SENSAR IOL AR40e (REF AR40E00180)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 05050474502062), received between Nov 20, 2016 and May 22, 2026 — classified as 7 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH NON-PRELOADED MONOFOCAL INTRAOCULAR LENSES (IOLS) IN BOTH EYES, WITH SURGERIES PERFORMED WITHIN A TWO-WEEK INTERVAL. YTTRIUM-ALUMINUM-GARNET (YAG) LASER CAPSULOTOMY WAS CONDUCTED IN BOTH EYES APPROXIMATELY 30 DAYS POSTOPERATIVELY FOR TREATMENT OF SCAR TISSUE, PER PATIENT REPORT. THE PATIENT HAS A MEDICAL HISTORY OF RETINOPATHY, WITH APPROXIMATELY 4¿5 PRIOR LASER PROCEDURES PERFORMED IN BOTH EYES BEFORE CATARACT SURGERY. POSTOPERATIVELY, THE PATIENT INDICATED THAT UNCORRECTED VISION WAS SATISFACTORY; HOWEVER, WHEN USING PRESCRIPTION EYEGLASSES, A PERSISTENT YELLOW TINT WAS PERCEIVED, RATED AS 1/10 WITH THE INITIAL PAIR AND 4.5/10 WITH A SECOND PAIR OF TRANSITIONAL LENSES. THE PATIENT DECLINED THE SECOND PAIR DUE TO THE SAME ISSUE. THE EYEGLASS TECHNICIAN ALSO REPORTEDLY OBSERVED A SLIGHT YELLOW TINT WHEN VIEWING THROUGH THE EYEGLASSES. THE TREATING PHYSICIAN WAS UNABLE TO DETERMINE THE CAUSE OF THE YELLOW TINT ASSOCIATED WITH GLASSES USE. DESPITE OVERALL GOOD VISUAL ACUITY, THE PATIENT REPORTED INCONVENIENCE REQUIRING THE USE OF SUNGLASSES OVER PRESCRIPTION GLASSES WHILE DRIVING. THE PATIENT ELECTED TO USE CLIP-ON/FLIP-UP SUNGLASSES

  Patient problems: Posterior Capsule Opacification

  MAUDE report 25257349 ↗
• MalfunctionApr 17, 2025Break; Break

  IT WAS REPORTED THAT DURING IMPLANTATION OF THE NON-PRELOADED INTRAOCULAR LENS (IOL), THE HAPTIC BROKE WHEN ATTEMPTING TO REMOVE THE LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21862002 ↗
• InjuryJan 9, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE NON-PRELOADED MONOFOCAL LENS WAS LOADED INCORRECTLY AND THIS WAS IDENTIFIED DURING IMPLANTATION. AS A RESULT, THE PROCEDURE WAS DELAYED AND THE PATIENT REQUIRED UNPLANNED SUTURES. THE PATIENT IS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 21120517 ↗
• MalfunctionDec 30, 2024Break; Break

  IT WAS REPORTED THAT THE NON-PRELOADED MONOFOCAL LENS HAD A BENT HAPTIC. ADDITIONAL INFORMATION SUGGESTS THAT THE LENS WAS BOTH IMPLANTED AND SUBSEQUENTLY EXPLANTED DURING THE SAME PROCEDURE, AFTER WHICH A REPLACEMENT LENS WAS USED. THE PATIENT'S VISUAL ACUITY OUTCOME POST-OPERATION IS 20/20. NO INTERVENTIONS OR INJURIES WERE REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21039841 ↗
• MalfunctionSep 25, 2024Break; Break

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL LENS WAS IMPLANTED AND IMMEDIATELY EXPLANTED. IT WAS THEN REPLACED WITH THE SAME MODEL AND A LOWER DIOPTER J&J LENS. ADDITIONAL INFORMATION SUGGESTED THAT THE SURGEON COULD NOT GET THE HAPTICS TO LINE UP, LEADING TO THE DECISION TO REMOVE THE LENS. THE HAPTICS WERE BENT AND IT HAPPENED POSSIBLY DUE TO A USER ERROR OR A LOADING ERROR. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20302284 ↗
• MalfunctionFeb 6, 2023Break; Break

