SENSAR IOL AR40e (REF AR40E00240)Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 05050474502185), received between Oct 7, 2016 and Jul 27, 2026 — classified as 5 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Break” (16 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Break

  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 50047582 ↗
• MalfunctionMay 29, 2026Break; Difficult to Fold, Unfold or Collapse; Use of Device Problem; Mechanical Jam

  THE ACCOUNT REPORTED A DEPLOYMENT ISSUE WITH A NON-PRELOADED MONOFOCAL INTRAOCULAR LENS DURING A SURGICAL PROCEDURE. THE LENS EXHIBITED A CROOKED TRAILING HAPTIC THAT FAILED TO OPEN AS EXPECTED, PREVENTING PROPER ADVANCEMENT AND REMAINED CROOKED WITHIN THE EYE. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 25338130 ↗
• InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO NON-PRELOADED MONOFOCAL INTRAOCULAR LENSES (IOLS) WERE ATTEMPTED BUT NOT IMPLANTED IN THE PATIENT¿S LEFT EYE (OS), RESULTING IN THE PATIENT LEAVING SURGERY APHAKIC. INITIALLY, AN ATTEMPT WAS MADE TO IMPLANT A ZCB00 MODEL LENS IN THE SULCUS OF THE LEFT EYE AND THE LENS WAS FULLY INSERTED; HOWEVER, THE IOL WAS UNSTABLE IN SULCUS AND THE ZONULES WERE NOTED TO BE UNSTABLE/LOOSE. AS A RESULT, THE LENS WAS REMOVED AND AN UNPLANNED ANTERIOR VITRECTOMY WAS PERFORMED. THE PRE-OPERATIVE BEST SPECTACLE-CORRECTED VISUAL ACUITY (BSCVA) WAS REPORTED AS 20/25-3. SUBSEQUENTLY, AN ATTEMPT WAS MADE TO IMPLANT AN AR40E LENS AS AN ANTERIOR CHAMBER IOL (ACIOL) IN THE LEFT EYE. DURING THIS ATTEMPT, PATIENT MOVEMENT OCCURRED AND AN IRIS DIALYSIS WITH SPHINCTER TEAR WAS REPORTED. THE IOL WAS REMOVED, AND NO ADDITIONAL INTERVENTIONS WERE PERFORMED. NO REPLACEMENT IOL WAS IMPLANTED, AND THE PATIENT WAS SENT HOME APHAKIC. ALTHOUGH SUTURES WERE INITIALLY INDICATED, FOLLOW-UP WITH THE ACCOUNT CONFIRMED THAT NO ADDITIONAL INTERVENTIONS WERE REQUIRED. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT PERTAINS TO THE LENS MODEL AR40E. A SEPARATE REPORT WILL BE SUBMITTED FOR THE LENS, MODEL

  Patient problems: Eye Injury

  MAUDE report 24948519 ↗
• InjuryMar 4, 2026Material Fragmentation

  IT WAS REPORTED THAT THE HAPTIC BECAME DETACHED FROM THE LENS OPTIC AFTER IMPLANTATION INTO THE PATIENT¿S EYE. AN EXPLANT WAS PERFORMED IN SECONDARY SURGICAL PROCEDURE, AND THE LENS WAS REPLACED. THERE WAS NO DELAY IN TREATMENT, AND NO ADDITIONAL INTERVENTIONS WERE REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24508600 ↗
• MalfunctionFeb 19, 2026Break

  IT WAS REPORTED THAT HAPTIC BROKE AFTER INSERTING INTRAOCULAR LENS (IOL) INTO THE EYE. IOL WAS REMOVED AND REPLACED. INCISION ENLARGED AND SUTURES WERE REQUIRED. NO FURTHER INFORMATION AVAILABLE.

