SENSAR IOL AR40M (REF AR40MN0005)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474514225), received between Mar 16, 2019 and Dec 19, 2025 — classified as 2 injuries, 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2025Break; Break

  IT WAS REPORTED BY THE CUSTOMER THAT DURING INSERTION, A NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS FOUND WITH A BENT HAPTIC. THE SCRUB TECHNICIAN DID NOT APPLY FORCE, AND THE ISSUE WAS NOT DUE TO USE ERROR. THE LENS WAS REMOVED DURING THE SAME PROCEDURE AND REPLACED WITH A LENS OF THE SAME MODEL AND DIOPTER. NO PATIENT INJURY OR CAPSULE TEAR OCCURRED; ONE 10-0 ETHILON SUTURE WAS REQUIRED. NO MEDICATION BEYOND STANDARD OF CARE WAS ADMINISTERED. THE COMPLAINT DEVICE WAS NOT RETURNED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23857849 ↗
• MalfunctionMay 21, 2025Break; Break

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS DAMAGED DUE TO THE TRAILING HAPTIC WAS SLIGHTLY KINKED AT THE HAPTIC-OPTIC JUNCTION WHICH IMPEDED THE IOL CENTRATION. THE ISSUE WAS NOTICED AFTER THE IOL WAS FULLY IMPLANTED INTO THE PATIENT¿S LEFT EYE. THE IOL WAS REMOVED AND REPLACED WITH A NEW LENS. THERE WAS NO SURGICAL OR MEDICAL INTERVENTION SUCH AS A CAPSULE TEAR, INCISION ENLARGEMENT, VITRECTOMY, OR MEDICATION TO PREVENT PERMANENT IMPAIRMENT. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22058159 ↗
• InjuryJun 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE NON PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 19534184 ↗
• MalfunctionFeb 15, 2022Break; Break

  IT WAS REPORTED THAT THE HAPTIC OF THE INTRAOCULAR LENS (IOL) WAS NOTICED TO BE BENT WHEN THE LENS WAS HALFWAY INTO THE PATIENT'S RIGHT EYE. THE IOL WAS REMOVED AND REPLACED WITH ANOTHER LENS OF SAME MODEL AND DIOPTER AFTER ENLARGING THE INCISION. THERE WAS NO OTHER PATIENT INJURY AND THE PATIENT WAS DOING FINE POST OPERATION. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 13538502 ↗
• InjuryMar 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS WAS EXPLANTED FROM THE RIGHT EYE DUE TO THE PATIENT EXPERIENCING POOR POST-OPERATIVE VISUAL ACUITY. THERE WAS AN INCISION ENLARGEMENT MADE, BUT NO VITRECTOMY WAS PERFORMED. THE REPLACEMENT LENS WAS A DIFFERENT MODEL AR40E 3.5 DIOPTER LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8426999 ↗