SENSAR IOL AR40e (REF AR40E00230)Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 05050474502161), received between Nov 1, 2016 and Jun 9, 2026 — classified as 10 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Break” (24 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2026Break

  IT WAS REPORTED THAT A MONOFOCAL INTRAOCULAR LENS (IOL) WAS INSERTED IN THE PATIENT'S OPERATIVE EYE AND REMOVED DURING THE SAME PROCEDURE DUE TO A DEFECTIVE LENS. THE PATIENT FULLY RECOVERED, AND THERE WAS NO ENLARGEMENT OF THE INCISION, NO SUTURES REQUIRED, NO VITRECTOMY PERFORMED, AND NO DELAY IN THE PROCEDURE. THE INSTRUCTIONS FOR USE WERE FOLLOWED. THE LENS WAS DISCARDED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25439368 ↗
• MalfunctionFeb 12, 2026Break

  IT WAS REPORTED THAT INTRAOCULAR LENS (IOL) WAS UNABLE TO STAY IN THE SULCUS AFTER IOL WAS IMPLANTED FULLY INTO THE EYE BECAUSE THE HAPTIC WAS KINKED. IOL WAS REMOVED AND REPLACED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24325011 ↗
• MalfunctionOct 15, 2025Break; Break

  IT WAS REPORTED THAT THE STANDALONE INTRAOCULAR LENS (IOL) WAS DEFECTIVE AND NOT IMPLANTED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23287670 ↗
• MalfunctionJun 23, 2025Break; Break

  IT WAS REPORTED THAT A MONOFOCAL INTRAOCULAR LENS (IOL) HAPTIC BROKE WHEN THE SURGEON ATTEMPTED TO INSERT THE LENS INTO THE PATIENT'S OPERATIVE EYE. ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND DIOPTER) WAS IMPLANTED AS A REPLACEMENT. THE REPORT INDICATES THAT THERE WAS PATIENT CONTACT DURING THE INCIDENT. THROUGH FOLLOW UP, IT WAS LEARNED THE LENS WAS FULLY INSERTED AND REMOVED FROM THE PATIENT'S LEFT EYE IN THE SAME PROCEDURE. A SLIGHT INCISION ENLARGEMENT WAS REQUIRED, HOWEVER, THERE WERE NO OTHER ISSUES. THERE WAS A DELAY IN PROCEDURE. THE LENGTH OF THE DELAY WAS NOT SPECIFIED. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION OUTSIDE OF THE STANDARD CARE REQUIRED. THE PATIENT HAS FULLY RECOVERED. THE LENS WAS CUT TO REMOVE FROM THE EYE, SO THE LENS IS NOT AVAILABLE TO RETURN, HOWEVER, THE DELIVERY DEVICE IS AVAILABLE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 22311226 ↗
• InjuryJun 2, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT WHILE IMPLANTING THE NON-PRELOADED LENS (IOL) INTO PATIENT'S LEFT EYE, THE LENS WAS NOT CENTERING AND THEN THE CAPSULE RUPTURED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Capsular Bag Tear

  MAUDE report 22127214 ↗
• InjuryMar 24, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AFTER IMPLANTATION OF THE INTRAOCULAR LENS (IOL) IN THE SULCUS, IT WAS OBSERVED THAT THE LENS TENDED TO SLIP INTO THE VITREOUS CAVITY. THEREFORE, REMOVAL OF THE IOL WAS NECESSARY. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 21684069 ↗
• InjuryNov 18, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT HAD A NON-PRELOADED LENS IMPLANTED ON OCTOBER 15TH, WHICH DISLOCATED ONE DAY POST-OP. ON THE 22ND, WHEN THE DOCTOR WENT IN NOTICED A BENT HAPTIC, REQUIRING REMOVAL AND REPLACEMENT OF THE LENS. A NEW IOL OF THE SAME MODEL AND DIOPTER WAS IMPLANTED DURING THE SAME PROCEDURE. NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 20716112 ↗
• MalfunctionAug 22, 2024Break; Break

