SENSAR IOL AR40e (REF AR40E00190)Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 05050474502086), received between Nov 7, 2016 and Aug 25, 2026 — classified as 17 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Break” (17 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 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2026Break; Difficult to Insert

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

  MAUDE report 50439076 ↗
• MalfunctionJun 10, 2026Break

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS FULLY INSERTED INTO THE PATIENT¿S LEFT EYE. AFTER IMPLANTATION DAMAGED HAPTICS WERE OBSERVED. THE IOL WAS REMOVED DURING THE SAME PROCEDURE. AN UNPLANNED VITRECTOMY WAS PERFORMED, AND THE PROCEDURE WAS COMPLETED WITH A BACKUP LENS OF THE SAME MODEL AND DIOPTER. REPORTEDLY, THE DIRECTIONS FOR USE WERE FOLLOWED. THERE WAS NO INCISION ENLARGEMENT, SUTURES, OR DELAY IN PROCEDURE. THE PATIENT¿S STATUS WAS REPORTED AS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25460676 ↗
• 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 25257897 ↗
• InjuryMay 20, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE THE ATTEMPT TO IMPLANT THE INTRAOCULAR LENS (IOL) WAS UNSUCCESSFUL DUE TO PROBABLE INSTABILITY OF THE CAPSULAR BAG, RESULTING IN THE LENS DISLOCATING AND COMING INTO CONTACT WITH THE POSTERIOR CAPSULE. THE IOL COULD NOT BE RETURNED AS IT WAS CUT AND DISCARDED. CUSTOMER INDICATED THAT THE SURGERY WAS ALREADY A COMPLICATION DUE TO THE AFTER-EFFECTS OF CATARACT, THE SAC WAS ONLY PARTIALLY PRESENT. ANOTHER LENS TYPE WAS PLACED. NO INTERVENTION OUTSIDE THE STANDARD OF CARE WAS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 25232309 ↗
• InjuryMay 15, 2026Break

  IT WAS REPORTED THAT HAPTIC OF THREE PIECE MONOFOCAL NON-PRELOADED INTRAOCULAR LENS (IOL) WAS BROKEN. THERE WAS DELAY IN PROCEDURE. UNPLANNED SUTURES WERE REQUIRED. AS PER ADDITIONAL INFORMATION RECEIVED, DURING LENS INSERTION, IT WAS NOTED THAT HAPTIC WAS DISLODGED FROM OPTIC. IOL HAPTIC WAS BROKEN WHEN LENS CONTACTED CAPSULAR BAG. LENS WAS PARTIALLY INSERTED INTO PATIENT'S EYE AND REMOVED AT THE SAME TIME. PROCEDURE WAS COMPLETED USING BACKUP LENS OF SAME MODEL. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 25186763 ↗
• MalfunctionDec 29, 2025Break; Break

  IT WAS REPORTED THAT A NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) HAD A TORN OR BROKEN HAPTIC. ADDITIONAL INFORMATION WAS RECEIVED ON DECEMBER 12, 2025, THAT THE AFFECTED EYE WAS THE RIGHT EYE. THE PROCEDURE WAS COMPLETED USING A BACKUP LENS, AND AN ANTERIOR VITRECTOMY WAS PERFORMED. IT WAS CONFIRMED THAT THE INTRAOCULAR LENS CAME INTO CONTACT WITH THE EYE, AND THE DAMAGE WAS ATTRIBUTED TO USE ERROR. THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. THERE WAS NO PATIENT INJURY REPORTED. THE PATIENT WAS NOTED TO BE STABLE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23907201 ↗
• InjuryDec 16, 2025Break; Break

  A BENT UPPER HAPTIC OF THE AR40E MODEL INTRAOCULAR LENS (IOL) WAS NOTED AFTER IT'S PLACEMENT IN THE PATIENT'S EYE. THE LENS WAS REMOVED DURING THE SAME PROCEDURE AND A BACK-UP AR40E 19.0 DIOPTER IOL WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). THERE WAS NO SERIOUS PATIENT INJURY HOWEVER, THE INCISION WAS ENLARGED, UNPLANNED SUTURES WERE REQUIRED, AND AN UNPLANNED VITRECTOMY WAS PERFORMED. PATIENT PROGNOSIS POST-PROCEDURE WAS REPORTED AS HEALING WELL. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 23824213 ↗
• InjuryDec 12, 2025Break; Break

