SENSAR IOL AR40e (REF AR40E00070)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474501898), received between Feb 27, 2019 and Jul 29, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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.

• MalfunctionJul 29, 2022Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED THAT THE HAPTIC OF THE INTRAOCULAR LENS (IOL) BENT WHEN LOADING THE LENS DUE TO LOADER ERROR. THE LENS WAS FULLY INSERTED INTO THE PATIENT'S RIGHT EYE; HOWEVER, THE IOL WAS REMOVED DURING THE SAME PROCEDURE. ANOTHER LENS OF SAME MODEL AND DIOPTER WAS USED AS THE REPLACEMENT IOL. THERE WAS NO PATIENT INJURY REPORTED. THE PATIENT HAS RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15135121 ↗
• InjuryFeb 27, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ONE OF THE HAPTICS OF LENS MODEL, AR40E MONOFOCAL IOL (INTRAOCULAR LENS) HAD TWISTED DURING ITS DEPLOYMENT IN THE ANTERIOR CHAMBER, WHICH MADE THE IMPLANTATION IMPOSSIBLE. IT WAS REMOVED AND REPLACED WITH ANOTHER LENS, WHICH LENGTHENED THE PROCEDURE. THE INCISION HAD TO BE ENLARGED. SUTURES AND VITRECTOMY WERE PERFORMED. THERE WERE NO PATIENT INJURIES NOR ADVERSE EFFECTS WITH SECOND LENS. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available; Vitrectomy

  MAUDE report 8376145 ↗