SENSAR IOL AR40e (REF AR40E00215)Recalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 05050474502130), received between Apr 19, 2017 and Sep 22, 2026 — classified as 14 injuries, 43 malfunctions.

The most frequently reported specific device problem is “Break” (32 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 25 most recent of 57 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 2026Difficult to Insert

  It was reported that a three-piece non-preloaded monofocal intraocular lens (IOL) was opened on the back table and the haptics were observed to be bent/kinked prior to use. A backup IOL of the same model was used; however, it was implanted and subsequently removed due to positioning in the eye. The doctor then decided to perform a vitrectomy. The procedure was successfully completed using another IOL of the same model. An Emerald cartridge was used. No patient harm was reported. The ophthalmic viscosurgical device (OVD) and balanced salt solution (BSS) used were unknown. However, it was reported that the IOL was allowed to rest in the cartridge for a period of time before being handed to the doctor. No further information was provided.

  Patient problems: Eye Injury

  MAUDE report 50849614 ↗
• MalfunctionSep 17, 2026Break

  It was reported that the standalone Intraocular Lens (IOL) was defective and could not be implanted. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50805604 ↗
• MalfunctionJun 30, 2026Break

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING A THREE-PIECE MONOFOCAL NON-PRELOADED INTRAOCULAR LENS (IOL), RESISTANCE WAS ENCOUNTERED WHILE INSERTING THE CARTRIDGE, PREVENTING ADVANCEMENT OF THE LENS. PRIOR TO IMPLANTATION, WHEN ATTEMPTING TO REMOVE THE LENS FROM THE CARTRIDGE, THE OPTIC WAS OBSERVED TO BE KINKED AND THE HAPTIC WAS STUCK AT THE PLUNGER TIP AND HAD BROKEN. DESPITE THIS, THE LENS WAS IMPLANTED IN THE PATIENT¿S LEFT EYE. EXPLANTATION OF THE LENS WAS PLANNED BUT HAD NOT BEEN PERFORMED AT THE TIME OF REPORTING. POST-OPERATIVELY, THE PATIENT EXPERIENCED TEMPORARY VISUAL IMPAIRMENT, WITH BEST CORRECTED VISUAL ACUITY REPORTED AS 6/60, IMPROVING TO 6/18 (P4). THERE WERE NO REPORTS OF UNPLANNED INCISION ENLARGEMENT, UNPLANNED SUTURES, UNPLANNED VITRECTOMY, OR PROCEDURAL DELAY. NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION BEYOND STANDARD CARE WAS REQUIRED. THE SURGEON INDICATED THAT THE DIRECTIONS FOR USE WERE FOLLOWED AND CONFIRMED THAT THERE WAS NO PATIENT HARM. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25671286 ↗
• InjuryJun 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A THREE PIECE NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS IMPLANTED/EXPLANTED ON (B)(6) 2026. THE REASON OF IT WAS NOT SPECIFIED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 25429768 ↗
• InjuryJun 3, 2026Break

  IT WAS REPORTED THAT DURING IMPLANTATION OF THREE PIECE MONOFOCAL NON-PRELOADED INTRAOCULAR LENS (IOL) IN SULCUS, HAPTIC BROKE DURING MANIPULATION. HENCE LENS WAS REMOVED DURING SAME PROCEDURE. LENS WAS PARTIALLY INSERTED INTO PATIENT'S EYE. PATIENT WAS LEFT APHAKIC. A VITRECTOMY WAS PERFORMED AS PART OF THE INTERVENTION. THE PATIENT SUBSEQUENTLY EXPERIENCED SIGNIFICANT IMPACT ON DAILY ACTIVITIES, SOUGHT MEDICAL ATTENTION, AND WAS PRESCRIBED PREDNISOLONE. THE PROCEDURE DID NOT REQUIRE INCISION ENLARGEMENT OR SUTURES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25383061 ↗
• MalfunctionMay 13, 2026Scratched Material

  IT WAS REPORTED THAT A NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS SCRATCHED DURING DEPLOYMENT. THE EXTENT OF PATIENT CONTACT IS UNKNOWN. THE LENS WAS DISCARDED AND IS NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25164753 ↗
• InjuryJan 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO CHANGE IN THE PATIENT¿S CONDITION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 24227964 ↗
• MalfunctionJan 29, 2026Break; Failure to Fold

