SENSAR IOL AR40e (REF AR40E00205)Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 05050474502116), received between Sep 13, 2017 and Jun 9, 2026 — classified as 19 injuries, 19 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. 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 38 reports, in the reporter's own words as published by the FDA.

• InjuryJun 9, 2026Material Fragmentation

  IT WAS REPORTED THAT NON-PRELOADED THREE-PIECE INTRAOCULAR LENS WAS INSERTED BY THE SURGEON AFTER A POSTERIOR CAPSULAR RUPTURE (PCR) OCCURRED. DURING INSERTION, A HAPTIC DETACHED FROM THE OPTIC, AND THE SURGEON CUT THE OPTIC IN THE ANTERIOR CHAMBER TO REMOVE THE LENS. THE PATIENT WAS LEFT APHAKIC, AND REIMPLANTATION OF A SULCUS LENS WAS PLANNED ONE WEEK LATER. ADDITIONAL INFORMATION INDICATED THAT THE POSTERIOR CAPSULAR RUPTURE (PCR) HAD NOT BEEN CAUSED BY THE INTRAOCULAR LENS. THE SURGEON HAD ATTEMPTED TO INSERT AN AR40E AFTER DISCOVERING THE RUPTURE DURING PHACO QUADRANT REMOVAL AND ATTRIBUTED THE TEAR PRIMARILY TO HYDRODISSECTION AND WEAKENING OF THE POSTERIOR CAPSULE. HYDRODISSECTION HAD BEEN PERFORMED WITH BALANCED SALT SOLUTION USING A SYRINGE AND CANNULA, AND NO J&J PRODUCT HAD BEEN USED. THE SURGEON ALSO STATED THAT THE RUPTURE WAS NOT DUE TO THE PHACO EQUIPMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25447537 ↗
• MalfunctionApr 20, 2026Break; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24933667 ↗
• MalfunctionMar 6, 2026Break

  IT WAS REPORTED THAT THE TRAILING HAPTIC OF THE NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS BENT IN THE LEFT EYE AS IT WAS BEING IMPLANTED. THROUGH FOLLOW-UP, IT WAS CONFIRMED THAT THE PROCEDURE WAS COMPLETED USING A BACKUP LENS. THE REPLACEMENT LENS WAS ANOTHER JOHNSON & JOHNSON LENS. IT IS UNKNOWN WHETHER THE DAMAGE WAS DUE TO USE ERROR. NO PATIENT INJURY WAS REPORTED. NO UNPLANNED MEDICAL OR SURGICAL INTERVENTIONS, SUCH AS VITRECTOMY OR SUTURES, WERE REQUIRED; HOWEVER, A LARGER INCISION WAS PERFORMED. THE PATIENT¿S OUTCOME IS STABLE. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 24533469 ↗
• InjuryMar 5, 2026Material Fragmentation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24527086 ↗
• MalfunctionDec 29, 2025Break; Break

  IT WAS REPORTED THAT THE NON-PRELOADED INTRAOCULAR LENS (IOL) CAME OUT DEFORMED FROM THE INSERTER. AS A RESULT, THE IOL CAME INTO CONTACT WITH THE PATIENT BUT IT WAS NOT IMPLANTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23917687 ↗
• InjuryDec 26, 2025Break; Break

  THE AR40E MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OPERATIVE EYE. DUE TO A HAPTIC ISSUE, THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH ANOTHER AR40E 20.5 IOL. PATIENT PROGNOSIS POST LENS EXCHANGE WAS REPORTED AS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23901160 ↗
• MalfunctionDec 5, 2025Break; Break

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS INSERTED INTO THE PATIENT¿S LEFT EYE. THE IOL WAS RIGID AND BROKE WHEN INSERTED INTO THE EYE. MST FORCEPS WERE USED TO REMOVE IT FROM THE EYE. THE IOL WAS REPLACED WITH THE SAME MODEL AND DIOPTER. THERE WERE NO COMPLICATIONS SUCH AS A CAPSULE TEAR, VITRECTOMY, SUTURES, INCISION ENLARGEMENT OR MEDS OUTSIDE THE STANDARD OF CARE. NO FURTHER INFORMATION WAS PROVIDED REGARDING THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23729956 ↗
• MalfunctionAug 6, 2025Break; Break

