SENSAR IOL AR40e (REF AR40E00220)Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 05050474502147), received between Oct 4, 2016 and Jun 4, 2026 — classified as 22 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Break” (20 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 45 reports, in the reporter's own words as published by the FDA.

• InjuryJun 4, 2026Break

  IT WAS REPORTED THAT A NON-PRELOADED THREE-PIECE INTRAOCULAR LENS (IOL) WAS LOADED INTO A BUTTERFLY INJECTOR. HIGH PRESSURE WAS NOTED DURING DELIVERY, AND THE TRAILING HAPTIC KINKED. A POSTERIOR CAPSULE RENT OCCURRED, AND THE LENS WAS SUBSEQUENTLY EXPLANTED. A VITRECTOMY WAS PERFORMED, AND MEDICATIONS WERE PRESCRIBED FOR THE POSTERIOR CAPSULE RENT COMPLICATIONS. THE PROCEDURE WAS DELAYED BY 30 MINUTES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 25398577 ↗
• MalfunctionMay 6, 2026Material Fragmentation

  IT WAS REPORTED THAT WHEN THE NON-PRELOADED INTRAOCULAR LENS (IOL) WAS IMPLANTED, THE HAPTIC WAS TORN OFF INTO THE PATIENT'S OPERATIVE EYE. THE IOL WAS REMOVED FROM THE EYE AND A REPLACEMENT LENS WAS IMPLANTED TO COMPLETE THE SURGERY. AN EMERALD UNFOLDER WAS USED TO DELIVER AND IMPLANT THE IOL AND IT WAS HANDLED AS USUAL, WITHOUT ANY PROBLEMS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25107440 ↗
• MalfunctionApr 21, 2026Break

  IT WAS REPORTED THAT DURING IMPLANTATION OF THE NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), MODEL AR40E, THE LENS WAS SUSPECTED TO HAVE BROKEN DURING INJECTION. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT THE LENS BROKE DURING AN ATTEMPTED INSERTION. TO THE BEST OF THE REPORTER¿S KNOWLEDGE, THERE WAS NO PATIENT INJURY, AND ANOTHER LENS OF THE SAME TYPE WAS SUCCESSFULLY IMPLANTED. THE AFFECTED LENS REQUIRED MANUAL LOADING. IT REMAINS UNCLEAR WHETHER THE EVENT WAS DUE TO USER ERROR OR A POTENTIAL PRODUCT DEFECT. THE REPORTER DECLINED TO PROVIDE PATIENT IDENTIFICATION INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24946880 ↗
• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS REMOVED FROM THE RIGHT EYE BECAUSE THE PATIENT¿S CAPSULAR SUPPORT WAS INSUFFICIENT TO HOLD THE LENS. THE LENS WAS FULLY INSERTED AND REMOVED DURING THE SAME PROCEDURE, WITH NO REPLACEMENT IMPLANTED. IT IS UNKNOWN WHETHER THE PATIENT SUSTAINED ANY INJURY OR WHETHER ANY MEDICATION OUTSIDE THE STANDARD OF CARE WAS PRESCRIBED. IT IS ALSO UNKNOWN WHETHER ANY UNPLANNED SURGICAL INTERVENTIONS, SUCH AS VITRECTOMY, INCISION ENLARGEMENT, OR SUTURING, WERE PERFORMED. THE PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 24747844 ↗
• MalfunctionMar 25, 2026Difficult to Insert

