SENSAR IOL AR40E (REF AR40E00040)Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 05050474501867), received between Aug 22, 2016 and Nov 25, 2025 — classified as 11 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Break” (14 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 29 reports, in the reporter's own words as published by the FDA.

• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE AR40E MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE). DUE TO COMPLAINTS OF PROMINENT GLARE AND HALO, WHICH RESULTED IN DIFFICULTIES WITH COMPUTER USE AND READING, AND LED TO THE PATIENT'S INABILITY TO PERFORM ONE OR MORE DAILY ACTIVITIES FOLLOWING SURGERY. AT A POST-OPERATIVE VISIT, UNDER-CORRECTION WAS NOTED, AND THE PATIENT REQUESTED A LENS EXCHANGE. THE ORIGINAL LENS WAS EXPLANTED DURING A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH AN AR40E 5.0 IOL. THERE WAS NO PRODUCT QUALITY ISSUE THAT CONTRIBUTED TO THE IOL EXPLANT DECISION. THERE WERE NO COMPLICATIONS, NO INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY, NO SUTURES, AND NO VITRECTOMY DURING THE LENS EXCHANGE PROCEDURE. PATIENT¿S PROGNOSIS POST LENS EXCHANGE WAS REPORTED AS EXPECTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Halo; Visual Disturbances; Visual Impairment

  MAUDE report 23641038 ↗
• InjuryNov 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LEFT EYE MANUFACTURER REPORT NUMBER 3012236936-2025-0003026. IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S LEFT EYE. AT THE PATIENT¿S FOLLOW-UP VISIT THE DOCTOR DETERMINED HYPEROPIC ERROR. THE SYMPTOMS WERE REPORTED AS AFFECTING THE PATIENT ABILITY TO PERFORM ONE OR MORE DAILY ACTIVITIES. THE IOL IS SIMPLY NOT THE BEST DIOPTER FOR THE PATIENT. THE IOL WAS EXPLANTED AND REPLACED WITH ANOTHER JOHNSON AND JOHNSON LENS MODEL AR40E 7.5 DIOPTER. THERE WERE NO COMPLICATIONS SUCH AS A CAPSULE TEAR, VITRECTOMY OR SUTURES. THE PATIENT IS DOING WELL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 23612897 ↗
• MalfunctionOct 1, 2024Break; Break

  BENT HAPTIC WAS REPORTED FOLLOWING THE IMPLANTATION OF THE NON PRE-LOADED AR40E MODEL INTRAOCULAR LENS (IOL). THE IOL WAS CUT OUT DURING THE SAME PROCEDURE AND REPLACED WITH A BACK-UP AR40E 4.0 DIOPTER IOL THAT WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE). DURING THE PROCEDURE, THERE WAS NO INCISION ENLARGEMENT, SERIOUS PATIENT INJURY, SUTURES, NOR VITRECTOMY. PATIENT PROGNOSIS POST-PROCEDURE WAS REPORTED AS EXPECTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20347734 ↗
• 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 19265254 ↗
• MalfunctionDec 28, 2023Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS FULLY IMPLANTED IN A PATIENT¿S RIGHT EYE AND REMOVED IN THE SAME PROCEDURE DUE TO BROKEN HAPTIC. A REPLACEMENT LENS OF THE SAME MODEL BUT LOWER DIOPTER (3.5 D) WAS SUCCESSFULLY IMPLANTED. IT WAS INDICATED THAT SUTURES WERE REQUIRED. THE PATIENT IS WELL. THE PRODUCT IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED. THE SAME ISSUE REPORTED WITH TWO AR40E LENSES. THIS REPORT IS FOR THE LENS WITH SN (B)(6). A SEPARATE REPORT WILL BE SUBMITTED FOR THE OTHER LENS.

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

  MAUDE report 18415970 ↗
• MalfunctionDec 28, 2023Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS FULLY IMPLANTED IN A PATIENT¿S RIGHT EYE AND REMOVED IN THE SAME PROCEDURE DUE TO BROKEN HAPTIC. A REPLACEMENT LENS OF THE SAME MODEL BUT LOWER DIOPTER (3.5 D) WAS SUCCESSFULLY IMPLANTED. IT WAS INDICATED THAT SUTURES WERE REQUIRED. THE PATIENT IS WELL. THE PRODUCT IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED. THE SAME ISSUE REPORTED WITH TWO AR40E LENSES. THIS REPORT IS FOR THE LENS WITH SN (B)(6). A SEPARATE REPORT WILL BE SUBMITTED FOR THE OTHER LENS.

