SENSAR IOL AR40e (REF AR40E00135)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05050474501973), received between Jan 15, 2021 and Aug 21, 2025 — 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.

• MalfunctionAug 21, 2025Break; Break

  IT WAS REPORTED THAT THE HAPTIC ON THIS LENS BROKE, AND IT WAS REMOVED FROM THE EYE DURING SURGERY AND REPLACED WITH THE SAME MODEL AND DIOPTER LENS DURING THE SAME PROCEDURE. IT WAS NOTICED AFTER IMPLANTATION, DURING POSITIONING. NO INJURY OR INTERVENTION WAS REQUIRED. THE PATIENT IS DOING WELL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22868749 ↗
• MalfunctionAug 21, 2024Break; Break

  IT WAS REPORTED THAT THE HAPTIC OF A MONOFOCAL INTRAOCULAR LENS (IOL) WAS SEEN TO BE BENT ONCE INSERTED INTO A PATIENT'S RIGHT EYE. IT WAS INDICATED THAT THE ISSUE WAS NOT DUE TO USE ERROR. THE LENS WAS REMOVED AND THE SURGERY COMPLETED WITH A BACKUP LENS DURING THE SAME PROCEDURE. A REPLACEMENT LENS OF THE SAME MODEL AND DIOPTER WAS USED. THERE WAS NO UNPLANNED VITRECTOMY REQUIRED AND NO MEDICATION OUTSIDE THE STANDARD OF CARE REQUIRED. IT IS UNKNOWN IF THERE WAS ANY DELAY IN PROCEDURE. THE PATIENT OUTCOME IS UNKNOWN. ADDITIONAL INFORMATION FROM THE DOCTOR INDICATED THAT THERE WAS A DISLOCATION OF THE CRYSTALINE LENS, SO THE LENS AND CAPSULE WERE REMOVED IN TOTAL AND THE IOL WAS PLACED VIA A SCLERAL FIXATED TECHNIQUE WITHOUT SUTURING THE LENS. THE SCLEROTOMY SITES WERE SUTURED. THIS IS STANDARD FOR THIS PROCEDURE. THE CORNEA ALSO HAD A CORNEL SUTURE PLACED WHICH IS ALSO STANDARD. THE PATIENTS VISION IS NOW 20/70 BACK TO HIS BASELINE AND BEST EXPECTED CORRECTED VISUAL ACUITY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20011705 ↗
• MalfunctionAug 8, 2024Break; Break

  IT IS REPORTED THAT THE NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) HAD A BROKEN HAPTIC, AND THERE WAS PATIENT CONTACT. IT WAS STATED THAT THE CATARACT SURGERY WAS COMPLETED BY USING A NON-J&J LENS DURING THE SAME PROCEDURE. NO INJURY OR MEDICAL INTERVENTION WAS REQUIRED. THE CURRENT STATUS OF THE PATIENT REMAINS UNKNOWN. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19945844 ↗
• MalfunctionAug 28, 2023Contamination; Contamination

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS REMOVED FROM THE PATIENT'S LEFT EYE DUE TO DOCTOR COULD NOT REMOVE THE COATING ON THE OPTIC WHICH WAS NOTICED SPLITTING WHEN INJECTING THE LENS. THAT IS THE REASON THAT THE DOCTOR REPLACED THE LENS WITH A NON JOHNSON AND JOHNSON IOL. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES DONE. THE PATIENT FULLY RECOVERED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17632907 ↗
• MalfunctionAug 28, 2023Contamination; Contamination

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS REMOVED FROM THE PATIENT'S LEFT EYE DUE TO DOCTOR COULD NOT REMOVE THE COATING ON THE OPTIC WHICH WAS NOTICED SPLITTING WHEN INJECTING THE LENS. THAT IS THE REASON THAT THE DOCTOR REPLACED THE LENS WITH A NON JOHNSON AND JOHNSON IOL. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES DONE. THE PATIENT FULLY RECOVERED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17632902 ↗
• InjuryFeb 23, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE LAGGING HAPTIC WAS MISSING AND FOUND INSIDE THE INJECTOR DURING THE IMPLANTATION OF THE INTRAOCULAR LENS (IOL) INTO THE PATIENT'S OPERATIVE EYE. LENS WAS FULLY IMPLANTED. HOWEVER, AS THE HAPTIC WAS BROKEN, THE IOL WAS REMOVED DURING THE SAME PROCEDURE. THERE WERE INCISION ENLARGEMENT AND SUTURES PERFORMED. THERE WAS A DELAY IN PROCEDURE OF 20 MINUTES. NO OTHER INTERVENTION WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 13588541 ↗
• MalfunctionMar 4, 2021Break; Break

  IT WAS REPORTED THAT A SENSAR INTRAOCULAR LENS (IOL) WAS REMOVED AND REPLACED WITH ANOTHER LENS OF THE SAME MODEL AND DIOPTER FROM THE PATIENT'S LEFT EYE BECAUSE OF A BENT HAPTIC. THE PATIENT HAS RECOVERED AND NO INJURY WAS REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11408694 ↗
• MalfunctionJan 15, 2021Material Fragmentation

  IT WAS REPORTED THAT THE INTRAOCULAR LENS FAILED DURING INSERTION AND HAD ONE OF ITS HAPTICS AMPUTATED. ANOTHER LENS OF THE SAME MODEL AND DIOPTER WAS USED AS REPLACEMENT TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY/HARM REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11176003 ↗