SENSAR IOL AR40e (REF AR40E00250)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 05050474502208), received between Jul 19, 2017 and Dec 11, 2025 — classified as 3 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 18, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2025Break; Break

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS INSERTED INTO THE PATIENTS EYE AND REMOVED DURING THE SAME PROCEDURE. THE NURSE WAS INFORMED THAT THE PRODUCT MADE CONTACT WITH THE PATIENT. HOWEVER, THE IOL WAS DAMAGED. THE LENS WAS REPLACED WITH A BACKUP OF THE SAME MODEL AND DIOPTER. NO FURTHER INFORMATION IS AVAILABLE REGARDING THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23785314 ↗
• MalfunctionJun 11, 2025Break; Use of Device Problem; Break; Use of Device Problem

  THE SURGERY CENTER REPORTED BACK HAPTIC ALL TWISTED UP COMING OUT WITH A MONOFOCAL INTRAOCULAR LENS (IOL). THEY ALSO REPORTED LOADING ERROR. THERE WAS PATIENT CONTACT AND THE LENS WAS PLACED IN THE EYE. THE ISSUE WAS NOTED AFTER IMPLANTATION OF THE LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22189339 ↗
• MalfunctionApr 29, 2025Break; Break

  IT WAS REPORTED THAT A PRELOADED INTRAOCULAR LENS (IOL) HAS FAILED TO BE IMPLANTED AS ONE OF THE HAPTIC WAS BROKEN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21931517 ↗
• MalfunctionMar 18, 2022Break; Break

  IT WAS REPORTED THE INTRAOCULAR LENS (IOL) HAPTIC WAS BROKEN/TORN; THE EXTENT OF PATIENT CONTACT IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13804116 ↗
• MalfunctionJan 18, 2022Break; Break

  IT WAS REPORTED THAT AFTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE EYE, THE HAPTIC WAS FRACTURED. IOL WAS REMOVED AND REPLACED. THE SURGERY WENT SMOOTHLY. PRODUCT RETURN NOT AVAILABLE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13286847 ↗
• MalfunctionJul 28, 2021Break; Break

  IT WAS REPORTED THAT A AR40E MODEL INTRAOCULAR LENS(IOL) HAD HAPTIC BROKE DURING MANIPULATION. ADDITIONAL DETAILS RECEIVED STATES THAT THE LENS BROKE DURING THE LOADING PROCESS AND WAS INSERTED INTO THE EYE. THE HAPTIC WAS NOTICED THAT IT WAS INDEED BROKEN ONCE THE LENS WAS INSERTED INTO THE EYE. THE DOCTOR HAD TO CUT THE LENS OUT OF THE EYE AND PROCEDURE WAS COMPLETED SUCCESSFULLY USING BACKUP LENS OF SAME MODEL AND DIOPTER. THERE WAS NO INJURY TO THE PATIENT AND NO MEDICAL/SURGICAL INTERVENTION SUCH AS INCISION ENLARGEMENT, VITRECTOMY OR SUTURES WERE REQUIRED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12236262 ↗
• MalfunctionJul 8, 2021Break; Break

  IT WAS REPORTED THAT DURING INTRAOCULAR LENS INJECTION, IT WAS FOUND THAT THE INTRAOCULAR LENS HAPTIC WAS BROKEN AND COULD NOT BE IMPLANTED. A NEW INTRAOCULAR LENS WAS USED AND THE SURGERY WAS UNEVENTFUL. PRODUCT NOT AVAILABLE FOR RETURN. IT IS UNCLEAR IF ISSUE OCCURRED WITH PATIENT CONTACT OR NOT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12133286 ↗
• InjuryApr 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INITIALLY THERE WAS LOADING ERROR WITH SENSAR MONOFOCAL INTRAOCULAR LENS, SO SURGEON THOUGHT OF USING SENSAR MONOFOCAL INTRAOCULAR LENS WITH SAME MODEL AND SAME DIOPTER (MODEL AR40E +25.0 DIOPTER). HOWEVER, THIS LENS HAD BROKEN HAPTIC DURING SURGERY. SO, SURGEON IMPLANTED INITIAL LENS SUCCESSFULLY USING FORCEPS BY HAND AND NO CARTRIDGE WAS USED. DURING THE SAME PROCEDURE AN INCISION ENLARGEMENT AND SUTURES WERE REQUIRED. NO FURTHER INFORMATION PROVIDED. THIS REPORT WILL CAPTURE INFORMATION FOR LENS THAT REMAINS IMPLANTED. A SEPARATE REPORT IS BEING SUBMITTED FOR LENS THAT HAD A BROKEN HAPTIC ISSUE.

