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SENSAR IOL AR40M (REF AR40M00005)Recalls & reported problems

Johnson & Johnson Surgical Vision, Inc. · ACRY 13.5mm 6 OPT MOD C PMMA OPTIEDGE · Class 3 · Implant

All models of SENSAR IOL (112)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
4
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474514201), received between Jan 3, 2018 and May 3, 2021 — classified as 2 injuries, 2 malfunctions.

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

Device problems

  • Break2
  • Adverse Event Without Identified Device or Use Problem1
  • Device Difficult to Setup or Prepare1
  • Torn Material1
  • Use of Device Problem1

Patient problems

  • No Code Available2
  • No Clinical Signs, Symptoms or Conditions1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 3, 2021Break; Device Difficult to Setup or Prepare; Use of Device Problem; Break; Device Difficult to Setup or Prepare; Use of Device Problem

    IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAD LOADING ISSUE AND THE TECHNICIAN STRUGGLED CAUSING DAMAGE TO THE LENS. THE LENS WAS FULLY INSERTED INTO PATIENT'S RIGHT EYE AND WAS REMOVED AND REPLACED IN THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER LENS OF SAME MODEL AND DIOPTER. THE PATIENT IS DOING WELL. THE EVENT WAS OBSERVED AFTER INSERTION. NO FURTHER INFORMATION IS AVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11766850 ↗
  • InjurySep 16, 2020Break; Break

    IT WAS REPORTED INTRAOCULAR LENS (IOL) WAS FULLY INSERTED IN THE PATIENT¿S OPERATIVE EYE AND REMOVED DUE TO BROKEN HAPTIC. THE INCISION WAS ENLARGED AND THERE WAS NO PATIENT INJURY. ANOTHER LENS WITH THE SAME MODEL WAS IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Code Available

    MAUDE report 10541340 ↗
  • InjurySep 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A AR40M INTRAOCULAR LENS (IOL) WAS REMOVED AND REPLACED DURING THE INITIAL PROCEDURE BECAUSE OF A LOADING ERROR. SURGICAL INTERVENTION WAS PERFORMED AND SUTURES WERE USED TO CLOSE THE LARGER INCISION. REPORTEDLY, THERE WAS NO HARM TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

    Patient problems: No Code Available

    MAUDE report 8976061 ↗
  • MalfunctionJan 3, 2018Torn Material; Torn Material

    IT WAS REPORTED THAT THE INTRAOCULAR LENS WAS OBSERVED TORN. REPORTEDLY, THE LENS WAS TORN DURING HANDLING; PRIOR TO INSERTION, HOWEVER, THIS WAS NOT CONFIRMED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7161393 ↗

Other intraocular lens devices

All intraocular lens devices →

Sources and updates

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