SENSAR IOL AR40E (REF AR40E00055)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05050474514096), received between Dec 22, 2018 and Jul 7, 2025 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 2025Break; Break

  IT WAS REPORTED THAT THE HAPTICS OF THE INTRAOCULAR LENS BENT WHEN ATTEMPTING TO INSERT THE LENS INTO THE EYE. THIS WAS NOTICED DURING THE INSERTION. THE PROCEDURE WAS COMPLETED WITH THE SAME MODEL AND DIOPTER LENS. THERE WAS NO INJURY, AND NO FURTHER INTERVENTION WAS REQUIRED. THE PATIENT¿S OUTCOME IS SATISFACTORY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22414343 ↗
• MalfunctionAug 22, 2023Break; Break

  IT WAS REPORTED THAT THE THREE-PIECE MONOFOCAL INTRAOCULAR LENS (IOL) HAD A BROKEN LEADING HAPTIC WHICH WAS NOTICED AFTER IMPLANTATION/APPLICATION IN THE PATIENTS RIGHT EYE. THE LENS WAS INSERTED AND REMOVED DURING SAME PROCEDURE. ADDITIONAL INFORMATION STATED THAT THERE WAS NO INJURY AND NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. PATIENT IS DOING GOOD. THE PROCEDURE WAS COMPLETED USING COMPETITOR BACKUP LENS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17600131 ↗
• MalfunctionJul 19, 2023Break; Break

  IT WAS REPORTED AFTER THE NON-PRELOADED AR40E MODEL INTRAOCULAR LENS (IOL) WAS FULLY INSERTED INTO THE PATIENT¿S OCULAR DEXTER (RIGHT EYE) THE HAPTIC BROKE. THE SUSPECT IOL WAS REMOVED AND ANOTHER LENS WITH THE SAME MODEL DIOPTER SIZE WAS IMPLANTED. THERE WAS NO PATIENT INJURY, NO MEDICAL INTERVENTION, AND NO SURGICAL INTERVENTION. PATIENT STATUS POST-PROCEDURE WAS REPORTED AS DOING FINE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17352928 ↗
• MalfunctionApr 14, 2020Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS WAS CRACKED AND HAD TO BE CUT OUT AND REPLACED WITH ANOTHER LENS OF THE SAME MODEL. THERE WAS A DELAY IN THE PROCEDURE BUT NO SUTURES OR VITRECTOMY WERE REQUIRED. REQUESTS WERE MADE FOR ADDITIONAL INFORMATION BUT NO RESPONSE HAS BEEN RECEIVED. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9960959 ↗
• InjuryJan 16, 2019Material Twisted/Bent; Material Twisted/Bent

  WHEN INSERTING THE AR40E 5.5 DIOPTER INTRAOCULAR LENS (IOL) INTO THE PATIENT'S OPERATIVE EYE, IT WAS REPORTED THAT THE HAPTIC WAS BENT AND WOULD NOT UNBEND IN THE EYE. REPORTEDLY, THE LENS HAD TO BE CUT OUT OF THE EYE. AN INCISION ENLARGEMENT WAS REQUIRED AND SUTURES WERE USED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A BACK-UP LENS WITH THE SAME MODEL AND DIOPTER SIZE. THE PATIENT OUTCOME WAS REPORTED AS FINE. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 8251980 ↗
• MalfunctionDec 22, 2018Break; Break

  IT WAS REPORTED THAT INTRAOCULAR LENS HAD BENT HAPTIC AND WAS STUCK IN CARTRIDGE. THERE WAS PATIENT CONTACT WITH THE LENS. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. PATIENT WAS FINE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8192844 ↗