IF THE IOL HAD CONTACT WITH THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21567020 ↗
• MalfunctionDec 4, 2024Break; Material Fragmentation; Break; Material Fragmentation

  THE HAPTIC OF THE NON PRE-LOADED AR40E MODEL INTRAOCULAR LENS (IOL) APPEARED TO BE DAMAGED. THERE WAS PATIENT CONTACT SINCE THE CARTRIDGE WAS REMOVED FROM THE PATIENT'S EYE BEFORE IMPLANTATION OF THE IOL. HAPTIC DAMAGE WAS CLARIFIED AS BENT AND DETACHED. THE LENS WAS NOT STUCK IN THE CARTRIDGE AND THE REPORTED ISSUE WAS POSSIBLY RELATED TO USE ERROR ALTHOUGH IT'S NOT DEFINITIVE. A SECOND AR40E 16.5 DIOPTER LENS WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). DURING THE PROCEDURE THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR SURGICAL INTERVENTION. PATIENT PROGNOSIS POST-PROCEDURE IS UNKNOWN. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20840003 ↗
• MalfunctionJan 8, 2024Break; Break

  IT WAS REPORTED BY THE CUSTOMER THAT THE NON-PRELOADED INTRAOCULAR LENS (IOL) HAD BROKEN HAPTIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18466262 ↗
• InjuryOct 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS CUT OUT DUE TO WEEK ZONULES AFTER MINUTES OF IMPLANT. ANOTHER NON J&J LENS WAS IMPLANTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Zonular Dehiscence

  MAUDE report 17902187 ↗
• MalfunctionMar 27, 2023Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAPTIC BROKE AFTER IMPLANTATION IN THE PATIENT'S OPERATIVE EYE. IT IS UNKNOWN IF THE IOL REMAINS IN THE PATIENT EYE OR IF IT WAS REMOVED AND REPLACED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16622561 ↗
• MalfunctionApr 5, 2022Break; Break

  CUSTOMER CORRESPONDENCE WAS RECEIVED INDICATING THAT THERE WAS A HAPTIC DEFECT. DESPITE SEVERAL FOLLOW UPS, NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14018437 ↗
• MalfunctionDec 14, 2021Break; Inaccurate Delivery; Break; Inaccurate Delivery

  IT WAS REPORTED THAT A AR40E MODEL INTRAOCULAR LENS(IOL) WAS PARTIALLY INSERTED AND TRAILING HAPTIC WAS BENT. THERE WAS NO PATIENT INJURY AND NO MEDICAL/ SURGICAL INTERVENTIONS SUCH AS INCISION ENLARGEMENT, VITRECTOMY OR SUTURES WERE DONE. PROCEDURE WAS COMPLETED SUCCESSFULLY USING BACKUP LENS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13006813 ↗
• MalfunctionAug 19, 2021Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) BROKE INSIDE THE CARTRIDGE. AN ADVERSE EVENT OF PAIN WAS ALSO REPORTED. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Eye Pain

  MAUDE report 12343742 ↗