  IT WAS REPORTED THAT THE TRAILING HAPTIC BECAME LOOSE HALFWAY THROUGH INSERTION, NECESSITATING THE SURGEON TO REMOVE IT AND UTILIZE THE BACKUP LENS. ADDITIONAL INFORMATION SUGGESTS THAT THE PROBLEM WAS NOTICED DURING THE IMPLANTATION/APPLICATION, AND THE LENS WAS PARTIALLY IMPLANTED. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20039923 ↗
• MalfunctionMay 7, 2024Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS DEFECTIVE. NO FURTHER INFORMATION HAS BEEN SHARED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19265378 ↗
• InjuryMay 7, 2024Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED THAT THE NON PRELOADED INTRAOCULAR LENS WAS (IOL) WAS LOADED AND INSERTED INTO THE LEFT EYE OF THE PATIENT. BUT UPON INSERTION IT WAS NOTED THAT THE TRAILING HAPTIC WAS BENT. WHILE GETTING THE IOL INTO PLACE, AND WHILE REMOVING THE IOL, THE POSTERIOR CAPSULE WAS PUNCTURED AND A VITRECTOMY WAS REQUIRED. A BACKUP IOL OF THE SAME MODEL AND DIOPTER WAS IMPLANTED. TWO SUTURES WERE PERFORMED TO CLOSE THE MAIN INCISION AND THE PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. THE PATIENT WAS SENT TO RETINA SPECIALIST THE FOLLOWING DAY FOR EVALUATION AS THE SECOND IOL WAS NOT STABLE. THE INSERTER USED WAS AN EMERALD SERIES. BALANCED SALT SOLUTION (BSS) WAS USED AS A CARTRIDGE LUBRICANT AT ROOM TEMPERATURE. ACCOUNT STATED THAT THERE WAS A LOADING ERROR AS THE TECH DID NOT SEE THAT THE TRAILING HAPTIC WAS NOT PLACED PROPERLY BEFORE ADVANCING THE IOL. THE PATIENT WAS STABLE AND THE IOL WAS SAFELY REMOVED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Bag Tear

  MAUDE report 19265062 ↗
• MalfunctionJan 9, 2024Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS DEFECTIVE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18478801 ↗
• MalfunctionAug 2, 2023Material Opacification; Material Opacification

  IT WAS REPORTED THAT THERE WAS A WHITE DEPOSIT ON THE INTRAOCULAR LENS (IOL) AND IT WAS INTRODUCED INTO THE PATIENT'S EYE AS LENS WAS BEING IMPLANTED. THE IOL WAS REMOVED FROM THE PATIENT'S EYE. THERE WAS NO DELAY IN TREATMENT OR OTHER INTERVENTIONS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17446987 ↗
• MalfunctionJul 31, 2023Break; Break

  IT WAS REPORTED THAT THE HAPTICS OF THE INTRAOCULAR LENS (IOL) WERE BENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17431199 ↗
• MalfunctionJun 20, 2023Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) MODEL AR40E WAS DEFECTIVE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17167692 ↗
• MalfunctionMay 23, 2023Break; Break

  IT WAS REPORTED THAT A TEAR OR DIVOT WAS NOTICED IN THE POSTERIOR SURFACE OF THE CENTRAL OPTIC OF AN INTRAOCULAR LENS (IOL). THERE WAS PATIENT CONTACT. INCISION WAS ENLARGED FOR LENS REMOVAL AND SUTURES WERE PLACED. ANOTHER LENS WITH THE SAME MODEL AND DIOPTER WAS IMPLANTED IN THE PATIENT'S RIGHT EYE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16989896 ↗
• MalfunctionNov 14, 2022Break; Break

  IT WAS REPORTED THAT WHEN IMPLANTING THE INTRAOCULAR LENS (IOL), IT WAS NOTED THAT THE HAPTIC WAS BROKEN. THE LENS WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15795009 ↗
• MalfunctionSep 14, 2022Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAPTIC WAS DAMAGED. THROUGH FOLLOW UP, IT WAS CONFIRMED THAT THE CARTRIDGE TIP AND LENS WAS IN CONTACT WITH THE EYE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15422560 ↗
• MalfunctionAug 3, 2022Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAD A HANDLE THAT WAS DAMAGED. THE ISSUE WAS OBSERVED DURING IMPLANTATION. THE IOL WAS REPLACED WITH ANOTHER LENS OF THE SAME MODEL AND DIOPTER. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15160824 ↗
• MalfunctionJul 26, 2022Scratched Material; Scratched Material

