SENSAR IOL AR40e (REF AR40E00120)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05050474501942), received between Oct 25, 2018 and May 20, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2026Break; Ejection Problem

  IT WAS REPORTED THAT THREE PIECE MONOFOCAL NON-PRELOADED INTRAOCULAR LENS (IOL) WAS STUCK AND HAPTIC WAS BROKEN. LENS WAS PARTIALLY INSERTED. LENS WAS REMOVED IN SAME PROCEDURE. THERE WAS NO NEED FOR UNPLANNED INCISION ENLARGEMENT, SUTURES, OR VITRECTOMY, AND NO ADDITIONAL MEDICAL ATTENTION OR MEDICATION WAS REQUIRED BEYOND STANDARD CARE. THERE WAS DELAY IN PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25233473 ↗
• MalfunctionMay 8, 2026Break

  IT WAS REPORTED THAT A THREE-PIECE, NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS NOTED AS DEFECTIVE AND WAS NOT USED DUE TO AN OBSERVED BAD HAPTIC. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25120504 ↗
• MalfunctionMay 4, 2026Material Fragmentation; Ejection Problem

  IT WAS REPORTED THAT THE PHYSICIAN FOLDED A NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) AND INITIATED INSERTION WHEN THE HAPTIC BROKE OFF. THE LENS WAS PARTIALLY INSERTED AT THE TIME OF THE EVENT. THE DEVICE WAS REMOVED WITHOUT THE NEED FOR UNPLANNED INCISION ENLARGEMENT, SUTURES, OR ADDITIONAL MEDICAL TREATMENT BEYOND STANDARD OF CARE. THERE WAS NO PROCEDURAL DELAY, AND THE DIRECTIONS FOR USE WERE FOLLOWED. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED. THE ISSUE REPORTED WITH TWO LENSES; THIS REPORT PERTAINS TO ONE OF THE TWO. A SEPARATE REPORT WAS SUBMITTED FOR THE OTHER LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25075997 ↗
• MalfunctionApr 28, 2026Material Fragmentation; Ejection Problem

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS FOLDED BY THE DOCTOR. AS THE DOCTOR BEGAN INSERTING THE LENS INTO THE PATIENT¿S EYE, THE LENS MADE IT PARTIALLY INTO THE EYE BEFORE THE HAPTIC WAS STUCK IN THE CARTRIDGE. THE IOL WAS REMOVED AND A NEW LENS WAS INSERTED. REPORTEDLY, THE DIRECTIONS FOR USE WERE FOLLOWED. THERE WAS NO UNPLANNED INCISION ENLARGEMENT, SUTURES, OR VITRECTOMY REQUIRED. NO MEDICATION OUTSIDE THE STANDARD OF CARE. THE PATIENT OUTCOME IS REPORTED AS ¿UNKNOWN¿. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25024120 ↗
• MalfunctionJul 31, 2025Break; Break

  IT WAS REPORTED BY THE CUSTOMER THAT A LENS WAS DISCARDED IN THE OPERATING ROOM DUE TO DAMAGE TO THE HAPTICS FROM MANIPULATION. THE SURGEON UTILIZED A BACKUP LENS INSTEAD. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22679636 ↗
• MalfunctionMay 23, 2024Break; Break

  IT WAS REPORTED THAT THERE WAS A FAULTY NON PRELOADED INTRAOCULAR LENS DUE TO BENT HAPTIC WHICH WAS NOTICED DURING IMPLANTATION. LENS WAS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19388823 ↗
• InjuryJul 23, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ON (B)(6) 2019, AFTER THE INTRAOCULAR LENS (IOL), MODEL AR40E 12.0 DIOPTER WAS IMPLANTED USING THE OUT THE BAG (EXTRA CAPSULAR FIXATION) PROCEDURE, THE LENS WAS NOT STABLE IN THE EYE. IT WAS INDICATED THAT THE LENS WAS EXPLANTED AND REPLACED WITH A COMPETITOR'S LENS. THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: No Code Available

  MAUDE report 8814799 ↗
• MalfunctionOct 25, 2018Physical Resistance/Sticking; Separation Problem; Physical Resistance/Sticking; Separation Problem

  IT WAS REPORTED THAT HAPTIC OF MODEL AR40E SENSAR MONOFOCAL IOL (INTRAOCULAR LENS) WAS OBSERVED DETACH AT THE TIME OF IMPLANTATION AS IT REMAINED STUCK IN THE CARTRIDGE. IT WAS ALSO INDICATED THE SURGERY WAS TERMINATED TO AVOID THE RISK OF EXPLANTING. THERE WAS NO ISSUE AFTER SURGERY, NO PATIENT INJURY. DETACHED HAPTIC WILL BE RETURNED FOR INVESTIGATION. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8005943 ↗