  IT WAS REPORTED THAT WHEN THE MODEL AR40E INTRAOCULAR LENS (IOL) WAS IMPLANTED, THE LENS HAPTIC SUDDENLY FRACTURED. THE HAPTIC LACERATED THE CAPSULE, PRODUCING AN APPROXIMATELY 5 × 5 MM ROUND TEAR IN THE CAPSULE, WHICH RESULTED IN RUPTURE OF THE ZONULAR FIBERS AND MADE IOL FIXATION IMPOSSIBLE. VISCOELASTIC WAS INJECTED, THE VITREOUS PROLAPSED INTO THE ANTERIOR CHAMBER WAS EXCISED WITH CAPSULAR SCISSORS, AND CORTICAL MATERIAL AND VISCOELASTIC WERE ASPIRATED WITH THE IRRIGATION/ASPIRATION DEVICE. CARBACHOL 1 ML WAS INJECTED TO INDUCE MIOSIS. THE WOUND WAS CLOSED WITH FOUR INTERRUPTED 10-0 NONABSORBABLE SUTURES. THE PATIENT WAS RETURNED TO THE WARD AT THE END OF THE PROCEDURE. POSTOPERATIVE DAY 1: ON ROUNDS, THE OPERATED EYE SHOWED DECREASED VISION BECAUSE NO IOL WAS IMPLANTED. THE SLIT-LAMP EXAM REVELED CONJUNCTIVAL INJECTION (+), DIFFUSE CORNEAL (STROMAL) EDEMA WITH ENDOTHELIAL FOLDS. THE PUPIL WAS ROUND, AND THE DIRECT AND INDIRECT PUPILLARY LIGHT REFLEXES WERE SLUGGISH. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Capsular Bag Tear; Chemosis; Corneal Edema; Vitreous Loss; Zonular Dehiscence

  MAUDE report 23795228 ↗
• MalfunctionOct 30, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED BY THE CUSTOMER THAT THE MONOFOCAL INTRAOCULAR LENS (IOL) DID NOT OPEN CORRECTLY, WITH NO INFORMATION IF THERE HAD BEEN PATIENT CONTACT. THROUGH FOLLOW UP WE LEARNED THAT THE LENS DID NOT UNFOLD IN THE ANTERIOR CHAMBER AND WAS REMOVED AND REPLACED DURING THE SAME SURGERY. ADDITIONAL INFORMATION PROVIDED CONFIRMED THAT THE PATIENT WAS NOT INJURED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23432826 ↗
• MalfunctionSep 9, 2025Break; Break

  IT WAS REPORTED THAT A NON-PRELOADED THREE-PIECE MONOFOCAL INTRAOCULAR LENS (IOL) WAS INSERTED, AND THE SURGEON REALIZED THAT THE LENS HAPTIC WAS KINKED. THE LENS WAS REMOVED AND REPLACED WITH A NEW THREE-PIECE MONOFOCAL IOL IN THE SAME SURGICAL PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23001339 ↗
• MalfunctionJun 12, 2025Break; Break

  IT WAS REPORTED BY THE CUSTOMER THAT THE NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS IMPLANTED AND EXPLANTED THE SAME DAY DUE TO A BROKEN HAPTIC, WHICH CAUSED IRIS BLEEDING IN THE LEFT EYE. A REPLACEMENT LENS OF THE SAME MODEL AND DIOPTER WAS THEN IMPLANTED. THERE WAS REPORT OF INCISION ENLARGEMENT THAT NECESSITATED THE USE OF SUTURES. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 22196345 ↗
• InjuryJun 12, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED BY THE CUSTOMER THAT A NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS BEING IMPLANTED AS A REPLACEMENT LENS, HOWEVER IOL WAS EXPLANTED THE SAME DAY AFTER FULL INSERTION DUE TO INSTABILITY AND SINKING. REPORTEDLY, THERE WAS INCISION ENLARGEMENT AND THIS NECESSITATED THE USE OF SUTURES. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 22196184 ↗
• MalfunctionJun 10, 2025Break; Break

  IT WAS REPORTED THAT THE LENS HAD A TORN OR BROKEN HAPTIC. ADDITIONAL INFORMATION REVEALED THAT THERE WAS PATIENT CONTACT, AS THE LENS WAS PARTIALLY INSERTED AND THEN REMOVED DURING THE SAME PROCEDURE. ANOTHER J&J LENS WAS SUCCESSFULLY IMPLANTED WITH NO COMPLICATIONS. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22180579 ↗
• InjuryMar 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE NON PRELOADED INTRAOCULAR LENS (IOL) WAS INSERTED INTO A PATIENT'S EYE BUT WAS SUBSEQUENTLY REMOVED DUE TO THE PATIENT'S ANATOMICAL ISSUE (WEAK CAPSULE, EYE NOT BEING ABLE TO SUPPORT THE LENS AND THE LENS BEGAN TO SINK). UNPLANNED VITRECTOMY WAS PERFORMED. THE SURGEON DID NOT REPLACE THE LENS DURING THE SAME PROCEDURE. IT WAS NOTED THAT THE PATIENT DID NOT EXPERIENCE ANY PERMANENT IMPAIRMENT AND HAD FULLY RECOVERED. THE ISSUE WAS NOT DUE TO USE ERROR. THERE WAS NO DEBILITATING CONDITION IN THE PATIENT. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Capsular Bag Tear

  MAUDE report 21566662 ↗
• MalfunctionSep 4, 2024Break; Break

  IT WAS REPORTED THAT THE HAPTIC OF THE NON PRELOADED INTRAOCULAR LENS (IOL) WAS TORN/BROKEN. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20141488 ↗
• InjuryJul 2, 2024Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A MONOFOCAL INTRAOCULAR LENS (IOL) WAS FULLY INSERTED, BUT PATIENT TO SEE A RETINA SPECIALIST, CANNOT IMPLANT THE LENS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 19662251 ↗
• MalfunctionMay 24, 2024Break; Break

