SENSAR IOL AR40e (REF AR40E00235)Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 05050474502178), received between Nov 9, 2017 and Sep 22, 2026 — classified as 10 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Break” (21 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 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50860829 ↗
• InjuryJul 27, 2026Material Fragmentation

  It was reported that two non-preloaded monofocal intraocular lenses (IOLs) were associated with complications during a surgical procedure involving the patient's right eye.The first lens (AR40C +23.5, SN (b)(6)) was the initial lens used. During implantation, a superior haptic was reported to be broken. The lens was not fully inserted into the patient's eye when the issue was identified.The second lens (AR40C +24.0, SN (b)(6)) was then implanted; however, disinsertion of the posterior haptic was observed. This lens was fully inserted into the patient's eye and subsequently removed.Additional information indicated that a capsular rupture occurred and that an unplanned anterior vitrectomy and incision enlargement were performed during the procedure. However, it is unknown at what point during the procedure the capsular rupture occurred or whether the vitrectomy and incision enlargement were associated with the first lens, the second lens, or another aspect of the procedure. No sutures were required. No replacement lens was implanted following removal of the lenses, and the patient remained aphakic. No cartridge tip damage or use error was reported. It was indicated that the device di

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Bag Tear; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50047507 ↗
• MalfunctionJun 1, 2026Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED BECAUSE THE TRAILING HAPTIC WAS BENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25356401 ↗
• MalfunctionFeb 11, 2026Material Fragmentation

  IT WAS REPORTED THAT THE HAPTIC BROKE OFF THE NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL). THE PROCEDURE WAS COMPLETED WITH A DIFFERENT LENS. THE EXTENT OF PATIENT CONTACT IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24311110 ↗
• MalfunctionJan 12, 2026Break; Material Fragmentation

  IT WAS REPORTED THAT DURING THE IMPLANTATION OF THE NON-PRELOADED INTRAOCULAR LENS (IOL), ONE OF THE HAPTICS WAS BENT AND PRESENTED DIFFICULTY IN OPENING AND SUBSEQUENTLY RUPTURED RESULTING IN AMPUTATION OF THE HAPTIC. THE IOL WAS IMPLANTED WITH ONLY ONE SUPPORT ROD, AND THE AMPUTATED ROD WAS REMOVED FROM THE PATIENT¿S EYE. THE PATIENT, A 65-YEAR-OLD MALE, HAS NOT EXPERIENCED ANY COMPLICATIONS TO DATE. THE IOL IS NOT AVAILABLE FOR ANALYSIS AS IT REMAINS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24032116 ↗
• MalfunctionOct 31, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23439289 ↗
• MalfunctionApr 25, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THREE PIECE MONOFOCAL INTRAOCULAR LENS (IOL) WAS INSERTED AND THEN REMOVED BECAUSE OF THE BREAKAGE OF A HAPTIC DURING INSERTION. THROUGH FOLLOW-UP, WE LEARNED THAT THE CUSTOMER HAS A SUSPICION THAT THE CARTRIDGES ARE FROM A FAULTY BATCH. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21915053 ↗
• MalfunctionMar 25, 2025Break; Break

  IT WAS REPORTED THAT A NON-PRELOADED LENS WAS WASTED DUE TO ONE HAPTIC CURLED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21690187 ↗
• MalfunctionMar 25, 2025Break; Break

  IT WAS REPORTED THAT A NON-PRELOADED LENS WAS WASTED DUE TO ONE HAPTIC CURLED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21690168 ↗
• MalfunctionMar 3, 2025Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS IMPLANTED BUT WAS REMOVED LATER DURING THE SAME PROCEDURE DUE TO A BROKEN HAPTIC. THROUGH FOLLOW-UP, WE LEARNED THAT NO BACKUP IOL WAS IMPLANTED. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21511203 ↗
• InjuryFeb 7, 2025Break; Break

