SENSAR IOL AR40e (REF AR40E00145)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05050474501997), received between Feb 3, 2021 and Oct 13, 2025 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 13, 2025Break; Break

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS INSERTED INTO THE PATIENT¿S EYE AND THEN REMOVED DUE TO THE TRAILING HAPTIC WAS BROKEN. A BACKUP IOL OF THE SAME MODEL WAS USED TO COMPLETE THE PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23275919 ↗
• InjuryMar 25, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, A DOCTOR INADVERTENTLY INSERTED A NON-PRELOADED LENS INTO THE EYE IN A PARTIALLY BACKWARDS ORIENTATION, WHICH CAUSED A PROBLEM WHERE THE LENS WAS NOT RELEASED, NECESSITATING THE REMOVAL OF BOTH THE LENS AND THE INSERTER. THE LENS WAS NOT RELEASED INTO THE EYE BUT UNPLANNED SUTURES WERE REQUIRED. THERE WERE NO INJURIES TO THE PATIENT. THE PATIENT IS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21690003 ↗
• MalfunctionSep 27, 2024Use of Device Problem; Scratched Material; Use of Device Problem; Scratched Material

  IT WAS REPORTED THAT A MONOFOCAL INTRAOCULAR LENS (IOL) WAS SCRATCHED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20317416 ↗
• MalfunctionDec 13, 2023Break; Break

  IT WAS REPORTED THAT INTRAOCULAR LENS HAD BENT HAPTIC. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18322887 ↗
• InjuryJan 14, 2022Break; Difficult to Insert; Break; Difficult to Insert

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS NOT POSITIONING CORRECTLY INSIDE THE PATIENT'S RIGHT EYE. ADDITIONAL INFORMATION REVEALED THAT AN ATTEMPT WAS MADE TO PERFORM A YAMANE INTRASCLERAL HAPTIC FIXATION. THE TRAILING HAPTIC WAS UNABLE TO BE PASSED INTO THE TSK NEEDLE AS IT WOULD NOT FIT PROPERLY. AFTER MULTIPLE ATTEMPTS THE HAPTIC WAS KINKED AND THE DECISION WAS MADE TO EXPLANT. THIS WAS THE SECOND ATTEMPT MADE TO FIXATE AN IOL AND DUE TO THE DURATION OF SURGERY THE PATIENT WAS LEFT APHAKIC. THE INCISION WAS ENLARGED TO REMOVE THE LENS DURING THE SAME PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED. THE PATIENT IS BEING MONITORED WITH PLAN FOR A FUTURE PARS PLAN VITRECTOMY AND SECONDARY IOL. THE REMOVED LENS WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 13256968 ↗
• InjuryMay 26, 2021Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS INSERTED AND REMOVED DURING THE SAME PROCEDURE FROM THE PATIENT'S LEFT EYE DUE TO HAPTIC TORN. THERE WAS INCISION ENLARGEMENT AND VITRECTOMY. BACK-UP LENS WAS USED INSTEAD. THE SUSPECT PRODUCT HAS BEEN DISCARDED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11886399 ↗
• MalfunctionFeb 3, 2021Break; Break

  IT WAS REPORTED THAT A SENSAR INTRAOCULAR LENS (IOL) WAS FULLY INSERTED AND DOCTOR NOTICED THAT THE HAPTIC WAS KINKED AND DECIDED TO REMOVE THE LENS FROM THE PATIENT'S RIGHT (OD) EYE DURING THE SAME PROCEDURE. THE LENS WAS CUT OUT AND DISPOSED OF. REPORTEDLY, THERE WAS NO ADDITIONAL SURGICAL INTERVENTION REQUIRED AND THE PATIENT IS DOING FINE POST-OPERATION. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11275615 ↗