SENSAR IOL AR40e (REF AR40E00245)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 05050474502192), received between Aug 28, 2018 and Jun 8, 2026 — classified as 9 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryJun 8, 2026Use of Device Problem

  IT WAS REPORTED THAT A MONOFOCAL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN A PATIENT, BUT SUBSEQUENTLY REMOVED DUE TO (D/T) INSTABILITY. AN ANTERIOR CHAMBER (AC) LENS WAS THEN INSERTED AS A REPLACEMENT. THROUGH FOLLOW UP, IT WAS LEARNED THAT AFTER PHACOEMULSIFICATION WAS COMPLETED, THE SURGEON NOTED THE INFERIOR ASPECT OF CAPSULAR BAG WAS FOUND DEFICIENT. IRRIGATION AND ASPIRATION OF THE CORTICAL MATERIAL WAS COMPLETED. HEALON WAS PLACED IN THE CAPSULAR BAG. THE IOL WAS INITIALLY INSERTED IN THE SULCUS, HOWEVER, DUE TO LACK OF CAPSULAR SUPPORT, THE LENS WAS NOTED TO BE SINKING. THE LENS WAS EXPLANTED AND REPLACED WITH A NON-JOHNSON & JOHNSON AC LENS OF 20.5 DIOPTER. INTRACAMERAL MIOCHOL AND KENALOG INJECTED AND AN ANTERIOR VITRECTOMY WAS PERFORMED. UNPLANNED SUTURES AND UNPLANNED INCISION ENLARGEMENT WAS REQUIRED. THE PATIENT WAS IN STABLE CONDITION AS THE AC LENS WAS SUCCESSFULLY IMPLANTED AND WAS REPORTED TO BE WELL UPON DISCHARGE. THE LENS WAS DISCARDED AND IS NOT AVAILABLE FOR RETURN OR EVALUATION. NO OTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 25436635 ↗
• MalfunctionApr 15, 2026Break

  THE FOLLOWING WAS REPORTED REGARDING THE JOHNSON (JNJ) INTRAOCULAR LENS (IOL). THE SURGEON INSERTED THE IOL INTO THE EYE AND THEN NOTICED THE HAPTIC WAS BENT. THE IOL WAS REMOVED AND REPLACED WITH AN ALTERNATIVE LENS. THE SURGEON EXPLAINED THAT IN HIS OPINION THE PRODUCT WAS NOT THE CAUSE NOR DID IT CONTRIBUTE TO THE EVENT WHICH THE CUSTOMER CLARIFIED AS FOLLOWS. SUBSEQUENTLY THE HAPTIC SLIPPED THROUGH THE SCLEROTOMY AND INTO THE POSTERIOR CHAMBER. THE HAPTIC WAS THEN NOTED TO BE BENT AND THE DECISION WAS MADE TO REMOVE THE LENS AND REPLACE IT. THERE WERE NO COMPLICATIONS SUCH AS A CAPSULE TEAR, VITRECTOMY, SUTURES OR MEDICATION OUTSIDE THE STANDARD OF CARE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24880695 ↗
• MalfunctionApr 8, 2026Device Dislodged or Dislocated

  IT WAS REPORTED BY THE CUSTOMER THAT ON (B)(6) 2026, DURING A SURGICAL PROCEDURE THE SURGEON IDENTIFIED AN ISSUE WITH AN IOL (INTRAOCULAR LENS). THE LENS WAS ATTEMPTED TO BE PLACED IN THE SULCUS BUT WAS DEEMED UNSTABLE AND WAS REMOVED DURING THE SAME PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24818351 ↗
• MalfunctionJan 16, 2026Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24100607 ↗
• MalfunctionOct 16, 2025Break; Break

  IT WAS REPORTED THAT A NON-PRELOADED THREE-PIECE SPHERICAL MONOFOCAL INTRAOCULAR LENS (IOL) HAPTIC WAS BROKEN. THE ISSUE WAS IDENTIFIED DURING THE IMPLANTATION OR APPLICATION PROCESS. THE LENS WAS INSERTED AND REMOVED DURING THE SAME PROCEDURE, RESULTING IN A DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23316725 ↗
• 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 22075202 ↗
• InjuryMay 8, 2025Break; Break

  IT WAS REPORTED THAT HAPTIC OF THREE PIECE MONOFOCAL NON-PRELOADED INTRAOCULAR LENS (IOL) WAS BROKEN WHILE IMPLANTING THE LENS. THE LENS WAS REMOVED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21990196 ↗
• MalfunctionMay 7, 2025Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS FULLY INSERTED; HOWEVER, AFTER INSERTION, IT WAS OBSERVED THAT ONE OF THE HAPTICS WAS KINKED, WHICH LED TO THE DECISION TO REMOVE THE IOL DURING THE SAME SURGICAL PROCEDURE AND REPLACE IT WITH A NEW IOL OF THE SAME MODEL AND DIOPTER STRENGTH. THERE WAS NO INJURY TO THE PATIENT AND NO ADDITIONAL INTERVENTIONS WERE NECESSARY. THE PATIENT IS CURRENTLY DOING WELL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21981713 ↗
• InjuryMay 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE. THE REASON FOR THE EXPLANT WAS NOT SPECIFIED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 19368250 ↗
• 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 19265166 ↗
• InjuryFeb 6, 2023Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS FULLY INSERTED INTO THE PATIENT'S RIGHT EYE AND REMOVED DURING THE SAME PROCEDURE AS THE IOL WAS LOADED INCORRECTLY APPEARING TO BE UPSIDE DOWN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A BACK UP LENS (SAME DIOPTER). THE INCISION WAS ENLARGED AND UNPLANNED SUTURES WERE REQUIRED, HOWEVER, A VITRECTOMY WAS NOT PERFORMED. ADDITIONAL INFORMATION WAS PROVIDED THAT UPON INSPECTION OF THE LENS AT INJECTION THE LEADING HAPTIC WAS NOTED TO BE BENT AND WOULD NOT SIT FLAT IN THE CAPSULAR BAG. THE DECISION WAS MADE TO REMOVE THE LENS USING MST (MICROSURGICAL TECHNOLOGY) FORCEPS AND LENS SCISSORS. THERE WAS NO PATIENT INJURY. NO OTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 16305970 ↗
• MalfunctionAug 11, 2022Scratched Material; Scratched Material

