SENSAR IOL AR40e (REF AR40E00140)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 05050474501980), received between Dec 13, 2019 and Jan 30, 2026 — classified as 3 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (3 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.

• InjuryJan 30, 2026Mechanical Jam

  IT WAS REPORTED THAT DURING INSERTION INTO THE PATIENT'S LEFT EYE, A NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), MODEL AR40E, FAILED TO DEPLOY AND BECAME STUCK IN THE CARTRIDGE. THE PROCEDURE REQUIRED INCISION ENLARGEMENT, PLACEMENT OF SUTURES, AND ADDITIONAL MEDICAL INTERVENTION. A REPLACEMENT LENS OF THE SAME MODEL AND DIOPTER WAS IMPLANTED. THE PATIENT¿S OUTCOME WAS GOOD, AND NO INJURY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 24227694 ↗
• MalfunctionJul 11, 2025Break; Break

  IT WAS REPORTED THAT THE STANDALONE 3-PIECE MONOFOCAL INTRAOCULAR LENS (IOL) WAS FAULTY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22480922 ↗
• MalfunctionDec 31, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE NON-PRELOADED INTRAOCULAR LENS (IOL) HAPTIC WAS DETACHED INSIDE THE INJECTOR DURING IMPLANTATION. THE INJECTOR WAS DEFECTIVE AND THE LENS WAS IN CONTACT WITH THE PATIENT'S EYE. THROUGH FOLLOW-UP, WE LEARNED, THAT THE PATIENT IS WELL. THE LENS WAS REMOVED AND REPLACED WITH A NEW LENS WITH THE SAME DIOPTER. NO FURTHER INFORMATION WAS PROVIDED. NOTE: A SEPARATE REPORT WILL BE SUBMITTED UNDER THE NUMBER 3012236936-2024-0003487, TO CAPTURE THE INJECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21048624 ↗
• MalfunctionSep 25, 2024Break; Break

  IT WAS REPORTED THAT THE HAPTIC OF A NON PRELOADED INTRAOCULAR LENS WAS BROKEN DURING MANUAL LOADING. LENS CAN NOT BE FIXED TO THE EYE. THROUGH FOLLOW UP IT WAS LEARNT THAT THE LENS HAD PATIENT CONTACT. IT WAS PARTIALLY INSERTED AND REMOVED AS IT COULD NOT BE FIXED TO EYE. THE PROCEDURE WAS COMPLETED USING SAME MODEL 13.5 DIOPTER BACKUP LENS. POS-PROCEDURE PATIENTS OUTCOME WAS UNEVENTFUL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20303778 ↗
• MalfunctionJul 18, 2024Scratched Material; Scratched Material

  IT WAS REPORTED THAT AFTER IMPLANTING THE INTRAOCULAR LENS (IOL), A SCRATCH WAS NOTICED ON THE OPTICS OF THE LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19779481 ↗
• MalfunctionJul 11, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED WHEN INSERTING THE NON-PRELOADED AR40E MODEL INTRAOCULAR LENS (IOL) INTO THE PATIENT'S EYE THE INCISION WAS NOT LARGE ENOUGH AND THE HAPTIC TORE OFF. THE IOL WAS PARTIALLY INSERTED WHEN THE EVENT OCCURRED. THE IOL WAS NOT STUCK IN THE CARTRIDGE AND THERE WAS NO PATIENT INJURY HOWEVER IT IS UNKNOWN IF MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. ANOTHER IOL WITH THE SAME MODEL AND DIOPTER, AR40E 14.0 DIOPTER, WAS IMPLANTED INTO THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). PATIENT STATUS POST-PROCEDURE WAS REPORTED AS FINE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19725944 ↗
• MalfunctionDec 28, 2023Break; Break

  IT WAS REPORTED THAT THE NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) HAD HAPTIC BROKE OFF AFTER IMPLANTATION IN THE EYE. THERE WAS NO MEDICAL AND SURGICAL INTERVENTION NEEDED. IT IS UNKNOWN WHETHER THE LENS WAS REMOVED AND REPLACED. THE PATIENT'S POST-PROCEDURE STATUS IS DOING WELL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18411246 ↗
• MalfunctionMay 11, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16911574 ↗
• InjuryJul 9, 2021Material Fragmentation; Material Fragmentation

  THE DOCTOR REPORTED THEIR CARTRIDGE PRESENTED A DEFECT; AND WHEN THEY TRIED TO IMPLANT THE LENS, THE HANDLE TORE. LENS INSERTED IN THE LEFT EYE AND REMOVED IN THE SAME PROCEDURE, WHICH CAUSED A DELAY IN THE TREATMENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12144793 ↗
• InjuryDec 13, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ON (B)(6) 2019 ONE HAPTIC WAS OUT OF THE ANTERIOR CHAMBER. IT WAS INDICATED THAT THE CONTINUOUS CURVILINEAR CAPSULORRHEXIS (CCC) SIZE WAS AROUND 6 MM, VITREOUS PRESSURE WAS NORMAL. THE POSITION OF HAPTIC WAS RESTORED BY SURGERY AND MIOTICS WERE INSTALLED TO PREVENT HAPTIC FROM COMING OUT. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9463662 ↗