  IT WAS REPORTED THAT A CAPSULAR BAG INTRAOCULAR LENS (IOL) IMPLANTATION WAS PLANNED FOR THE PATIENT; HOWEVER, A CAPSULAR BAG RUPTURE OCCURRED DURING SURGERY. AS A RESULT, THE SURGEON ELECTED TO IMPLANT A 3-PIECE IOL. MULTIPLE ATTEMPTS WERE MADE TO POSITION THE LENS, BUT PROPER PLACEMENT COULD NOT BE ACHIEVED, LEADING TO ITS EXPLANTATION. DURING REMOVAL, THE IOL UNDERWENT SEVERAL SHAPE CHANGES AND WAS DISCARDED. THE PROCEDURE WAS THEN COMPLETED WITH THE IMPLANTATION OF AN ANTERIOR CHAMBER IOL FROM ANOTHER MANUFACTURER. NO ADDITIONAL TREATMENT WAS REQUIRED. IT WAS ALSO CLARIFIED THAT THE CAPSULAR RUPTURE WAS UNRELATED TO ANY JOHNSON & JOHNSON PRODUCT AND WAS ATTRIBUTED TO THE PATIENT¿S OCULAR CONDITION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24692974 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  DURING A PROCEDURE INVOLVING THE AR40E MODEL INTRAOCULAR LENS (IOL) A PARS PLANA VITRECTOMY WAS PERFORMED. BOTH EXTENT OF PATIENT CONTACT WITH THE LENS AND PATIENT PROGNOSIS POST-PROCEDURE ARE UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24063309 ↗
• InjuryJul 28, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE NON-PRELOADED SENSAR MONOFOCAL INTRAOCULAR LENS (IOL) WAS INITIALLY STUCK IN THE CARTRIDGE BUT WAS IMPLANTED. THE PREOPERATIVE BEST CORRECTED VISUAL ACUITY WAS 6/24, WHILE THE POSTOPERATIVE BEST CORRECTED VISUAL ACUITY IMPROVED TO 6/7.5. THERE WERE REPORTS OF REQUIRED INCISION ENLARGEMENT, UNPLANNED VITRECTOMY, UNPLANNED SUTURES, ALONG WITH A DELAY IN THE PROCEDURE. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Eye Injury; Visual Impairment

  MAUDE report 22628090 ↗
• InjuryJul 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE STANDALONE 3 PIECE MONOFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: Capsular Bag Tear; Eye Injury

  MAUDE report 22523760 ↗
• InjuryJul 1, 2025Break; Break

  IT WAS REPORTED THAT THE NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) HAPTIC WAS BROKEN UPON MANIPULATING THE LENS AFTER IMPLANTATION ON (B)(6) 2025. THE LENS WAS FULLY INSERTED INTO THE PATIENT'S EYE BUT WAS SUBSEQUENTLY REMOVED DURING THE SAME PROCEDURE. THE PATIENT'S STATUS WAS TEMPORARILY IMPAIRED. THE PRE-OPERATIVE VISION WAS (B)(6). VIGAMOX WAS PRESCRIBED AS PART OF THE STANDARD THERAPY FOLLOWING THE EVENT. ON (B)(6) 2025, ADDITIONAL INFORMATION CONFIRMED THAT SUTURES WERE REQUIRED DUE TO INCISION ENLARGEMENT, AND A VITRECTOMY WAS PERFORMED AS A COMPLICATION ASSOCIATED WITH THE DEVICE. THE DELAY IN THE PROCEDURE WAS CONSIDERED CLINICALLY SIGNIFICANT. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 22379066 ↗
• MalfunctionJun 13, 2025Break; Break

  IT WAS REPORTED THAT THE NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) BROKE DURING USE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22205019 ↗
• InjuryMay 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CASE INVOLVING THE AR40E MODEL INTRAOCULAR LENS (IOL) TURNED INTO A COMPLICATED ANTERIOR VITRECTOMY DUE TO THE PATIENT'S ANATOMY. THE DOCTOR HAD TO USE FOUR (04) LENSES AND THREE (03) WERE DESTROYED IN THE SURGICAL PROCESS. THE SURGERY WAS COMPLETED DURING THE SAME PROCEDURE. PATIENT PROGNOSIS POST PROCEDURE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 22111059 ↗
• MalfunctionFeb 9, 2025Material Fragmentation; Ejection Problem; Material Fragmentation; Ejection Problem

  IT WAS REPORTED THAT THE MONOFOCAL INTRAOCULAR LENS (IOL) WAS PARTIALLY INSERTED INTO A PATIENT'S RIGHT EYE & REMOVED IN THE SAME PROCEDURE AS THE TRAILING HAPTIC SNAPPED-OFF DURING INSERTION. THE PROCEDURE WAS COMPLETED USING ANOTHER LENS OF THE SAME MODEL AND DIOPTER (22.0D). THERE WAS PATIENT CONTACT WITH CARTRIDGE AND LENS. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT OUTCOME STATUS WAS REPORTED AS NO ISSUES/PROBLEMS. NO FURTHER INFORMATION WAS PROVIDED. THE PATIENT HAD BILATERAL LENS IMPLANTATION. THIS REPORT PERTAINS TO THE PATIENT'S RIGHT EYE. A SEPARATE REPORT IS BEING SUBMITTED FOR THE PATIENT'S LEFT EYE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21341135 ↗
• InjuryJan 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED A VITRECTOMY WHILE USING A SENSAR 3-PIECE ACRYLIC MONOFOCAL INTRAOCULAR LENS (IOL) ON PATIENT'S LEFT EYE (OS) OCULUS SINISTER. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 21069116 ↗
• MalfunctionNov 13, 2024Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20675549 ↗
• MalfunctionSep 20, 2024Break; Break

