SENSAR IOL AR40e (REF AR40E00210)Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 05050474502123), received between Dec 30, 2016 and Sep 25, 2026 — classified as 21 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Break” (19 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 25 most recent of 47 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Material Fragmentation

  It was reported that a non-preloaded monofocal intraocular lens (IOL) was inserted into the patient's left eye and, during the implantation procedure, both haptics broke off inside the eye. The IOL was subsequently removed and replaced with another lens of the same model and diopter power. No unplanned vitrectomy or additional medical intervention outside the standard of care was reported. It is unknown whether unplanned sutures were required or whether the procedure was delayed. The patient outcome was unknown. It was noted that the lens was discarded. No further information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50892878 ↗
• MalfunctionJul 31, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50101228 ↗
• MalfunctionJul 29, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50075128 ↗
• MalfunctionJun 16, 2026Material Discolored

  IT WAS REPORTED THAT DURING CATARACT SURGERY, AFTER IMPLANTATION OF A THREE PIECE NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) IN THE RIGHT EYE, THE LENS BECAME MILKY WHITE INTRAOPERATIVELY. THE DOCTOR IMMEDIATELY REMOVED THE AFFECTED IOL AND REPLACED WITH A BACKUP IOL OF THE SAME MODEL, WHICH REMAINED CLEAR WITH NO SIGNS OF OPACIFICATION. THE EXPLANTED IOL REPORTEDLY RETURNED TO A CLEAR STATE AFTER REMOVAL. THERE WAS NO PATIENT INJURY WAS REPORTED. THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. THE PATIENT OUTCOME WAS REPORTED AS PLANNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25527487 ↗
• InjuryApr 17, 2026Device Difficult to Setup or Prepare; Use of Device Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE CONDUCTED ON (B)(6), 2026, THE FRONT HAPTIC OF THE ORIGINAL LENS WAS NOTED TO BE BENT DURING PREPARATION AND INSERTION, WHILE THE BACK HAPTIC HAD NOT YET ENTERED THE EYE. THE LENS WAS PARTIALLY DELIVERED AND SUBSEQUENTLY REMOVED FROM THE PATIENT'S EYE. A REPLACEMENT LENS OF THE SAME MODEL AND DIOPTER WAS LOADED AND INSERTED USING AN UNSPECIFIED CARTRIDGE. DURING THE IMPLANTATION OF THE REPLACEMENT LENS, A CAPSULE TEAR OCCURRED, REQUIRING AN ANTERIOR VITRECTOMY. TWO HOURS AFTER THE SURGERY, THE IMPLANT WAS OBSERVED TO BE DISLOCATED, AND THE PATIENT SHOWED SIGNS OF A POTENTIAL VITREOUS HEMORRHAGE. A FOLLOW-UP EXAMINATION ONE WEEK LATER REVEALED THE IMPLANT POSITIONED NEAR THE BOTTOM OF THE VITREOUS CAVITY, LEADING TO THE SCHEDULING OF A SECOND SURGERY WITH A RETINA PHYSICIAN ON (B)(6), 2026, TO RETRIEVE AND/OR REPLACE THE IMPLANT. THE SURGEON REPORTED ENCOUNTERING RESISTANCE AND NEEDING ADDITIONAL FORCE DURING THE INSERTION OF THE IMPLANTS, AS WELL AS EMPLOYING EXTRA SURGICAL MANEUVERS BEYOND STANDARD PRACTICE. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR THE REPLACEMENT LENS. THE ISSUE WITH THE ORIGINAL LENS DOES NOT MEET T

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

  MAUDE report 24918703 ↗
• InjuryApr 7, 2026Break; Mechanical Jam; Ejection Problem

  IT WAS REPORTED DURING IMPLANTATION OF AN INTRAOCULAR LENS, THE PLUNGER BECAME STUCK WITHIN THE CARTRIDGE, RESULTING IN THE TRAILING HAPTIC BEING KINKED. THE LENS WAS PARTIALLY INSERTED AND SUBSEQUENTLY REMOVED DURING THE SAME PROCEDURE. THE PATIENT EXPERIENCED TEMPORARY IMPAIRMENT. THE PATIENT PRE-OPERATIVE VISUAL ACUITY VALUE WAS 6/45 AND POST-OPERATIVE VISUAL ACUITY VALUE WAS 6/15. THERE WAS A DELAY OF A FEW MINUTES OCCURRED IN THE PROCEDURE. MEDICATION WAS PRESCRIBED TO THE PATIENT. THERE WERE NO OTHER INTERVENTIONS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24811519 ↗
• MalfunctionFeb 19, 2026Break

  IT WAS REPORTED THAT THE PATIENT DEMONSTRATED POOR COOPERATION, RESULTING IN FAILURE OF THE INITIAL IMPLANTATION ATTEMPT. THE INTRAOCULAR LENS WAS REMOVED AND RELOADED. DURING REINSERTION, THE ANTERIOR HAPTIC WAS DAMAGED DURING INJECTION. THEREFORE, THE INTRAOCULAR LENS WAS REPLACED WITH A NEW ONE. 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 24393638 ↗
• InjuryFeb 9, 2026Break