  IT WAS REPORTED THAT A 3 PIECE AR40E INTRAOCULAR LENS (IOL) WAS REMOVED AND REPLACED WITH ANOTHER ONE DUE TO BEING MARKED IN THE OPTICAL ZONE DURING INSERTION INTO THE PATIENT'S OPERATIVE EYE. THE ISSUE WAS OBSERVED IN THE POSTOPERATIVE EXAM AND THE DOCTOR SUSPECTS THAT IT MAY BE A MARKING CAUSED BY THE CARTRIDGE. THERE WAS NO VITRECTOMY REQUIRED AND NO DELAY IN PROCEDURE REPORTED. THE PATIENT'S DAILY ACTIVITIES WERE NOT SIGNIFICANTLY AFFECTED AND THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR THE INTRAOCULAR LENS, MODEL AR40E. SEPARATE REPORTS ARE BEING SUBMITTED FOR THE OTHER REPORTED INTRAOCULAR LENSES AND CARTRIDGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15108906 ↗
• MalfunctionJun 8, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT THE HAPTICS OF THE INTRAOCULAR LENS (IOL) DID NOT UNFOLD POST IMPLANTATION IN THE PATIENT'S SURGICAL EYE. THE LENS WAS IMPLANTED AND REMOVED DURING THE SAME PROCEDURE AFTER THE SURGEON REALIZED THAT THE IOL WAS NOT UNFOLDING CORRECTLY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, NO FURTHER MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14632212 ↗
• InjuryMay 25, 2022Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS DEFECTIVE AND THAT THE SURGEON EXPLANTED IT BECAUSE THE POSTERIOR CHAMBER BROKE. THROUGH FOLLOW-UP, IT WAS LEARNT THAT THERE WAS A RUPTURE OF THE POSTERIOR CHAMBER AND THE LENS WAS REMOVED DURING THE INITIAL PROCEDURE, BECAUSE THERE WAS LACK OF SUPPORT. NEITHER THE LENS NOR ANY OTHER JOHNSON & JOHNSON DEVICE IS REPORTED TO HAVE CAUSED OR CONTRIBUTED TO THE CAPSULE TEAR AND THE SURGERY COULD NOT BE COMPLETED WITH A BACK-UP LENS. HOWEVER, THIS COULD NOT BE VERIFIED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 14493535 ↗
• MalfunctionApr 8, 2022Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS DEFECTIVE AND EXPLANTED. THE CORRESPONDENCE INDICATED THAT AN IOL OF THE SAME MODEL AND DIOPTER WAS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14062788 ↗
• MalfunctionOct 29, 2020Break; Break

  THIS REPORT SUMMARIZES <NOE> 16 </NOE> MALFUNCTION EVENTS. THE EVENTS WERE RELATED TO LENS DAMAGE. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10753189 ↗
• InjurySep 11, 2020Break; Break

  IT WAS REPORTED THAT AFTER THE SENSAR MONOFOCAL INTRAOCULAR LENS (IOL) WAS CORRECTLY POSITIONED IN THE INJECTOR, THE HAPTIC DID NOT DEPLOY BUT STAYED OVER THE OPTIC WHEN POSITIONED INSIDE THE CAPSULAR BAG OF THE PATIENT'S RIGHT (OD) EYE. IT WAS BROKEN AND THE SURGEON HAD EXTRACTED THE LENS IMMEDIATELY. INCISION WAS ENLARGED AND ONE SUTURE POINT WAS USED. THE CUSTOMER INDICATED THAT THEY WERE NOT CERTAIN IF IT IS THE MANIPULATION OF THE INJECTOR OR POSITION OF THE LENS IN THE CARTRIDGE (INJECTOR) THAT MAY ATTRIBUTED TO THE EVENT. THERE WAS NO INJURY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10519404 ↗
• InjuryJul 15, 2020Break; Break

  IT WAS INITIALLY REPORTED THAT THE CUSTOMER EXPERIENCED A "PRESSURE-RELATED SURGE" WITH THE PHACO MACHINE WHICH CAUSED A POSTERIOR CAPSULAR TEAR RESULTING IN NOT ENOUGH STABILITY TO SUPPORT THE ONE-PIECE INTRAOCULAR LENS (IOL) AFTER INSERTED. HENCE, THE IOL WAS CUT OUT AND REMOVED FROM THE EYE. THE SURGEON THEN INSERTED A THREE-PIECE IOL BECAUSE THE SULCUS WAS STABLE, BUT THE TRAILING HAPTIC BROKE OFF. THIS THREE-PIECE IOL WAS ALSO CUT OUT AND REMOVED FROM THE EYE. THERE WAS INCISION ENLARGEMENT AND SUTURE REQUIRED. IN THE ABSENCE OF A BACK-UP LENS OF THE SAME STYLE AND POWER, THE PATIENT WAS LEFT APHAKIC WITHOUT A LENS IMPLANTED. NO FURTHER INFORMATION AVAILABLE. THIS MDR REPORT PERTAINS TO THE THREE-PIECE SUSPECT IOL. A SEPARATE REPORT HAS BEEN SUBMITTED UNDER THE PHACO UNIT REPORT NUMBER 3006695864-2020-00320 WHICH CAPTURES THE REPORTED CAPSULE TEAR, INCISION ENLARGEMENT, AND SUTURE.

  Patient problems: No Code Available

  MAUDE report 10279982 ↗