  IT WAS REPORTED THAT THE HAPTIC WAS DAMAGED ON A MONOFOCAL INTRAOCULAR LENS (IOL). ALTHOUGH THE REPORT INDICATED THAT WHEN OPENED THE INTRAOCULAR LENS (IOL), THE HAPTIC WAS NOTED TO BE BROKEN, THAT THERE WAS NO PATIENT CONTACT; HOWEVER, THE REPORT ALSO INDICATED THAT THE PATIENT WAS OUTCOME STATUS AS TEMPORARILY IMPAIRED AND UNKNOWN. ALSO DELAY IN PROCEDURE MENTIONED. IT WAS NOTED THAT IT IS UNKNOWN IF PATIENT'S DAILY ACTIVITIES WERE AFFECTED. NO SUTURES OR VITRECTOMY REQUIRED. NO MEDICATION WAS PRESCRIBED. ADDITIONAL INFORMATION CONFIRMED THAT THERE WAS NO HARM TO THE PATIENT AS THE IOL WAS REPLACED/ANOTHER LENS WAS USED FOR THE LEFT EYE OF THE PATIENT AT THE TIME OF THE PROCEDURE AND THAT THE DELAY WAS NOT RELATED TO THE DEVICE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20274466 ↗
• MalfunctionJul 25, 2024Break; 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 19833959 ↗
• MalfunctionJul 25, 2024Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19833952 ↗
• InjuryJul 8, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT IS REPORTED THAT THE MONOFOCAL INTRAOCULAR LENS(IOL) WAS EXPLANTED BECAUSE IT WAS SLIGHTLY DISLOCATED, CAUSING A DISRUPTION IN ACUITY. REPLACED WITH AR40E 19.0. UNKNOW IF INJURY OR MEDICAL INTERVENTION IS REQUIRED. THE PATIENT'S STATUS IS UNKNOWN. THE PRODUCT WAS AVAILABLE FOR RETURN. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 19696851 ↗
• InjuryJun 14, 2024Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) CAME OUT TOO FAST. THE INJECTOR IS BEHIND SO IT CAME OUT A BIT. THE LENS WAS PARTIALLY INSERTED INTO THE RIGHT EYE. THE PATIENT¿S CAPSULE BROKE AND SUTURES WERE USED. USING SUTURES IS NOT THE DOCTOR¿S STANDARD PRACTICE BUT THEY WERE USED AS PRECAUTIONARY MEASURE. NO VITRECTOMY WAS REQUIRED. THE PROCEDURE WAS COMPLETED WITH AN IOL OF THE SAME MODEL AND DIOPTER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 19543254 ↗
• InjuryMay 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED. THROUGH FOLLOW-UP, WE LEARNED THAT THE IOL REMOVAL WAS NOT DUE TO A MATERIAL DEFECT OR SIMILAR, BUT TO A SPECIAL SURGICAL SITUATION. AFTER UNDERGOING EXTERNAL CATARACT SURGERY WITH CAPSULE RUPTURE, THE INITIAL PLAN FOR INTRACAPSULAR IMPLANTATION WAS UNSUCCESSFUL. AS A RESULT, THE PATIENT REQUIRED IOL REMOVAL FOLLOWED BY THE IMPLANTATION OF A NEW IOL WITH A 0.5 DIOPTER REDUCTION INTO THE SULCUS. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 19294159 ↗
• 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 19265365 ↗
• MalfunctionFeb 1, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAS ONLY ONE HAPTIC AND WAS UNUSABLE. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18627362 ↗
• MalfunctionDec 15, 2023Break; Break

  IT WAS REPORTED THERE WAS HAPTIC DAMAGED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18337036 ↗
• MalfunctionDec 13, 2023Break; Break

  IT WAS REPORTED THERE WAS HAPTIC BENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18321003 ↗
• MalfunctionDec 1, 2023Break; Break

  IT WAS REPORTED THAT NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS FULLY INSERTED. ONE HAPTIC KINKED AND APPEARED FRAYED. THERE WAS NO PATIENT INJURY. NO INCISION ENLARGEMENT, NO UNPLANNED SUTURES AND NO UNPLANNED VITRECTOMY. THE SURGERY WAS COMPLETED SUCCESSFULLY USING BACKUP IOL OF SAME MODEL AND DIOPTER IN THE SAME PROCEDURE. LENS IS NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18247374 ↗