  IT WAS REPORTED THAT THE NON-PRELOADED INTRAOCULAR LENS (IOL) PRESENTED A HAPTIC DAMAGED UPON LENS IMPLANTATION IN THE PATIENT'S RIGHT EYE. PRE-OPERATIVE VISUAL ACUITY WAS 30 CM. THE INSTRUCTIONS FOR USE WERE FOLLOWED. ACCOUNT INDICATED THAT THE LENS WAS PARTIALLY INSERTED IN THE PATIENT'S EYE. THE INCISION WAS ENLARGED, AND THE PATIENT UNDERWENT A VITRECTOMY. THE PATIENT HAS FULLY RECOVERED. THROUGH FOLLOW-UP, WE LEARNED THAT THE CARTRIDGE TIP WAS NOT DAMAGED AND THERE WAS NO RESISTANCE WHEN HANDLING THE CARTRIDGE. NO ADDITIONAL SURGICAL INTERVENTION IS PLANNED. NO FURTHER INFORMATION WAS PROVIDED. A SEPARATE REPORT (MFR REPORT 3012236936-2025-0000239) WILL BE SUBMITTED FOR THE CARTRIDGE MENTIONED ABOVE.

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

  MAUDE report 21339856 ↗
• MalfunctionJan 22, 2025Break; Break

  IT WAS REPORTED THAT THE ONE-PIECE INTRAOCULAR LENS (IOL) WAS DEFECTIVE. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21213754 ↗
• InjuryJun 6, 2024Break; Break

  IT WAS REPORTED THERE WAS A LENS REMOVAL DUE TO LENS DEFECT. THERE WAS NO DELAY IN TREATMENT OR OTHER INTERVENTIONS PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19480996 ↗
• InjuryMay 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT'S IMPLANT CARD WAS RECEIVED INDICATING THAT A MONOFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED. THE REASON FOR EXPLANT WAS NOT SPECIFIED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 19356176 ↗
• 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 19265409 ↗
• MalfunctionApr 23, 2024Break; Break

  IT WAS REPORTED THE LEADING HAPTIC OF AR40E MODEL INTRAOCULAR LENS (IOL) WAS BENT DURING FOLDING AND THERE WAS PATIENT CONTACT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19169193 ↗
• MalfunctionNov 29, 2023Break; Break

  IT WAS REPORTED THAT THE NON PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS REMOVED AND REPLACED FROM THE PATIENT'S RIGHT EYE DURING THE SAME PROCEDURE DUE TO HAPTICS BENT. THERE WAS NO INCISION ENLARGEMENT, SUTURES, OR VITRECTOMY NEEDED. NO INFORMATION IS PROVIDED ABOUT THE REPLACEMENT LENS. THE PATIENT'S POST-PROCEDURE STATUS IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18232099 ↗
• MalfunctionFeb 6, 2023Break; Break

  IT WAS REPORTED THAT DURING IMPLANTATION OF THE INTRAOCULAR LENS (IOL) INTO PATIENT'S OPERATIVE EYE, IT WAS IDENTIFIED THAT THE LENS WAS FAULTY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16308901 ↗
• MalfunctionMay 19, 2022Break; Difficult to Fold, Unfold or Collapse; Device Difficult to Setup or Prepare; Break; Difficult to Fold, Unfold or Collapse; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT THE AR40E WAS MARKED AS "COMPLAINT". THROUGH FOLLOW UP IT WAS LEARNED THAT THERE WAS AN ISSUE WITH THE HAPTIC. THE LENS CAME IN CONTACT WITH THE PATIENT'S EYE AND WAS DIFFICULT TO INSERT. IT WAS INDICATED THAT THE SURGERY WAS COMPLETED WITH A NEW LENS. MATERIAL HAS BEEN DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14444387 ↗
• MalfunctionMay 19, 2022Break; Difficult to Fold, Unfold or Collapse; Device Difficult to Setup or Prepare; Break; Difficult to Fold, Unfold or Collapse; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT THE AR40E WAS MARKED AS "COMPLAINT". THROUGH FOLLOW UP IT WAS LEARNED THAT THERE WAS AN ISSUE WITH THE HAPTIC. THE LENS CAME IN CONTACT WITH THE PATIENT'S EYE AND WAS DIFFICULT TO INSERT. IT WAS INDICATED THAT THE SURGERY WAS COMPLETED WITH A NEW LENS. MATERIAL HAS BEEN DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14442459 ↗
• MalfunctionApr 1, 2022Break; Break

