SENSAR IOL AR40e (REF AR40E00270)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05050474502239), received between Mar 3, 2017 and Jun 4, 2025 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT A NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) HAPTIC WAS BROKEN, WHICH WAS IDENTIFIED AFTER FULL IMPLANTATION DURING A PROCEDURE. THE LENS WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE WITH ANOTHER IOL OF THE SAME MODEL AND DIOPTER. NO PATIENT INJURY WAS REPORTED, AND NO SURGICAL OR MEDICAL INTERVENTIONS WERE REQUIRED. THE PATIENT¿S OUTCOME OR STATUS IS UNKNOWN. THE PRODUCT, WHICH HAD CONTACT WITH THE PATIENT, WAS DISCARDED AND WILL NOT BE RETURNED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22146517 ↗
• MalfunctionJul 10, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE AR40E INTRAOCULAR LENS (IOL) HAD A DETACHED HAPTIC. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17295299 ↗
• MalfunctionDec 10, 2021Break; Break

  IT WAS REPORTED THAT AFTER IMPLANTING THE INTRAOCULAR LENS (IOL), HAPTIC WAS DEFORMED / DAMAGED AND IOL WAS UNUSABLE. THE LENS WAS IMMEDIATELY REMOVED AND REPLACED IN THE SAME SURGERY. THIS EVENT AFFECTED THE OPERATION PROCESS AND PROLONGED THE OPERATION TIME. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12979032 ↗
• MalfunctionNov 29, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT HAPTIC OF MODEL AR40E SENSAR MONOFOCAL IOL (INTRAOCULAR LENS) WAS OBSERVED AMPUTATED OR DETACHED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Information

  MAUDE report 8114166 ↗
• MalfunctionMar 31, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE AFTER THE IMPLANTATION OF AN INTRAOCULAR LENS (IOL), SMALL ISLAND-SHAPED IRREGULARITIES WHERE NOTICED ON THE LENS AND COULD NOT BE REMOVED. REPORTEDLY, THEY LOOKED LIKE CRINKLED/BROKEN PLASTERS. THE PATIENT WAS NOT AFFECTED. THE LENS REMAINS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6451278 ↗
• InjuryMar 3, 2017Folded; Unintended Movement; Folded; Unintended Movement

  IT WAS REPORTED A CUSTOMER EXPERIENCED PROBLEMS WITH AN AR40E INTRAOCULAR LENS (IOL). IT WAS NOTED THAT THE LENS WAS DEFECTIVE WITH HAPTIC FOLDED. THE IOL WAS DISPLACED AND WAS EXPLANTED. THERE WAS NO DELAY IN THE PROCEDURE. FURTHERMORE, THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION. PATIENT PRE-OPERATORY DETAILS AND PATIENT OUTCOME WAS ALSO NOT AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6375328 ↗