  IT WAS REPORTED THAT THE STANDALONE MONOFOCAL INTRAOCULAR LENS (IOL) HAPTIC WAS BROKEN. THROUGH FOLLOW-UP, IT WAS CONFIRMED THAT THE LENS AND CARTRIDGE WERE IN CONTACT WITH THE PATIENT'S EYE, BUT INSERTION WAS NOT COMPLETED. THE PATIENT DID NOT SUFFER ANY INJURIES, AND THE PROCEDURE WAS COMPLETED USING A REPLACEMENT LENS. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22734038 ↗
• MalfunctionJul 20, 2025Break; Break

  IT WAS REPORTED BY THE CUSTOMER THAT DURING THE IMPLANTATION OF THE NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) ON (B)(6) 2025, A HAPTIC WAS NOTED TO BE BROKEN WHILE MANIPULATING THE DEVICE TO CENTER IT. AS A RESULT, THE SPECIALIST EXPLANTED THE IOL, LEAVING THE PATIENT IN A STATE OF APHAKIA. ADDITIONAL INFORMATION REPORTED THAT THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT IOL IMPLANTATION, RESULTING IN APHAKIA IN THE LEFT EYE. NO EYE INJURY OCCURRED, THOUGH AN ANTERIOR VITRECTOMY WAS PERFORMED DUE TO SUPERIOR ZONULODIALYSIS. NO INCISION ENLARGEMENT OR OUTSIDE-STANDARD MEDICATION WAS NEEDED. SUTURES WERE PLACED AS PART OF STANDARD PRACTICE TO PREVENT INJURY. THE PATIENT'S VISION IMPROVED TO 6/12 AT 2 MONTHS POST-OP. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Zonular Dehiscence

  MAUDE report 22552183 ↗
• MalfunctionJun 20, 2025Break; Scratched Material; Break; Scratched Material

  IT WAS REPORTED BY THE CUSTOMER THAT AFTER THE IMPLANTATION OF A NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), A CRACK WAS OBSERVED ON THE OPTIC. THE INCISION WOUND WAS ENLARGED, AND THE LENS WAS SUCCESSFULLY EXPLANTED DURING THE SAME SURGICAL PROCEDURE. HOWEVER, ONE OF THE HAPTICS BROKE DURING THE EXPLANTATION PROCESS. THE CUSTOMER INDICATED THAT VITRECTOMY AND SUTURES WERE NECESSARY, AND MEDICATIONS WERE PRESCRIBED ACCORDINGLY, RESULTING IN A DELAY DURING THE PROCEDURE. THE DIRECTIONS FOR USE WERE FOLLOWED. THE PATIENT EXPERIENCED TEMPORARY IMPAIRMENT, WITH POST-OPERATIVE VISION RECORDED AT 6/120, A SIGNIFICANT DECREASE FROM THE PRE-OPERATIVE VISION OF 6/7.5. NO FURTHER INFORMATION IS AVAILABLE

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

  MAUDE report 22299490 ↗
• MalfunctionJun 7, 2025Break; Break

  IT WAS REPORTED THAT THE HAPTICS OF THE NON-PRELOADED INTRAOCULAR LENS (IOL) BROKE WHILE SURGEON WAS POSITIONING IOL IN EYE. DOCTOR SUBSEQUENTLY EXPLANTED THE LENS AND REIMPLANTED ANOTHER IOL IN THE SAME PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22163870 ↗
• InjuryMay 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING IMPLANTATION OF THE AR40E MODEL INTRAOCULAR LENS (IOL) THERE WERE COMPLICATIONS DURING SURGERY AND THE LENS WAS REMOVED; INFORMATION REGARDING THE REPLACEMENT IOL IS UNAVAILABLE. THERE WAS NO PRODUCT QUALITY ISSUE THAT CONTRIBUTED TO THE EVENT. PATIENT PROGNOSIS POST-PROCEDURE IS UNKNOWN. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 22090252 ↗
• MalfunctionFeb 9, 2025Break; Ejection Problem; Break; Ejection Problem