  IT WAS REPORTED THAT DURING THE SURGERY, THE INTRAOCULAR LENS WAS PUSHED INTO THE ANTERIOR CHAMBER, AND THE HAPTIC END WAS LOOSE AND THE JOINT WAS BROKEN AND COULD NOT BE USED. THE INTRAOCULAR LENS WAS IMMEDIATELY REMOVED AND REPLACED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19396566 ↗
• 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 19265149 ↗
• InjuryDec 15, 2023Component Missing; Manufacturing, Packaging or Shipping Problem; Component Missing; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THE SEALED PACKAGING WAS OPEN AND DURING ASSEMBLY THE PACKAGING THAT NORMALLY CONTAINS THE AR40E MODEL INTRAOCULAR LENS (IOL) WAS LOOSE INSIDE THE OUTER PACKAGING (LARGER) AND THERE WAS NO IOL CORRESPONDING TO THE BOX. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A NON-JOHNSON & JOHNSON SURGICAL VISION IOL THAT WAS IMPLANTED INTO THE PATIENT¿S OCULAR SINISTER (LEFT EYE) HOWEVER, THERE WAS A DELAY TO OBTAIN ANOTHER BACK-UP LENS. IT WAS CONFIRMED THAT ADDITIONAL STEPS WERE NECESSARY AS A CONSEQUENCE OF THE SURGERY'S DELAY. PATIENT OUTCOME POST-PROCEDURE WAS REPORTED AS EXCELLENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18336310 ↗
• 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 18321221 ↗
• InjuryJan 30, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE AR40E LENS IS DEFECT, THE TRAILING HAPTIC WAS DETACHED. TROUGH FOLLOW-UP WE LEARNED THAT THE LENS WAS IN THE EYE WHEN THE ISSUE WITH THE DETACHED HAPTIC WAS FOUND AND THE LENS HAD TO BE REMOVED. ANOTHER LENS WAS IMPLANTED WITHOUT ISSUES AND THE REMOVED LENS DISCARDED. THIS WAS ON THE (B)(6) 2023 AND THE PATIENT IS DOING WELL. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16266673 ↗
• InjuryDec 9, 2022Break; Break

  IT WAS REPORTED THAT THERE ARE TWO TECHNO VIGILANCE NOTIFICATIONS. IN BOTH CASES, THE SUPPLIER COLLECTS THE MATERIALS AND SENDS THEM TO THE MANUFACTURER FOR ANALYSIS, AFTER THE ANALYSIS WE RECEIVE THE FEEDBACK. IF IT IS FOUND THAT THERE REALLY WAS A MANUFACTURING DEFECT, THE SUPPLIER SENDS A RETURN NOTE REFERRING TO THE SUPPLIES, GENERATING A CREDIT FOR THE HOSPITAL, "LENS WITH A CRACK". NO OTHER INFORMATION WAS PROVIDED. THIS REPORT CAPTURES EVENT FOR SUSPECT PRODUCT AR40E, SERIAL NUMBER (B)(4). THE OTHER SUSPECT PRODUCT MENTIONED WILL BE CAPTURED IN A SEPARATE REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15955132 ↗
• MalfunctionOct 13, 2022Break; Break

  IT WAS REPORTED THAT THE PATIENT HAD CATARACT SURGERY IN THEIR LEFT EYE, AND THE INTRAOCULAR LENS (IOL) FRACTURED IN THE PATIENT'S EYE DURING IMPLANTATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15602004 ↗
• MalfunctionOct 6, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE HAPTIC OF THE INTRAOCULAR LENS (IOL) TORN OFF OF THE LENS IN THE CARTRIDGE WHEN THE LENS WAS INSERTED INTO PATIENT'S LEFT EYE. THE INCISION WAS ENLARGED AND THE LENS WAS REMOVED. ANOTHER LENS OF SAME MODEL AND DIOPTER WAS USED AS THE REPLACEMENT. NO OTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 15552310 ↗
• MalfunctionJul 18, 2022Break; Break

  IT WAS REPORTED THAT THE LEADING HAPTIC BROKE WHILE THE INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT'S EYE. THE IOL WAS FULLY IMPLANTED AND REMOVED IN THE SAME PROCEDURE. PATIENT WAS PRESCRIBED MAXIDEX AND CIHKA MEDICATIONS WHICH ARE PART OF THE STANDARD OF CARE. SUTURES WERE ALSO PERFORMED AND IT WAS FOR THE INCISION ENLARGEMENT WHICH WAS PART OF THE STANDARD PROCEDURE. THE PATIENT DID NOT SUFFER FROM ANY INJURY AND DID NOT PROVIDE FURTHER FEEDBACK POST SURGERY. THERE WAS NO DELAY IN TREATMENT OR OTHER INTERVENTIONS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 15047769 ↗