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

  MAUDE report 18407538 ↗
• MalfunctionNov 29, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS FULLY IMPLANTED AND THEN REMOVED AND REPLACED FROM THE LEFT EYE DURING THE SAME PROCEDURE DUE TO THE HAPTIC BREAKING OFF. ANOTHER JOHNSON AND JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (SAME MODEL AND DIOPTER). THERE WAS NO PATIENT INJURY AND NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE PATIENT IS DOING WELL POST-OPERATIVE. THE ISSUE WAS NOT DUE TO USE ERROR. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18234260 ↗
• InjuryMay 26, 2023Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO A PATIENT'S EYE. DURING UNFOLDING, THE TRAILING HAPTIC WAS IN A "HORSESHOE" SHAPE. THE SURGEON WAITED BUT THE HAPTIC DID NOT RECOVER TO THE REQUIRED SHAPE OR POSITION, SO THE IOL WAS REMOVED AND A NEW LENS WAS IMPLANTED. THE INCISION WAS ENLARGED AND SUTURES WERE REQUIRED. IT IS UNKNOWN IF THE PATIENT'S DAILY ACTIVITIES WERE SIGNIFICANTLY AFFECTED. WE LEARNED THROUGH FOLLOW UP THAT THE PATIENT WAS FINE AFTER THE PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 17015272 ↗
• MalfunctionMay 2, 2023Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS PARTIALLY INSERTED, WAS REMOVED, DUE TO BENT/BROKEN HAPTIC AND THEN BACK-UP LENS WAS IMPLANTED . THERE WAS PATIENT CONTACT. PROCEDURE SUCCESSFULLY COMPLETED WITH BACK-UP IOL. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16857844 ↗
• InjuryMar 1, 2023Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD A KINKED HAPTIC FOLLOWING INSERTION INTO THE PATIENT'S OPERATIVE EYE. LOADING OF THE IOL WAS THE ISSUE. THE IOL WAS REMOVED AND REPLACED WITH THE SAME MODEL LENS. INCISION WAS ENLARGED AND SUTURES WERE REQUIRED. NO FURTHER INFORMATION RECEIVED.

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

  MAUDE report 16464631 ↗
• MalfunctionNov 17, 2022Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAPTIC BENT WHILE INSERTING INTO THE PATIENT'S OPERATIVE EYE. THE LENS WAS FULLY INSERTED AND REMOVED DURING THE SAME PROCEDURE. A REPLACEMENT IOL WAS USED. THERE WAS NO DAMAGE TO THE PATIENTS EYE AND NO PATIENT INJURY. THERE WAS NO DELAY IN TREATMENT OR NO MEDICAL OR SURGICAL INTERVENTIONS REQUIRED. THE PATIENT IS DOING GOOD POST-OPERATIVELY. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15821303 ↗
• MalfunctionOct 25, 2022Material Fragmentation; Use of Device Problem; Material Fragmentation; Use of Device Problem

  IT WAS REPORTED THAT DURING LOADING, THE LEADING HAPTIC WAS NOT TURNING TO THE RIGHT DIRECTION. DOCTOR ADJUSTED TO FIT INTO THE CARTRIDGE TO THE SUPPOSED POSITION. AFTER FEW ATTEMPTS IT WAS POSITIONED RIGHT, AND IT WAS THEN INJECTED INTO THE EYE. HALFWAY INTO THE EYE, IT WAS NOTED THAT THE LEADING HAPTIC WAS MISSING. SO, THE WHOLE IOL WAS REMOVED FROM THE EYE. LENS WAS PARTIALLY INSERTED AND REMOVED. THERE WAS A DELAY OF 20 MINUTES IN PROCEDURE. THERE WERE NO MEDICAL OR SURGICAL INTERVENTIONS SUCH AS INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES REPORTED, AND NO EXTRA MEDICATION WAS PRESCRIBED. THE ISSUE DID NOT AFFECT PATIENT'S ACTIVITIES OF DAILY LIFE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15671226 ↗
• MalfunctionJun 27, 2022Break; Inaccurate Delivery; Break; Inaccurate Delivery