  IT WAS REPORTED THAT THE MONOFOCAL INTRAOCULAR LENS (IOL) WAS PARTIALLY INSERTED INTO A PATIENT'S LEFT EYE & REMOVED IN THE SAME PROCEDURE BECAUSE THE HAPTIC TWISTED (DAMAGED IN CARTRIDGE DURING INSERTION). THE PROCEDURE WAS COMPLETED USING ANOTHER LENS OF THE SAME DIOPTER (20.5D). 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 LEFT EYE. A SEPARATE REPORT IS BEING SUBMITTED FOR THE PATIENT'S RIGHT EYE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21341134 ↗
• InjuryFeb 7, 2025Material Fragmentation; Use of Device Problem; Material Fragmentation; Use of Device Problem

  IT WAS REPORTED TWO (02) PARACENTESIS WERE SUPERONASAL AND SUPEROTEMPORAL. THE AR40E MODEL INTRAOCULAR LENS (IOL) WAS LOADED AND INSERTED THROUGH THE CLEAR CORNEAL INCISION, TAKING CARE TO KEEP THE LEADING HAPTIC IN THE ANTERIOR CHAMBER AND THE TRAILING HAPTIC EXTERNALIZED. VISCOELATIC WAS INSTILLED INTO THE ANTERIOR CHAMBER TO COAT THE ENDOTHELIUM. BENT TSK NEEDLES AFFIXED TO NON-LOCKING TB SYRINGES FILLED WITH BALANCE SALT SOLUTION WERE THEN USED TO CREATE AN APPROXIMATELY 3MM TUNNEL, 3MM POSTERIOR TO THE LIMUBUS. THE TEMPORAL SCLERAL TUNNEL WAS CREATED FIRST. THE LEADING HAPTIC WAS GRASPED WITH SERRATED FORCEPS. HOWEVER, DURING THIS PROCESS A SMALL IRIDODIALYSIS AND IRIS HEMORRHAGE WAS CREATED. THE HAPTIC TIP WAS DOCKED INTO THE TSK NEEDLE BUT THERE WAS SIGNIFICANT RESISTANCE LEADING TO TRUNCATION OF THE HAPTIC. THIS SAME MANEUVER WAS ATTEMPTED AGAIN WITH 27G NEEDED BUT WITH THE SAME OUTCOME. THE HAPTIC WAS DEEMED TOO SHORT TO TUNNEL AND THUS WAS EXPLANTED IN A SIMILAR FASHION TO THE ABOVE. THE PROBLEM WAS CONFIRMED TO BE RELATED TO USE ERROR. THE SAME PROCEDURE WAS COMPLETED WITH ANOTHER AR40E 20.5 DIOPTER IOL THAT WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE). THER