  IT WAS REPORTED THAT A THREE-PIECE, NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS NOTED TO HAVE ONE BROKEN HAPTIC AFTER IT WAS IMPLANTED IN THE PATIENT¿S EYE. IT WAS SUBSEQUENTLY REMOVED AND REPLACED WITH THE SAME MODEL BUT A DIFFERENT DIOPTER (AR40E, 21.5 D). ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE IOL WAS IMPLANTED IN THE PATIENT'S LEFT EYE BUT SUBSEQUENTLY REMOVED ON THE SAME PROCEDURE DUE TO THE CRIMPED HAPTIC AND WAS BROKEN UPON PLACEMENT. THE PUPIL MARGIN WAS ALSO DAMAGED UPON REMOVAL. VITRECTOMY WAS PERFORMED ALONG WITH THE LENS REPLACEMENT. SUTURES WERE USED TO EXTEND THE INCISION. IT WAS NOTED THAT THE USE OF SUTURE WAS NOT THE DOCTOR'S STANDARD PRACTICE. THE REMOVAL DID CAUSE EXTENSION OF THE INCISION AND THE NEED FOR THE SUTURE TO CLOSE. PATIENT INJURY WAS UNKNOWN BUT REPORTED AS "DOING WELL" AS PER DOCTOR. THE DEVICE IS NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24298708 ↗
• MalfunctionDec 18, 2025Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23845950 ↗
• MalfunctionAug 11, 2025Break; Failure to Fold; Ejection Problem; Break; Failure to Fold; Ejection Problem

  IT WAS REPORTED THAT PRIOR TO LOADING A MONOFOCAL INTRAOCULAR LENS (IOL) THE HAPTIC FOLDED IMPROPERLY IN THE PACKAGE. ALTHOUGH THE PHYSICIAN WAS ABLE TO LOAD THE LENS WITHOUT INCIDENT, THE HAPTIC BROKE DURING THE SURGEON'S ATTEMPT TO INSERT THE LENS INTO THE EYE. THROUGH FOLLOW UP, IT WAS LEARNED THAT THE LENS WAS PARTIALLY INSERTED IN THE PATIENT'S RIGHT EYE AND REMOVED IMMEDIATELY. ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND DIOPTER) WAS IMPLANTED AS A REPLACEMENT AND WITHOUT INCIDENT. THERE WERE NO MEDICAL/SURGICAL INTERVENTION OUTSIDE OF THE STANDARD CARE REQUIRED. THE PATIENT HAS FULLY RECOVERED. THE EXPLANTED LENS IS NOT AVAILABLE FOR INVESTIGATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22774717 ↗
• InjuryJul 20, 2025Break; Break

  IT WAS REPORTED BY THE CUSTOMER THAT AFTER A NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS IMPLANTED, THE HAPTIC WAS FOUND TO BE KINKED. THE LENS WAS FULLY INSERTED AND REMOVED DURING THE SAME PROCEDURE, REQUIRING SUTURES. THERE WAS A DELAY IN THE PROCEDURE, BUT NO VITRECTOMY WAS REPORTED. THE PATIENT'S DAILY ACTIVITIES WERE NOT SIGNIFICANTLY AFFECTED. THE CUSTOMER INDICATED THAT THE DIRECTIONS FOR USE WERE FOLLOWED, AND NO FURTHER PATIENT INFORMATION COULD BE PROVIDED DUE TO PRIVACY LEGISLATION. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 22552178 ↗
• MalfunctionMay 7, 2025Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) GOT TWISTED WHILE ADVANCING AND A HAPTIC TORE OFF. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21979388 ↗
• InjuryNov 18, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED, THAT NON-PRELOADED MONOFOCAL LENS WAS EXPLANTED FROM THE LEFT EYE AND LEFT APHAKIC. AS THE LENS WAS NOT STABLE IN THE SULCUS, AFTER IMPLANTATION. LENS WAS FULLY INSERTED AND REMOVED, DURING THE SAME PROCEDURE. PATIENT COULD PERFORM ONE OR MORE DAILY ACTIVITIES SHE PREVIOUSLY CONDUCTED. THERE IS REPORT OF UNPLANNED VITRECTOMY, INCISION ENLARGEMENT AND SUTURES. THERE IS DELAY IN TREATMENT FOR 1.5 HOURS. DIRECTIONS OF USE WERE FOLLOWED. NO OTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 20713191 ↗
• MalfunctionOct 25, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT A NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS PREPARED IN LENS CARTRIDGES. DURING PREPARATION, THE SURGEON ADVANCED THE IOL BEFORE INSERTING IT, CAUSING ONE OF THE HAPTICS TO BREAK INSIDE THE LENS CARTRIDGE. THERE WAS NO PATIENT CONTACT. ANOTHER LENS WAS PREPARED AND INSERTED INTO THE CARTRIDGE. THE LOADED CARTRIDGE WAS THEN PLACED INTO THE LENS INSERTER INSTRUMENT. AS THE SURGEON ADVANCED THE LENS INTO THE PATIENT'S EYE, HE REALIZED THAT ONE OF THE HAPTICS WAS MISSING. THE LENS WAS REMOVED FROM THE PATIENT'S EYE AND A NEW LENS WAS CHOSEN AND USED WITHOUT FURTHER ISSUES. THE PATIENT FULLY RECOVERED. THERE WERE NO UNPLANNED INCISIONS, SUTURES, OR VITRECTOMY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20536293 ↗
• InjurySep 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MONOFOCAL INTRAOCULAR LENS (IOL) WAS FULLY INSERTED INTO A PATIENT'S LEFT EYE AND REMOVED AS THE CAPSULE TORE AND THE DOCTOR HAD TO DO A VITRECTOMY AND USE SUTURE. A NON-JOHNSON AND JOHNSON LENS WAS INSERTED AS A REPLACEMENT. THE ISSUE WAS NOTED AFTER INSERTION OF THE LENS. THERE WAS NO INJURY REPORTED AND THE PATIENT IS DOING FINE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 20340294 ↗
• MalfunctionSep 27, 2024Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED THAT A MONOFOCAL INTRAOCULAR LENS (IOL) WAS WARPED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20318772 ↗
• MalfunctionSep 24, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT AFTER IMPLANTATION OF THE STANDALONE MONOFOCAL INTRAOCULAR LENS (IOL), THE SURGEON NOTED THE TRAILING HAPTIC HAD DETACHED. THROUGH FOLLOW UP WE LEARNED THAT THE IOL REMAINED IMPLANTED DUE TO SURGEONS PERCEPTION OF STABILITY OF THE IOL WITHIN THE EYE. ACCOUNT INDICATED THAT AN UNPLANNED VITRECTOMY WAS REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20297481 ↗
• MalfunctionSep 24, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT AFTER IMPLANTATION OF THE MONOFOCAL INTRAOCULAR LENS (IOL) THE SURGEON NOTED THE TRAILING HAPTIC HAD DETACHED. THROUGH FOLLOW UP WE LEARNED THAT THE IOL WAS REMOVED AND REPLACED IN THE SAME PROCEDURE, AND AN UNPLANNED VITRECTOMY WAS REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20297156 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LENS WAS INJECTED AND EXPLANTED. THERE WAS NO DELAY IN TREATMENT OR OTHER INTERVENTIONS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 20040303 ↗
• InjuryApr 11, 2024Break; Break