  Patient problems: No Code Available

  MAUDE report 8512879 ↗
• InjuryApr 13, 2019Break; Break

  IT WAS REPORTED THAT INITIALLY THERE WAS LOADING ERROR WITH SENSAR MONOFOCAL INTRAOCULAR LENS, SO SURGEON THOUGHT OF USING SENSAR MONOFOCAL INTRAOCULAR LENS WITH SAME MODEL AND SAME DIOPTER (MODEL AR40E +25.0 DIOPTER). HOWEVER, THIS LENS HAD BROKEN HAPTIC DURING SURGERY. SO, SURGEON IMPLANTED INITIAL LENS SUCCESSFULLY USING FORCEPS BY HAND AND NO CARTRIDGE WAS USED. DURING THE SAME PROCEDURE INCISION ENLARGEMENT AND SUTURES WERE REQUIRED. NO FURTHER INFORMATION PROVIDED. THIS REPORT WILL CAPTURE INFORMATION FOR BROKEN HAPTIC ISSUE. ANOTHER REPORT IS BEING SUBMITTED FOR LENS THAT REMAINS IMPLANTED.

  Patient problems: No Code Available

  MAUDE report 8512000 ↗
• MalfunctionAug 9, 2017Break; Break

  IT WAS REPORTED THAT DURING INSERTION INTO THE EYE, AN INTRAOCULAR LENS (IOL) WAS NOTICED BROKEN. PATIENT CONTACT WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6780060 ↗
• MalfunctionAug 9, 2017Break; Break

  IT WAS REPORTED THAT DURING INSERTION INTO THE EYE, AN INTRAOCULAR LENS (IOL) WAS NOTICED BROKEN. PATIENT CONTACT WAS REPORTED. REPORTEDLY, THE LENS WAS NOT IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6778811 ↗
• InjuryJul 19, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A AR40E 25.0 DIOPTER INTRAOCULAR LENS (IOL) WAS INSERTED AND REMOVED FROM A FEMALE PATIENT'S RIGHT EYE. ACCORDING TO THE PHYSICIAN THE LENS WAS FOLDED AND CHECKED BY TECHNICIAN AND REPRESENTATIVE. UPON ATTEMPT TO IMPLANT THE PHYSICIAN NOTICED THE EYE FILLED WITH BLOOD, IOL WAS REMOVED AND COULD NOT BE USED DUE TO THE PATIENT'S EYE. THROUGH FOLLOW-UP IT WAS LEARNED THAT THE DOCTOR POSSIBLY NICKED THE IRIS OR OTHER PARTS OF THE EYE WHILE DISSECTING BACK CONJUNCTIVA AND MAKING A HOLE IN THE SCLERA. THE LENS HAD NOTHING TO DO WITH THIS PART OF THE PROCEDURE. IOL WAS REMOVED AS A WHOLE. NO ISSUE WITH IOL, PATIENT ANATOMY AND COMPLICATION WITH PROCEDURE LED TO REMOVAL OF THE PERFECTLY IMPLANTED LENS. AT REMOVAL THE INCISION WAS ENLARGED AND SUTURED. THERE WAS NO VITRECTOMY. THE REASON THE PATIENT WAS THERE WAS BECAUSE THEY HAD ALREADY HAD A VITRECTOMY FROM A PREVIOUS SURGICAL COMPLICATION. PATIENT HAD NO ¿BAG¿ FOR NORMAL LENS PLACEMENT AND SO THE PHYSICIAN WAS TRYING TO SEW IN A LENS FOR THE PATIENT.

  Patient problems: No Code Available

  MAUDE report 6724072 ↗