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

  MAUDE report 24393736 ↗
• MalfunctionDec 3, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) TRAILING HAPTIC WAS AMPUTATED UPON INSERTION. THERE WAS PATIENT CONTACT, HOWEVER, THE EXTENT OF PATIENT CONTACT IS UNKNOWN. THE PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23708376 ↗
• MalfunctionJul 16, 2025Break; Break

  IT WAS REPORTED THAT THE HAPTIC OF THE INTRAOCULAR LENS (IOL) WAS DEFECTIVE. THROUGH FOLLOW-UP, WE LEARNED THAT THE LENS WAS REMOVED FROM THE EYE DURING IMPLANTATION AFTER A TEAR OCCURRED IN THE RHEXIS. THE IOL WAS DISCARDED. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: Capsular Bag Tear

  MAUDE report 22527431 ↗
• MalfunctionJul 8, 2025Break; Difficult to Insert; Break; Difficult to Insert

  IT WAS REPORTED THAT THE LENS OF A NON PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) FELL TO BACK OF THE EYE AFTER BEING PLACED. A DIFFERENT LENS WAS NEEDED AND USED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22447543 ↗
• MalfunctionMay 22, 2025Break; Break

  IT WAS REPORTED THAT THE STANDALONE 3 PIECE MONOFOCAL INTRAOCULAR LENS (IOL) WAS BROKEN. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22075198 ↗
• MalfunctionMay 19, 2025Break; Break

  IT WAS REPORTED THAT THE MATERIAL, 3-PIECE INTRAOCULAR LENS (IOL), WAS DEFECTIVE. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22048821 ↗
• 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 19265229 ↗
• MalfunctionJun 12, 2023Break; Failure to Fold; Break; Failure to Fold

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) LEADING HAPTIC COULD NOT OPEN AND THE LENS HAPTIC BROKE AFTER IMPLANTING THE IOL IN THE PATIENT'S EYE. THE WOUND HAD TO BE EXTENDED TO REMOVE THE IOL. THERE WAS SUTURES PERFORMED AND MEDICATIONS PRESCRIBED. THE PATIENT WAS TEMPORARILY IMPAIRED AND HIS DAILY ACTIVITIES WERE SIGNIFICANTLY AFFECTED. PATIENT IS CURRENTLY APHAKIC. THERE WAS NO DELAY IN TREATMENT OR OTHER INTERVENTIONS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 17114505 ↗
• MalfunctionApr 10, 2023Break; Break

  IT WAS REPORTED THAT ONE HAPTIC OF THE INTRAOCULAR LENS (IOL), DESCRIBED BY THE CUSTOMER AS THE DISTAL LOOP, WAS BROKEN DURING PLUNGER ADVANCEMENT. NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16710652 ↗
• MalfunctionMar 6, 2023Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS DEFECTIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16492496 ↗
• MalfunctionOct 4, 2022Break; Break

  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 15541346 ↗
• MalfunctionMay 11, 2021Break; Break

  IT WAS REPORTED THAT DURING AN OPERATION, THE SURGEON INSERTED AN INTRAOCULAR LENS (IOL) WITH AN EMERALD CARTRIDGE AND A CRACK IN THE OPTIC WAS OBSERVED WHEN THE IOL WAS IMPLANTED. THE LENS WAS REMOVED BY CUTTING IT WITH AN IOL CUTTER. A NON-JOHNSON AND JOHNSON LENS WAS IMPLANTED AS A REPLACEMENT. IT WAS INDICATED THAT WHEN THE DOCTOR USED THE IOL CUTTER, THE AREA AROUND THE INCISION WAS DAMAGED; HOWEVER, NO SUTURE AND INCISION ENLARGEMENT WAS REPORTED. THE ACCOUNT INDICATED THAT THERE MAY HAVE BEEN A PROBLEM WITH THE SETTING/LOADING OF THE LENS IN THE CARTRIDGE. THERE WAS NO HEALTH HAZARD AND NO INJURY TO THE PATIENT REPORTED. IT WAS NOTED THAT THE LENS WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11804188 ↗
• MalfunctionMay 11, 2021Inaccurate Delivery; Scratched Material; Inaccurate Delivery; Scratched Material