  IT WAS REPORTED THAT THE STANDALONE INTRAOCULAR LENS (IOL) HAD ISSUES WITH BROKEN HAPTIC AND LENS NOT FOLDING PROPERLY. THE IOL IS NOT AVAILABLE FOR EVALUATION AS THE CUSTOMER DID NOT RETAIN THE LENS. THERE WAS NO PATIENT OR USER HARM REPORTED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24214727 ↗
• MalfunctionNov 21, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE LEADING HAPTIC ON THE NON-PRELOADED INTRAOCULAR LENS (IOL) BROKE OFF WHILE INSERTING INTO THE PATIENT'S EYE. THROUGH FOLLOW UP, WE LEARNED THAT POST IMPLANTATION OF THE IOL, DURING MANIPULATION, THE HAPTIC WAS BROKEN. THE IOL WAS THEN REMOVED AND REPLACED WITH A BACKUP DEVICE TO PREVENT INJURY TO THE PATIENT. THE DEVICE WAS DISCARDED DURING THE PROCEDURE THUS, IS NOT AVAILABLE FOR PRODUCT INVESTIGATION. THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23622285 ↗
• InjuryOct 31, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT WHILE ATTEMPTING TO IMPLANT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) IN THE LEFT EYE THE FOLLOWING OCCURRED. THE PROCEDURE HAD STARTED WHEN IT WAS OBSERVED THAT THE POSTERIOR CAPSULE RUPTURED. THE HAPTIC OF THE IOL MOVED POSTERIORLY. THE DOCTOR USED A SKINSKEY AND HOOK TO MANIPULATE THE ANTERIOR HAPTIC BUT IT BECAME DETACHED FROM THE LENS. THE PATIENT WAS LEFT APHAKIC AND AN ANTERIOR VITRECTOMY WAS PERFORMED. THE IOL PLACEMENT WAS DEFERRED FOR A LATER TIME. NO USE ERROR WAS REPORTED. REPORTEDLY, THE DEVICE IS AVAILABLE FOR RETURN.

  Patient problems: Capsular Bag Tear

  MAUDE report 23441904 ↗
• MalfunctionOct 21, 2025Break; Break

  IT WAS REPORTED THAT DURING A CATARACT SURGERY A CAPSULE RUPTURE OCCURRED REQUIRING AN ANTERIOR VITRECTOMY. A SENSAR 3-PIECE INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE. DESPITE BEING CORRECTLY ASSEMBLED IN THE CARTRIDGE, THE HAPTIC OF THE LENS WAS FOUND TO BE BROKEN. THE LENS WAS REPLACED DURING THE SAME SURGICAL PROCEDURE WITH ANOTHER LENS OF IDENTICAL CHARACTERISTICS. THE PATIENT WAS REPORTED TO BE IN GOOD POSTOPERATIVE CONDITION, AND NO ADDITIONAL MEDICATION BEYOND THE STANDARD OF CARE WAS ADMINISTERED. NO FURTHER MEDICAL OR SURGICAL INTERVENTIONS WERE PLANNED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23348496 ↗
• MalfunctionAug 27, 2025Break; Break

  IT WAS REPORTED BY A CUSTOMER THAT THE LENS HAD BROKEN HAPTICS. REPORTEDLY CUSTOMERS DISCARDED THE LENS. THERE WAS NO PATIENT HARM OR ADVERSE EVENTS ASSOCIATED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22909040 ↗
• MalfunctionMay 22, 2025Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED THAT A NON-PRELOADED LENS HAD A BENT HAPTIC AND THEY COULD NOT GET IT INSERTED INTO THE EYE. THERE WAS PATIENT CONTACT WITH IOL. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22075102 ↗
• MalfunctionApr 29, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE COMPLAINT REPORTED AGAINST THE AR40E MODEL INTRAOCULAR LENS (IOL) WAS "CONPLAINS 69 MILITARY." NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21931824 ↗
• MalfunctionMar 24, 2025Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) FAILED DURING PLACEMENT DUE TO THE DISTAL HAPTIC BEING DE-CRIMPED DURING THE INJECTION. ADDITIONAL FOLLOW UP WITH THE ACCOUNT REVEALED THAT THERE WAS PATIENT CONTACT WITH THE DEVICE. NO FURTHER DETAIL WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21684147 ↗
• MalfunctionNov 19, 2024Material Fragmentation; Ejection Problem; Material Fragmentation; Ejection Problem

