SENSAR IOL AR40M (REF AR40MN0015)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474514232), received between Sep 12, 2020 and Sep 1, 2023 — classified as 1 injury, 3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) HAD A TEAR IN IT. ADDITIONAL INFORMATION RECEIVED STATED THAT THE TEAR WAS NOTICED DURING IMPLANTATION. THE MODEL NUMBER OF CARTRIDGE WAS UNKNOWN. LENS WAS PARTIALLY INSERTED. THERE WERE NO INJURIES AND NO MEDICAL/SURGICAL INTERVENTIONS WERE REQUIRED. THERE WAS NO USE ERROR. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING BACKUP LENS OF SAME MODEL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17672660 ↗
• MalfunctionJan 24, 2022Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD BENT HAPTIC. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13339431 ↗
• MalfunctionFeb 4, 2021Break; Break

  IT WAS REPORTED THAT A AR40M MODEL INTRAOCULAR LENS(IOL) HAD A BROKEN HAPTIC AND WAS NOT IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11277284 ↗
• InjurySep 12, 2020Break; Device Handling Problem; Break; Device Handling Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS FULLY INSERTED AND REMOVED DURING THE SAME-DAY PROCEDURE DUE TO A KINKED HAPTIC. THE LENS WAS DISCARDED. FURTHER INFORMATION WAS REPORTED THAT THE TECHNICIAN LOADED THE LENS IMPROPERLY AND BENT THE HAPTIC. AFTER INSERTION, THE HAPTIC WOULD NOT HOLD IN PLACE, THEREFORE, A REPLACEMENT LENS WAS NEEDED. ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND DIOPTER) WAS IMPLANTED AS A REPLACEMENT. THE INCISION WAS ENLARGED AND ONE SUTURE WAS PLACED IN THE EYE. THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10526037 ↗