  IT WAS REPORTED THAT DURING OPERATION, THE SURGEON INSERTED AN INTRAOCULAR LENS (IOL) WITH AN EMERALD CARTRIDGE. THE LENS WAS CUT AND REMOVED BECAUSE THE IOL WAS INSERTED IN THE REVERSE POSITION. WHEN THE LENS WAS IN THE EYE, ALSO COSMETIC ISSUE ON THE OPTICAL PART OF THE LENS WAS NOTICED. THE DOCTOR INDICATED THAT THERE MAY HAVE BEEN A PROBLEM WITH THE SETTING/LOADING OF THE LENS IN THE CARTRIDGE. A NON-JOHNSON AND JOHNSON LENS WAS USED A THE REPLACEMENT. REPORTEDLY WHEN THE DOCTOR USED THE IOL CUTTER TO CUT THE LENS, THE AREA AROUND THE INCISION WHERE THE LENS WAS INSERTED WAS DAMAGED; HOWEVER, NO SUTURE OR INCISION ENLARGEMENT WAS REPORTED. THERE WAS NO HEALTH HAZARD WITH THE PATIENT REPORTED. IT WAS NOTED THAT THE LENS WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11804173 ↗
• InjuryMar 24, 2021Break; Difficult to Fold, Unfold or Collapse; Break; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD UNFOLDING ISSUE (HAPTIC BROKE INSIDE). ADDITIONAL INFORMATION RECEIVED STATES THE LENS WAS DELIVERED INTO THE PATIENT'S LEFT EYE, THE HAPTIC WAS MANGLED, AND IT TORE THROUGH THE BAG AND BROKE. AN ANTERIOR VITRECTOMY WAS THEN PERFORMED. THERE WAS PATIENT CONTACT AS REMOVAL AND REPLACEMENT HAPPENED DURING THE SAME PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A BACKUP LENS OF THE SAME MODEL AND DIOPTER. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 11559091 ↗
• MalfunctionMar 12, 2021Break; Break

  IT HAS BEEN REPORTED ISSUES WITH AN AR40E INTRAOCULAR LENS (IOL). DEFECTIVE LENS, HAPTIC WAS TWISTED. NO PATIENT INJURY HAS BEEN REPORTED, AND IT IS UNKNOWN IF THERE WAS ANY PATIENT'S CONTACT. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11468465 ↗
• InjuryApr 8, 2019Break; Human-Device Interface Problem; Break; Human-Device Interface Problem

  IT WAS INITIALLY REPORTED THAT THE HAPTIC OF THE IOL (INTRAOCULAR LENS) WAS WEDGED-IN DURING THE LOADING PROCESS AND WAS OBSERVED KINKED/BENT WHEN INSERTED INTO THE PATIENT'S EYE. REPORTEDLY, THE LENS WAS REMOVED AND A NEW LENS WAS IMPLANTED WITHOUT ISSUES DURING THE INITIAL PROCEDURE. THROUGH FOLLOW UP IT WAS LEARNED THAT THE INCISION WAS MINIMALLY ENLARGED TO ALLOW THE REMOVAL OF THE LENS BUT DID NOT REQUIRE SUTURES OR VITRECTOMY. THE PATIENT AND THE SURGEON WERE REPORTED BEING HAPPY WITH THE OUTCOME. THE ACCOUNT COMMENTED THAT THE LENS WAS DESTROYED AT THE CUSTOMER SITE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8491161 ↗
• MalfunctionOct 27, 2017Material Too Rigid or Stiff; Torn Material; Material Too Rigid or Stiff; Torn Material

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS INSERTED AND REMOVED FROM THE EYE OF A (B)(6) FEMALE PATIENT, BECAUSE THERE WAS A FISSURE IN THE MIDDLE OF THE OPTIC ZONE. IT WAS ALSO REPORTED THAT LENS WAS TOO RIGID. REPORTEDLY, THERE WAS A DELAY OF 40 MINUTES IN THE PROCEDURE. NO SECONDARY MEDICAL INTERVENTION WAS REQUIRED. AT A LATER DATE, FURTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THAT THE LENS WAS BROKEN (NO DETAIL PROVIDED), THE LENS WAS NOT IMPLANTED AND NEW LENS, SAME MODEL AND DIOPTER WAS IMPLANTED. THERE WAS NO PATIENT INJURY AND THE PATIENT OUTCOME IS STABLE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6985481 ↗
• MalfunctionOct 7, 2016Scratched Material; Scratched Material

  AFTER IMPLANTATION OF THE INTRAOCULAR LENS (IOL), THE CUSTOMER NOTICED THAT THE INJECTOR MARKED THE LENS. THE IOL HAD TO BE CUT AND REMOVED FROM THE EYE. ANOTHER LENS WAS IMPLANTED. NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6012511 ↗