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAPTIC WAS 'VERY FAULTY', IT WAS BENT. ACCOUNT INDICATED THAT THE IOL WAS PARTIALLY PLACED IN THE PATIENT'S LEFT EYE. THE IOL WAS REMOVED AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A BACK-UP LENS OF THE SAME MODEL. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION PERFORMED. PATIENT WAS DOING FINE POST-OPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14838218 ↗
• InjuryApr 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS INITIALLY REPORTED BY THE PATIENT (PT), THAT AFTER THE IOL WAS IMPLANTED IN THE RIGHT EYE (OD), THE LENS WAS REFRACTING LIGHT IN THE PERIPHERAL, CREATING A RAINBOW PRISM. AFTER SURGERY THERE WERE ¿SOME BLOOD AND AIR POCKETS¿ BEHIND THE OD. THE PT NOTED THE PROCEDURE WAS PAINFUL, AS THE PT WAS ONLY SEDATED ¿A LITTLE.¿ THROUGH FOLLOW-UP WITH THE PT, IT WAS LEARNED THAT THE VISUAL SYMPTOMS FLUCTUATE BETWEEN A COMPLETE CIRCLE AND HALF-MOON FROM THE LEFT OF THE IOL TOWARDS THE NOSE. IF THE EYE SHIFTS RIGHT AND BACK AGAIN, THERE ARE TWO REFRACTIVE LIGHTS AND FEELS ALMOST AS IF THE LENS IS MOVING. THERE IS A FLASH OF LIGHT FOR 2-3 SECONDS AS IF SOMETHING IS APPROACHING FROM THE RIGHT SIDE. THE PT REPORTED NO LONGER BEING ABLE TO DRIVE AT NIGHT, DUE TO THE PRISM LIGHT WHICH COMES AND GOES WITH STREETLIGHTS. THE PT HAS TROUBLE READING BECAUSE OF THIS ISSUE. THE ISSUE IS WORSE WHEN NOT WEARING THE CONTACT LENS. DURING SURGERY THE DOCTOR PERFORMED A MANUAL STITCH. THE PT LOOKED DOWN AFTER SURGERY AND SAW ¿TWO BLACK DOTS¿ IN VISION. THE DOCTOR ADVISED THAT THOSE WERE TWO DOTS OF BLOOD. THE PT HAD "AIR POCKETS" THAT ARE NO LONGER THERE. THROUGH FOLLOW-UP WITH A REPRESENTATIVE AT THE SURG

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

  MAUDE report 14058469 ↗
• MalfunctionMar 16, 2022Break; Break

  IT WAS REPORTED THAT A FULLY IMPLANTED INTRAOCULAR LENS (IOL) WAS REMOVED AND REPLACED DURING THE INITIAL SURGERY DUE TO OBSERVING THAT THE LEADING HAPTIC BROKE. ACCOUNT INDICATED THAT THE INCISION WAS ENLARGED TO REMOVE THE LENS FROM THE PATIENT'S RIGHT EYE. THERE WAS NO FURTHER MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE LENS IS NOT AVAILABLE FOR EVALUATION. THE PATIENT HAS REPORTEDLY FULLY RECOVERED. NO FURTHER INFORMATION AVAILABLE.

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

  MAUDE report 13784507 ↗
• MalfunctionJan 27, 2022Inaccurate Delivery; Scratched Material; Inaccurate Delivery; Scratched Material

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS PARTIALLY INSERTED INTO PATIENT'S LEFT EYE, HOWEVER, WAS REMOVED AS THE IOL WAS SCRATCHED. ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND DIOPTER) WAS IMPLANTED AS A REPLACEMENT. THE PATIENT HAS RECOVERED. THE ORIGINAL LENS WAS DISCARDED. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13375187 ↗
• MalfunctionApr 2, 2021Break; Failure to Fold; Break; Failure to Fold