  IT WAS REPORTED THAT A SENSAR AR40E INTRAOCULAR LENS (IOL) WITH MARKINGS/SCRATCHES WAS IMPLANTED IN PATIENT'S EYE. THERE WAS NO DELAY IN PROCEDURE AND NO VITRECTOMY REQUIRED. THE LENS REMAINS IMPLANTED IN THE EYE AND NO IMPACT ON DAILY ACTIVITIES OF THE PATIENT REPORTED. THERE WAS NO REPLACEMENT. THE CUSTOMER INDICATED THAT THEY DID NOT INSPECT THE LENS PRIOR TO LOADING IT IN THE CARTRIDGE. NO PATIENT INJURY REPORTED. THE PATIENT OUTCOME WAS NOT PROVIDED. NO FURTHER INFORMATION PROVIDED. THIS EMDR REPORT IS FOR THE AR40E INTRAOCULAR LENS. A SEPARATE REPORT WILL BE PROVIDED FOR THE INTRAOCULAR EMERALDC30 CARTRIDGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15214874 ↗
• MalfunctionAug 8, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  CUSTOMER REPORTED A TORN SENSAR AR40E INTRAOCULAR LENS (IOL). NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15189164 ↗
• MalfunctionJul 9, 2021Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) BROKE AT THE POINT OF INJECTION, THE LENS WAS TAKEN OUT. NO PATIENT INJURY WAS REPORTED. DESPITE FOLLOWING UP, THE CUSTOMER DID NOT REVERT BACK TO US. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12147755 ↗
• InjuryMay 7, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT LENS WAS NOT IMPLANTED FOR INTRAOPERATIVE COMPLICATION. AFTER FOLLOW-UP WE LEARNED THAT DURING THE SURGERY THERE WAS A POSTERIOR CAPSULAR RUPTURE. IT WAS STATED THAT THE LENS DID NOT GUARANTEE STABILITY AS IT MOVED IN THE VITREOUS SO FOR THAT REASON IT WAS REMOVED. NO PATIENT IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Capsular Bag Tear

  MAUDE report 11791535 ↗
• InjuryAug 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SENSAR MONOFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S EYE DUE TO THE NEED FOR NEW LENS POWER FOR PATIENT TO REACH THE INTENDED VISION. THE REPLACEMENT LENS IS THE SAME MODEL HIGHER DIOPTER (26.5) IOL. THERE WERE NO SUTURES OR INCISION ENLARGEMENT REQUIRED. REPORTEDLY, PATIENT IS DOING WELL POST-OPERATION. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10393859 ↗
• MalfunctionAug 30, 2019Contamination; Contamination

  IT WAS REPORTED THAT INTRAOCULAR LENS MODEL AR40 THAT WERE IMPLANTED HAD FILM ON THE EDGE THAT WAS VISIBLE WHEN SURGEON LOOKED THROUGH THE MICROSCOPE AFTER ASPIRATION. CUSTOMER WAS NOT SURE WHERE THE FILM WAS COMING FROM. THIS REPORT CAPTURED INFORMATION FOR ONE LENS. OTHER REPORTS ARE BEING SUBMITTED FOR OTHER LENSES. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8950446 ↗
• InjuryMar 5, 2019Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL), IMPLANTED IN THE LEFT EYE, WAS REMOVED AND REPLACED DURING THE INITIAL PROCEDURE. CUSTOMER REPORTED LOADING ISSUES WITH TROUBLE DELIVERING THE LENS IMPLANT. THE LENS BECAME STUCK IN THE ENTRY WOUND AND HAD TO BE CUT OUT AND REMOVED. REPLACEMENT IMPLANT WAS SUCCESSFULLY DELIVERED. WOUND WAS SUTURED. THE CASE WAS COMPLETED WITHOUT FURTHER INCIDENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8392979 ↗
• InjuryOct 17, 2018Break; Break

  IT WAS REPORTED THAT THE MONOFOCAL INTRAOCULAR LENS (MODEL AR40E, +24.5 DIOPTER) HAPTIC TORE WHILE INSERTING INTO THE EYE. THE LENS WAS REMOVED AND REPLACED IN THE SAME PROCEDURE. REPORTEDLY A VITRECTOMY, INCISION ENLARGEMENT AND SUTURES WERE REQUIRED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available; Vitrectomy

  MAUDE report 7976210 ↗
• InjuryAug 28, 2018Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING IMPLANTATION OF THE INTRAOCULAR LENS (IOL) THE PATIENT'S POSTERIOR CAPSULE WAS BROKEN BY THE LENS LEAD HAPTIC. IT WAS ALSO NOTED THAT THE LENS WAS DEFECTIVE. NO ADDITIONAL INFORMATION WAS PROVIDED. THE SAME ISSUE WAS REPORTED FOR 2 LENSES, THEREFORE 2 MDRS WILL BE FILED. THIS REPORT IS THE SECOND OF 2.

  Patient problems: Capsular Bag Tear

  MAUDE report 7822017 ↗