SENSAR IOL AR40e (REF AR40E00115)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474514157), received between Jan 24, 2025 and Mar 23, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 23, 2026Break

  IT WAS REPORTED THAT UPON INSERTION OF A THREE PIECE NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) IN THE PATIENT'S RIGHT EYE, IT WAS OBSERVED THAT THE HAPTIC WAS BROKEN. THE IOL WAS NOT INSERTED BUT THE CARTRIDGE TIP MADE CONTACT WITH THE EYE. ACCOUNT INDICATED THAT DAILY ACTIVITIES WERE NOT AFFECTED AND NO UNPLANNED SURGICAL INTERVENTIONS SUCH AS, INCISION ENLARGEMENT, SUTURES, OR VITRECTOMY WERE REQUIRED. PATIENT OUTCOME WAS UNKNOWN. THERE WAS NO PATIENT INJURY REPORTED. IT IS UNKNOWN WHETHER A USE ERROR OCCURRED OR WHETHER FORCE WAS APPLIED DURING DELIVERY OF THE IOL. THE PROCEDURE WAS COMPLETED USING A BACKUP LENS; HOWEVER, THE MODEL IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24670977 ↗
• InjuryJan 24, 2025Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED THAT THE NON-PRELOADED INTRAOCULAR LENS (IOL) WAS WASTED, VITRECTOMY WAS PERFORMED. THERE WAS PATIENT CONTACT. IT WAS NOTED THAT THE LENS WAS NOT REMOVED IN A SECONDARY PROCEDURE. THE LENS IS NOT AVAILABLE TO BE RETURNED. NO FURTHER INFORMATION WAS PROVIDED. THROUGH FOLLOW UP, IT WAS LEARNED THAT WASTED MEANT THE SURGEON NOTED A HAPTIC BROKE WHILE IN THE INJECTOR. THERE WAS A LOADING ISSUE. IT WAS UNKNOWN IF THERE WAS PATIENT CONTACT OR THE EXTENT OF PATIENT CONTACT. ALL THAT WAS PROVIDED WAS LENS WAS NOT INSERTED. IT WAS UNKNOWN IF THE VITRECTOMY WAS PERFORMED PRIOR TO PATIENT CONTACT OR AFTER PATIENT CONTACT. IT WAS UNKNOWN IF THERE WAS PATIENT INJURY. A DIFFERENT LENS WAS INSERTED. THE LENS IS NOT AVAILABLE FOR RETURN. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 21233825 ↗