  IT WAS REPORTED THAT THERE WAS FOLDING ISSUE WITH THE LEADING HAPTIC. IMPLANTATION WAS HALTED (DELAYED) BECAUSE INTRAOCULAR LENS (IOL) RETRACTED FROM THE EYE BUT IOL WAS NOT FULLY IMPLANTED. THE IOL CHECKED UNDER MICROSCOPE AND LEADING HAPTIC OUT OF SHAPE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11610214 ↗
• MalfunctionFeb 11, 2021Break; Break

  IT WAS REPORTED THAT THE LENS WAS DAMAGED IN THE CARTRIDGE. THERE WAS NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11318711 ↗
• MalfunctionJan 4, 2021Failure to Unfold or Unwrap; Physical Resistance/Sticking; Failure to Unfold or Unwrap; Physical Resistance/Sticking

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD UNFOLDING ISSUE AND HAPTIC STUCK TO OPTIC. THROUGH FOLLOW-UP, IT WAS LEARNED THE LENS WAS INSERTED AND REMOVED DURING THE SAME-PROCEDURE AS THE OPTIC WOULD NOT UNFOLD. THE LENS WAS DISCARDED. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED. A NEW LENS WAS IMPLANTED. THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11111740 ↗
• InjuryAug 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LENS WAS EXPLANTED FROM PATIENT¿S RIGHT EYE IN SECONDARY SURGICAL PROCEDURE BECAUSE OF PATIENT EXPERIENCING UNEXPECTED POST OP REFRACTION. THERE WAS NO INCISION ENLARGEMENT. PATIENT HAS RECOVERED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10365237 ↗
• MalfunctionDec 6, 2019Failure to Unfold or Unwrap; Improper or Incorrect Procedure or Method; Human-Device Interface Problem; Failure to Unfold or Unwrap; Improper or Incorrect Procedure or Method; Human-Device Interface Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD HANDLING PROBLEM,UNFOLDING ISSUE AND WAS IMPROPERLY LOADED. THERE WAS CONTACT WITH THE PATIENT¿S RIGHT EYE. THE LENS WAS REMOVAL AND REPLACEMENT. THERE WAS NO INCISION ENLARGEMENT OR VITRECTOMY PERFORMED. HOWEVER, A SUTURE WAS PLACED AS A RESULT OF A LEAK OF THE WOUND AT THE END OF THE SURGERY, THEREFORE A SUTURE ON THE WOUND IN TEMPORAL (2.2). THE REPLACEMENT LENS WAS THE SAME MODEL BUT A HALF DIOPTER HIGHER. THE PATIENT WAS DOING GOOD WHEN DISCHARGED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9422098 ↗
• InjurySep 23, 2019Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WOULD NOT UNFOLD, THEREFORE, THE LENS WAS EXPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available

  MAUDE report 9107574 ↗
• MalfunctionAug 20, 2018Scratched Material; Scratched Material

  IT WAS REPORTED THAT A MODEL AR40E 4.0 DIOPTER LENS WAS NOTICED SCRATCHED DURING HANDLING AND PRIOR TO INSERTION WITH NO PATIENT CONTACT. THEREFORE, ANOTHER LENS WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7800068 ↗
• InjuryNov 9, 2017Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE HAPTIC OF A AR40E 4.0 DIOPTER INTRAOCULAR LENS (IOL) WAS NOTICED DISTORTED WHILE INSERTING INTO THE PATIENT'S LEFT EYE (OS). REPORTEDLY, THE LENS WAS NOT FULLY INSERTED. THE REPLACEMENT LENS WAS A NON-AMO LENS. THERE WAS A 1.8 MM INCISION ENLARGEMENT, BUT NO VITRECTOMY OR SUTURES WERE USED. THERE WAS NO PATIENT INJURY OR COMPLICATIONS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7015173 ↗
• InjuryAug 28, 2017Break; Detachment Of Device Component; Break; Detachment Of Device Component

  IT WAS REPORTED THAT THE TRAILING HAPTIC OF AN INTRAOCULAR LENS (IOL) BROKE OFF DURING INSERTION INTO THE EYE. REPORTEDLY, THE SURGEON HAD TO ENLARGED THE INCISION AND CUT THE LENS OUT. NO PATIENT COMPLICATIONS WERE REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6823311 ↗