  IT WAS REPORTED THAT THE CARTRIDGE OF THE PRELOADED INTRAOCULAR LENS (IOL) WAS INSERTED AND THE LENS WAS ADVANCED FORWARD. THE LENS GOT JAMMED IN THE CARTRIDGE TIP AND WAS PULLED OUT. THE HAPTIC ONLY WAS INSERTED. THE LENS WAS PARTIALLY INSERTED AND THE ISSUE WAS NOTICED DURING IMPLANTATION AND APPLICATION. THE LENS WAS INSERTED AND REMOVED DURING THE SAME PROCEDURE. THE PATIENT HAD FULLY RECOVERED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20719406 ↗
• MalfunctionAug 22, 2024Break; Break

  IT WAS REPORTED THAT THE LENS WAS BROKEN WHEN INSERTED INTO THE CARTRIDGE. THE LENS WAS REMOVED. THERE WAS REPLACEMENT LENS. THERE WAS NO DELAY IN TREATMENT OR OTHER INTERVENTIONS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20041677 ↗
• MalfunctionAug 13, 2024Break; Break

  IT WAS REPORTED THAT A MONOFOCAL 3 PC. INTRAOCULAR LENS (IOL), HAD THE HAPTIC CAME OUT OF THE INJECTOR KINKED SO IOL COULD NOT BE USED. IT WAS NOTED THAT THE LENS WAS IMPLANTED AND THEN EXPLANTED. THE HAPTIC TOUCHED THE PATIENT'S LEFT EYE. IT WAS CLARIFIED BY THE DOCTOR THAT EVENT COULD BE DUE TO PATIENT ANATOMY ISSUE. IT WAS A DIFFICULT CATARACT. THE UNPLANNED VITRECTOMY WAS ALREADY DONE BEFORE THE LENS TOUCHED THE EYE. LENS/INJECTOR DID NOT CAUSE THE NEED FOR VITRECTOMY. THERE WAS NO CAPSULE TEAR. HOWEVER, THERE WAS LACK OF ZONULE SUPPORT. CARTRIDGE MODEL WOULD HAVE BEEN THE EMERALD CARTRIDGE. INCISION ENLARGEMENT AND SUTURES WERE PERFORMED. DOCTOR STATED THAT AS A PRECAUTION TO HELP PREVENT OTHER POTENTIAL ISSUES. 2 CORNEA SUTURES WERE PLACED. THE SURGERY WAS SUCCESSFULLY COMPLETED USING THE SAME MODEL 22.0 DIOPTER POWER SIZE BACK-UP LENS. THE PATIENT HAD VOMITING ON AND OFF FOR 24 HOURS AND PAIN, WHICH WAS ALLEVIATED WITH TYLENOL 500MG. NO OTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 19977750 ↗
• MalfunctionMay 23, 2024Break; Break

  IT WAS REPORTED THAT THERE WAS A FAULTY NON PRELOADED INTRAOCULAR LENS AS HAPTIC BROKE IN INJECTOR. ISSUE WAS NOTICED DURING IMPLANTATION. LENS WAS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19388190 ↗
• MalfunctionMay 10, 2024Break; Break

  IT WAS REPORTED THAT THERE WAS HAPTIC BENT DURING IMPLANTATION OF THE INTRAOCULAR LENS (IOL). THERE WAS NO DELAY IN TREATMENT OR OTHER INTERVENTIONS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19288771 ↗
• 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 19265280 ↗
• 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 19265248 ↗
• 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 19264077 ↗
• MalfunctionApr 9, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE HAPTIC OF THE NON PRELOADED INTRAOCULAR LENS (IOL) BROKE OFF AFTER THE LENS WAS INSERTED. THE ISSUE WAS IDENTIFIED AFTER INSERTING INTO THE EYE. THERE WAS NO PATIENT INJURY. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19075461 ↗
• MalfunctionDec 21, 2023Break; Break

  IT WAS REPORTED THAT, DURING THE PATIENT'S CATARACT SURGERY, ONE SIDE OF THE INTRAOCULAR LENS BROKE WHEN USING AN INTRAOCULAR LENS INJECTOR TO IMPLANT THE NON-PRELOADED INTRAOCULAR LENS (IOL). REMOVED THE DAMAGED INTRAOCULAR LENS THROUGH A LARGE INCISION AND REPLACED THE INTRAOCULAR LENS IMPLANT. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 18378452 ↗