  IT WAS REPORTED THAT DURING IMPLANTATION OF THE INTRAOCULAR LENS (IOL) INTO PATIENT'S OPERATIVE EYE, IT WAS IDENTIFIED THAT THE LENS WAS FAULTY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16308646 ↗
• InjuryDec 9, 2022Break; Break

  IT WAS REPORTED THAT THERE WAS A HAPTIC DEFECT. THE INTRAOCULAR LENS (IOL) WAS EXPLANTED AND A NEW IOL OF THE SAME MODEL AND DIOPTER WAS IMPLANTED. NO FURTHER DETAILS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15955252 ↗
• MalfunctionApr 29, 2021Difficult to Insert; Defective Component; Difficult to Insert; Defective Component

  IT WAS REPORTED THAT THE PATIENT WAS DIAGNOSED WITH APHAKIA IN THE LEFT EYE AND MCCANNAL SUTURE PARS PLANA APPROACH PROCEDURE WAS BOOKED. THE SUSPECT INTRAOCULAR LENS (IOL) WAS INSERTED INTO PATIENT'S EYE, HOWEVER, DID NOT STAY IN PLACE DUE TO LACK OF SUPPORT AS THE HAPTICS WERE TOO SHORT. THE LENS WAS REMOVED WITH NO INJURY AND REPLACED WITH ANOTHER LENS OF DIFFERENT MODEL. ADDITIONALLY, A 10-0 NYLON SUTURE WAS USED. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11750154 ↗
• InjuryJan 8, 2020Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT AN AR40E INTRAOCULAR LENS (IOL) WAS IMPLANTED BUT AFTER 18 YRS. OF THE DOCTOR NOT SEEING THE PATIENT, THE PATIENT PRESENTED HERSELF TO THE DOCTOR WITH A DISLOCATED LENS BAG COMPLEX WITH PSEUDOEXFOLIATION GLAUCOMA IN THE RIGHT EYE. IT WAS NOTED THAT THE LENS ROTATED. THE PATIENT REPORTED BLURRY VISION AND INCREASED INTRAOCULAR PRESSURE (IOP). THE DOCTOR DID LENS REPOSITIONING, GONIO-ASSISTED TRANSLUMINAL TRABECULECTOMY, AND PARS PLANA VITRECTOMY OF THE RIGHT EYE. VISION IS NOW GOOD AND IOP IS DOWN. NO PATIENT POST-OP INJURY. THE LENS REMAINS IMPLANTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Intraocular Pressure Increased; Vitrectomy

  MAUDE report 9567098 ↗
• InjuryDec 17, 2019Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAD A DAMAGED HAPTIC. THE LENS WAS PARTIALLY INSERTED INTO THE RIGHT EYE AND REMOVED AND REPLACED DURING THE SAME PROCEDURE. AN INCISION ENLARGEMENT WAS REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9485486 ↗
• MalfunctionNov 11, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT WHEN THE INTRAOCULAR LENS (IOL), MODEL AR40E 18.0 DIOPTER WAS IMPLANTED IN THE EYE, THE TRAILING HAPTIC WAS RELEASED IN A FOLDED STATE. THIS PROBLEM WAS NOT RESOLVED EVEN WHEN OVD (OPHTHALMIC VISCOSURGICAL DEVICE) WAS ASPIRATED WITH IRRIGATION/ASPIRATION (I/A). THE LENS WAS CUT WITH A LENS CUTTER AND IT WAS EXPLANTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE BACK UP IOL. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9304633 ↗
• MalfunctionMar 4, 2019Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) LENS HAD A KINKED HAPTIC, THEREFORE, THE SURGEON REQUESTED FOR A NEW LENS. THERE WAS PATIENT CONTACT. THROUGH FOLLOW UP, THE CUSTOMER CONFIRMED ONLY THE CARTRIDGE TIP TOUCHED THE EYE. THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8385094 ↗
• InjuryDec 18, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A AR40E 18.0 DIOPTER INTRAOCULAR LENS (IOL) WAS REMOVED FROM THE PATIENT''S OPERATIVE EYE FOR UNKNOWN REASONS AND A VITRECTOMY WAS REQUIRED. THERE WAS NO INCISION ENLARGEMENT OR SUTURES USED. THE PATIENT LEFT APHAKIC. THE PATIENT RETURNED ON (B)(6) 2017 AND A NON-AMO LENS WAS IMPLANTED. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT''S STATUS POST EXCHANGE STATUS IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Vitrectomy

