SENSAR IOL AR40E (REF AR40E00045)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 05050474514089), received between Sep 25, 2018 and Jan 13, 2026 — classified as 7 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2026Material Fragmentation

  IT WAS REPORTED THAT THE NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) TRAILING BACK HAPTIC WAS SEVERED OFF THE LENS DURING INJECTION INTO THE RIGHT EYE. THE LENS WAS FULLY INSERTED BUT SUBSEQUENTLY REMOVED AND REPLACED WITH A BACK-UP LENS DURING THE SAME PROCEDURE. IT IS UNKNOWN IF THE DAMAGE WAS DUE TO USE ERROR. THERE WERE NO UNPLANNED MEDICAL OR SURGICAL INTERVENTIONS, SUCH AS VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES. THE CURRENT PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24052684 ↗
• InjuryNov 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE NON-PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S EYE DUE TO REFRACTIVE SURPRISE. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AND REPLACED WITH A DIB00 LENS WITH 20.0 DIOPTER. THE PATIENT HAD FULLY RECOVERED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 20669472 ↗
• InjuryNov 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SENSAR INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO MECHANICAL COMPLICATIONS/ UNSPECIFIED INJURIES. THERE WAS INCISION ENLARGEMENT, BUT NO VITRECTOMY AND NO SUTURES REQUIRED. ANOTHER JOHNSON & JOHNSON LENS, MODEL AR40M WITH THE SAME DIOPTER AS THE ORIGINAL IOL (4.5 D) WAS USED AS A REPLACEMENT. THE PATIENT TOLERATED THE PROCEDURE WELL. THE SUSPECT PRODUCT WAS DISCARDED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 18235190 ↗
• InjuryJul 7, 2022Break; Break

  IT WAS REPORTED THE INTRAOCULAR LENS (IOL) HAPTIC WAS BENT/BROKEN DURING THE LOADING PROCESS AND WAS FULLY INSERTED IN THE PATIENT'S OPERATIVE EYE. THE IOL WAS REMOVED AND REPLACED WITH THE ANOTHER J&J IOL WITH THE SAME MODEL AND DIOPTER SIZE. UNPLANNED SUTURES WERE REQUIRED INTRA-OPERATIVELY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14951741 ↗
• MalfunctionMay 6, 2022Break; Difficult to Insert; Break; Difficult to Insert

  IT WAS REPORTED AFTER THE INTRAOCULAR LENS (IOL) WAS IN THE PATIENT'S OPERATIVE EYE AND THE SURGEON NOTICED THE HAPTIC WAS MALFORMED BENT AND IT WOULD NOT CENTER IN THE EYE. THE DOCTOR HAD TO CUT THE LENS OUT AND PUT IN THE BACKUP LENS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14312855 ↗
• InjurySep 23, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THERE WAS UNEXPECTED POST-OP RESULTS, WITH POSTOPERATIVE VISUAL ACUITY 0.2 AFTER CORRECTION. IOL WAS EXPLANTED AND REPLACED WITH THE SAME MODEL LENS OF A 1.5 DIOPTER AGAIN.. AFTER CHECKING THE BIOMETRIC VALUES AND CONFIRMING THAT THE LABEL OF THE IMPLANTED LENS WAS 4.5D, THE OPERATOR SUSPECTED THAT THERE WAS A DIFFERENCE IN THE ACTUAL POWER OF THE LENS AND PROPOSED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 12523909 ↗
• MalfunctionSep 7, 2021Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAPTIC WAS BROKEN. THE ISSUE WAS OBSERVED DURING HANDLING PRIOR TO INSERTION. THE LENS WAS FULLY INSERTED AND REMOVED DURING THE SAME PROCEDURE. A BACK UP LENS OF THE SAME MODEL WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT HAS RECOVERED. SUSPECT PRODUCT DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12437091 ↗
• MalfunctionAug 23, 2021Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD BENT HAPTIC. THERE WAS PATIENT CONTACT WITH IOL. THE IOL WAS FULLY INSERTED AND REMOVED DURING THE SAME PROCEDURE. SUSPECT PRODUCT WAS DISCARDED. PATIENT HAS RECOVERED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12355452 ↗
• MalfunctionMay 18, 2021Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS DAMAGED (CUT OUT, NOT IMPLANTED). THERE WAS PATIENT CONTACT WITH THE LENS. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11845963 ↗
• InjuryMay 17, 2021Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS DAMAGED, BROKEN HAPTIC. ADDITIONAL INFORMATION STATES THE LENS WAS COMPLETELY INSERTED AND THEN REMOVED, REPLACED WITH BACK UP LENS AR40E 4.5D SN: (B)(4). THERE WAS NO INCISION ENLARGEMENT AND VITRECTOMY REQUIRED. SUTURES WERE PERFORMED AS PART OF PRODUCT PROBLEM. PATIENT IS STABLE WHEN DISCHARGED. NO OTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11838425 ↗
• MalfunctionMar 10, 2021Break; Break

  IT WAS REPORTED THAT WHILE ADVANCING THE AR40E MODEL INTRAOCULAR LENS(IOL) IN THE EMERALD LOADER THE LEADING HAPTIC GOT BENT AND WAS UNABLE TO SAFELY REMAIN IN THE EYE. THERE WAS PATIENT CONTACT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11449667 ↗
• MalfunctionFeb 17, 2021Material Fragmentation; Device Difficult to Setup or Prepare; Material Fragmentation; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAD TRAILING HAPTIC RIPPED AFTER IMPLANTATION AND EXPLANT WAS PERFORMED. IT WAS STATED THAT THE IOL WAS EXTREMELY RIGID AND VERY DIFFICULT TO LOAD CORRECTLY THROUGH EMERALD CARTRIDGE/INSERTER. THERE WAS PATIENT CONTACT. THE SUSPECT PRODUCT WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11341268 ↗
• InjuryApr 21, 2020Scratched Material; Scratched Material

  IT WAS REPORTED AN INTRAOCULAR LENS (IOL) WAS REMOVED FROM THE PATIENT'S RIGHT (OD) EYE UPON INSERTION BECAUSE THE SURGEON NOTICED A SCRATCH ON THE LENS. THE REPLACEMENT LENS IS THE SAME MODEL AND DIOPTER. AT EXCHANGE, INCISION WAS ENLARGED ALONG WITH SUTURES WERE USED. THE CURRENT PATIENT STATUS WAS REPORTED AS LEFT NORMALLY. THE CUSTOMER ALSO INDICATED THAT THE LENS WAS CUT INTO PIECES AND NOT BEING SENT BACK FOR ANALYSIS. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9982610 ↗
• MalfunctionNov 19, 2018Break; Break

  IT WAS REPORTED THAT THE SURGEON FOUND A DEFECT ON THE HAPTIC OF AN AR40E 4.5 DIOPTER LENS WHILE INSERTING INTO THE PATIENT'S OPERATIVE EYE. THEREFORE, THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS OF THE SAME MODEL AND DIOPTER. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8086163 ↗
• InjurySep 25, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TRAILING HAPTIC OF A MODEL AR40M 4.5 DIOPTER INTRAOCULAR LENS (IOL) WAS NOT THERE ONCE THE LENS WAS IMPLANTED INTO THE PATIENT'S EYE. THE IOL WAS REMOVED AND REPLACED WITH THE BACKUP LENS DURING THE SAME PROCEDURE. AN INCISION ENLARGEMENT WAS REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 7908349 ↗