  IT WAS REPORTED THE INTRAOCULAR LENS (IOL) WITH A DAMAGED HAPTIC. THERE WAS EYE CONTACT WITH THE CARTRIDGE. NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13972564 ↗
• InjuryJan 26, 2022Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING SURGERY AND PRIOR TO INTRAOCULAR LENS (IOL) IMPLANTATION, THE POSTERIOR CAPSULE RUPTURED. THE DOCTOR PROCEED TO IMPLANT THE INTRAOCULAR LENS IN THE CILIARY SULCUS. THE IOL POSITION WAS FOUND TO HAVE BEEN SHIFTED AFTER THE SURGERY. THEREFORE, THE PATIENT WAS GIVEN INTRAOCULAR LENS INTERNAL FIXATION. DURING THE SECONDARY SURGERY, IT AS FOUND THAT THE INTRAOCULAR LENS HAPTIC WAS TRANSFERRED OUT FROM THE CORNEAL INCISION. THE HAPTIC WAS FOUND TO BE BROKEN. THE CORNEAL INCISION WAS ENLARGED AND THE INTRAOCULAR LENS WAS COMPLETELY REMOVED. A REPLACEMENT LENS OF ANOTHER BRAND WAS USED. NO FURTHER INFORMATION AVAILABLE.

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

  MAUDE report 13354609 ↗
• InjuryJun 15, 2021Material Fragmentation; Material Fragmentation

  CUSTOMER REPORTED THAT DURING THE IMPLANT OF THE INTRAOCULAR LENS IN THE PATIENT'S LEFT EYE, IT WAS NOTICED THAT, AFTER THE IMPLANT OF THE OPTICAL PART AND LOWER HAPTIC, THE UPPER HAPTIC WAS NOT INSERTED IN THE OPTICAL PART. THE LENS WAS INTACT WHEN BEING PLACED IN THE CARTRIDGE AND IN THE INJECTOR. IT WAS LEARNED THAT THE LENS WAS INSERTED/REMOVED IN THE SAME PROCEDURE. INCISION WAS ENLARGED, VITRECTOMY WAS NEEDED, MEDICATION WAS PRESCRIBED, AND SUTURES WERE NEEDED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12005994 ↗
• InjuryApr 29, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THERE WAS CAPSULAR BAG RUPTURE FOLLOWED BY ANTERIOR VITRECTOMY. DOCTOR MENTIONED THAT THE LENS COULD NOT STAY IN PLACE IN SULCUS. ISSUE WAS OBSERVED AFTER IMPLANTATION. LENS WAS FULLY INSERTED AND REMOVED DURING SAME PROCEDURE. INCISION WAS ENLARGED, SUTURES WERE REQUIRED, AND THERE WAS DELAY IN PROCEDURE. NO OTHER INFORMATION PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 11749858 ↗
• MalfunctionApr 7, 2021Break; Break

  IT WAS REPORTED THAT DOCTOR BEFORE THE IMPLANTING OF THE INTRAOCULAR LENS (IOL) AND AFTER THE ADEQUATE MOUNTING, ACCORDING TO THE ROUTINE ORIENTED BY THE MANUFACTURER, IT WAS OBSERVED THAT THE SECOND HAPTIC OF THE IOL SUFFERED DEFORMATION CAUSED BY THE INJECTOR PISTON. THE IOL ISSUE WAS OBSERVED DURING HANDLING PRIOR TO INSERTION, NEVERTHELESS, WAS FULLY INSERTED. THE IMPLANT WAS IMMEDIATELY INTERRUPTED AND THE REPLACEMENT OF THE IOL AND CARTRIDGE WITH EQUIVALENT UNITS WERE REQUESTED AND IMPLANTED NORMALLY. NO OTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11631624 ↗