  MAUDE report 7125079 ↗
• MalfunctionOct 25, 2017Material Discolored; Device Contamination with Chemical or Other Material; Material Discolored; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (MODEL AR40E, +18.0 DIOPTER) WAS IMPLANTED IN THE EYE OF A MALE PATIENT ON (B)(6) 2016. THE LENS WAS EXPLANTED ON (B)(6) 2017 BECAUSE THE SURGEON NOTICED A "PUTTY" ON THE LENS THAT WAS CAUSING LOSS OF VISION. ANOTHER AR40E, WITH THE SAME DIOPTER SIZE, WAS INSERTED INTO THE EYE BUT THE SURGEON NOTICED THAT THIS LENS WAS FOGGY, NOT QUITE CLEAR, AND IT HAD SOME SUBSTANCE ON THE ANTERIOR OF THE LENS. REPORTEDLY, THE LENS WAS REMOVED AND REPLACED DURING THE SAME SURGICAL PROCEDURE WITH A PCB00 LENS. THE PATIENT VISION WAS REPORTED BEING NORMAL. NO FURTHER INFORMATION WAS PROVIDED. TWO MDRS WILL BE FILED FOR THE 2 AR40E LENSES. THIS REPORT IS TO RECORD THE SECOND AR40E LENS THAT WAS INSERTED AND REMOVED ON (B)(6) 2017.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6978927 ↗
• InjuryOct 25, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (MODEL AR40E, +18.0 DIOPTER) WAS IMPLANTED IN THE EYE OF A MALE PATIENT ON (B)(6) 2016. THE LENS WAS EXPLANTED ON (B)(6) 2017 BECAUSE THE SURGEON NOTICED A "PUTTY" ON THE LENS THAT WAS CAUSING LOSS OF VISION. ANOTHER AR40E, WITH THE SAME DIOPTER SIZE, WAS INSERTED INTO THE EYE BUT THE SURGEON NOTICED THAT THIS LENS WAS FOGGY, NOT QUITE CLEAR, AND IT HAD SOME SUBSTANCE ON THE ANTERIOR OF THE LENS. REPORTEDLY, THE LENS WAS REMOVED AND REPLACED DURING THE SAME SURGICAL PROCEDURE WITH A PCB00 LENS. THE PATIENT VISION WAS REPORTED BEING NORMAL. NO FURTHER INFORMATION WAS PROVIDED. TWO MDRS WILL BE FILED FOR THE 2 AR40E LENSES. THIS REPORT IS TO RECORD THE FIRST AR40E LENS IMPLANTED AND SUBSEQUENTLY EXPLANTED.

  Patient problems: Loss of Vision; No Code Available

  MAUDE report 6978924 ↗
• MalfunctionNov 20, 2016Device Contamination with Chemical or Other Material; Scratched Material; Device Contamination with Chemical or Other Material; Scratched Material

  IT WAS REPORTED THAT JUST AFTER THE IMPLANTATION OF AN INTRAOCULAR LENS (IOL), AN OILY SUBSTANCE OR A SCRATCH MARK WAS OBSERVED ON THE OPTIC SURFACE. IT COULD NOT BE REMOVED WITH THE IRRIGATION/ASPIRATION (I/A) PROCEDURE; THEREFORE THE SURGEON REMOVED AND REPLACED THE LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6116021 ↗