  IT WAS REPORTED THAT A NON PRE-LOADED SUSPECT LENS (IOL) WAS DAMAGED DURING IMPLANTATION, WITH PATIENT CONTACT, WITH VITRECTOMY PERFORMED. IT WAS STATED THAT BECAUSE THERE WAS PATIENT CONTACT, THE SUSPECT IOL WILL NOT BE RETURNED FOR EVALUATION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 19093436 ↗
• MalfunctionApr 11, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT A MONOFOCAL INTRAOCULAR LENS WAS FULLY INSERTED AND REMOVED IN THE SAME PROCEDURE DUE TO HAPTIC BROKE OFF. THE SURGEON BELIEVES IT WAS THE TRAILING HAPTIC; HOWEVER, SHE IS NOT SURE, AND SHE CUT IT IN HALF AND REMOVED IT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING NON-J&J IOL. THERE WAS NO INJURY, AND SURGICAL AND MEDICAL INTERVENTIONS WERE REQUIRED. THE PATIENT IS DOING WELL. THE PRODUCT IS BEING RETUNED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19091740 ↗
• MalfunctionDec 29, 2023Break; Ejection Problem; Break; Ejection Problem

  IT WAS REPORTED THE AR40E MODEL INTRAOCULAR LENS (IOL) HAPTIC WAS CROOKED BEFORE INSERTING INTO THE CARTRIDGE AND THE DOCTOR CHOOSE TO INSERT THE LENS. THE HAPTIC DOES NOT DEPLOY COMPLETELY INSIDE CAPSULAR BAG RESULTING IN THE IOL NOT BEING PROPERLY HELD. AN ATTEMPT IS MADE TO ACCOMMODATE THE LENS WITHOUT SUCCESS, IT WAS DECIDED TO REMOVE THE LENS AND REPLACE IT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18419815 ↗
• MalfunctionNov 3, 2023Break; Break

  IT WAS REPORTED THAT THE NON-PRELOADED INTRAOCULAR LENS (IOL) WAS DAMAGED. NO MEDICAL INTERVENTION WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18070034 ↗
• MalfunctionAug 31, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAPTIC WAS SEPARATED FROM THE OPTIC AND COULD NOT BE FIXED IN THE EYE. ISSUE WAS OBSERVED WHILE THE IOL WAS IMPLANTED INTO THE PATIENT'S OPERATIVE EYE. THE LENS WAS IMMEDIATELY REPLACED WITH A NEW IOL. THE SURGERY WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17667442 ↗
• InjuryMay 1, 2023Scratched Material; Scratched Material

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS FULLY INSERTED LENS, REMOVED AND REPLACED DUE TO LENS SCRATCHED. THERE WAS PATIENT CONTACT. SUSPECT PRODUCT WAS DISCARDED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16850395 ↗