  Patient problems: Eye Injury; Hyphema

  MAUDE report 21339941 ↗
• InjuryNov 1, 2024Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED THAT THE PHYSICIAN BROKE THE HAPTIC OF THE NON-PRELOADED INTRAOCULAR LENS (IOL) BECAUSE IT WAS LOADED INTO THE INJECTOR AND THE HAPTICS BECAME BENT. AS A RESULT, THE IMPLANT WAS REMOVED FROM THE PATIENT'S EYE, AND A REPLACEMENT IOL WAS IMPLANTED. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE PATIENT'S CATARACT WAS HARD AND A CAPSULE RUPTURE OCCURRED. THE PHYSICIAN DECIDED TO IMPLANT THE IOL IN THE SULCUS; HOWEVER, THE LEADING HAPTIC WAS BADLY BENT. THE INCISION WAS ENLARGED TO 4.2 MM AND SUTURED. A REPLACEMENT IOL WAS IMPLANTED DURING A SECONDARY PROCEDURE. 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 20593175 ↗
• InjuryOct 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANTATION OF THE 3 PIECE STANDALONE INTRAOCULAR LENS (IOL) WAS NOT POSSIBLE DUE TO A CAPSULE DAMAGE. SCLERAL FIXATION IOL. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 20424180 ↗
• InjuryOct 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANTATION OF THE 3 PIECE STANDALONE INTRAOCULAR LENS (IOL) WAS NOT POSSIBLE DUE TO A CAPSULE DAMAGE. SCLERAL FIXATION IOL. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 20423953 ↗
• InjuryJul 19, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT WHILE SCLERAL FIXATION WAS CONSIDERED, THE PRODUCT AND PLANNED SURGICAL PROCEDURE WERE DEEMED UNFEASIBLE, LEADING TO THE REMOVAL OF THE NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL). THE SURGERY WAS SUCCESSFULLY COMPLETED USING AN IOL FROM ANOTHER MANUFACTURER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE BACKUP LENS. NO PATIENT INJURY WAS REPORTED. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19783757 ↗
• 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 19265272 ↗
• 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 19263519 ↗
• MalfunctionApr 5, 2024Break; Break

  IT WAS REPORTED THAT THE HAPTIC OF A MONOFOCAL INTRAOCULAR LENS (IOL) SUFFERED DEFORMATION INSIDE THE INJECTOR, REQUIRING REPLACEMENT. THE LENS WAS FULLY INSERTED AND REMOVED FROM THE OPERATIVE EYE. IT WAS INDICATED THAT THE ISSUE WAS NOT DUE TO A USE ERROR. THE IOL TOUCHED THE EYE, AND THE HAPTIC ISSUE WAS NOTED. THE PROCEDURE WAS COMPLETED USING A NON-JOHNSON & JOHNSON LENS. THERE WERE NO SURGICAL INTERVENTIONS REQUIRED. THE PATIENT OUTCOME WAS GREAT AND NO INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19053415 ↗
• MalfunctionNov 27, 2023Break; Break

  IT WAS REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANT, IT WAS NOTICED THAT HAPTIC WAS DAMAGED AND NEW IOL WAS USED TO REPLACE IT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18212624 ↗
• MalfunctionJul 13, 2023Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS DEFECTIVE AND NEEDED TO BE REMOVED. ACCOUNT PROVIDED THAT THE IOL WAS REPLACED BY ANOTHER NON-JOHNSON AND JOHNSON LENS AND THAT THE PATIENT'S OUTCOME IS GOOD. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17322025 ↗
• InjuryJun 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS CHANGED. THERE WAS PATIENT CONTACT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 17235187 ↗
• InjuryMay 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH AN INTRAOCULAR LENS (IOL) IS UNABLE TO SEE CORRECTLY AFTER THE IMPLANTATION. PATIENT SOUGHT MEDICAL ATTENTION IN COLOMBIA. SHE IS UNABLE TO WORK, WALK, OR DRIVE. THROUGH FOLLOW UP, IT WAS LEARNED THE PATIENT'S VISUAL ISSUE IS DEBILITATING AS SHE CANNOT WORK, CAN'T DRIVE, AND WHEN SHE WALKS SHE HAS TO HOLD ONTO HER HUSBAND'S HANDS SO SHE DOES NOT FALL. THE PATIENT COMPLAINS THAT IT IS DIFFICULT TO SEE FACES OF PEOPLE. THE PATIENT WENT TO LIMA, PERU TO SEE A DOCTOR WHERE THEY PERFORMED A LASER TREATMENT SOMETIME IN (B)(6) 2023. THE LASER TREATMENT HELPED A LITTLE AND MEDICATIONS WERE PRESCRIBED. THE PATIENT IS WAITING TO SEE HER EYE SURGEON AND SEEKING A SECOND OPINION IN CANADA OR IN COLOMBIA. AT THIS TIME, THE IOL REMAINS IMPLANTED. NO OTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 17014974 ↗