SENSAR IOL AR40e (REF AR40E00150)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 05050474502000), received between Apr 19, 2022 and Sep 14, 2026 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50762796 ↗
• InjuryJun 30, 2026Break

  THE COMPLAINT PERTAINS TO A THREE-PIECE MONOFOCAL NON-PRELOADED INTRAOCULAR LENS (IOL) THAT DID NOT SIT PROPERLY IN THE EYE DURING APPLICATION, WITH THE SURGEON SUSPECTING THAT ONE OF THE HAPTICS MAY HAVE BEEN KINKED OR BENT. THE LENS WAS EXPLANTED, AND THE PATIENT WAS REFERRED TO ANOTHER SURGEON FOR A SECONDARY PROCEDURE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE INTRAOCULAR LENS WAS REMOVED DURING THE SAME PROCEDURE. THERE WAS A 10-MINUTE DELAY IN THE PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25673131 ↗
• MalfunctionApr 10, 2026Material Fragmentation

  IT WAS REPORTED THAT THE HAPTIC OF AN INTRAOCULAR LENS (IOL) BROKE DURING THE INJECTION PROCESS INTO THE PATIENT'S EYE. THE FRACTURED IOL ALONG WITH THE DETACHED HAPTIC WERE REMOVED FROM THE EYE TO ENSURE THE ABSENCE OF ANY LENS REMNANTS. A NEW IOL WAS IMPLANTED, AND THE SURGERY WAS COMPLETED WITHOUT ANY ADDITIONAL REPORTED COMPLICATIONS. THERE WAS NO DELAY IN TREATMENT OR OTHER INTERVENTIONS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24841652 ↗
• MalfunctionMar 13, 2026Break; Material Fragmentation; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS LOADED INTO EMERALD CARTRIDGE AND INSERTED INTO THE PATIENT¿S EYE. THE IOL FELL, SLIPPING TO THE BACK OF THE EYE. DURING RE-POSITIONING THE HAPTIC BECAME BENT AND IT WAS DECIDED TO REMOVE THE LENS. DURING REMOVAL ONE HAPTIC BROKE OFF. THE DOCTOR HAD TO MANIPULATE THE LENS CAREFULLY. NO FOLDING FORCEPS WERE INVOLVED. THEY USED VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE (0.2ML AT ROOM TEMPERATURE) . THE INCISION WAS ENLARGED AND SUTURES WERE USED. REPORTEDLY, IT IS THE DOCTOR¿S STANDARD PRACTICE TO USE SUTURES. THE PATIENT WAS NOT HARMED. THE PROCEDURE WAS COMPLETED WITH A BACKUP LENS OF THE SAME MODEL. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 24596245 ↗
• MalfunctionAug 22, 2025Ejection Problem; Wrong Label; Ejection Problem; Wrong Label

  IT WAS REPORTED THAT THE STANDALONE 3 PIECE MONOFOCAL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE SULCUS WITH THE POSTERIOR OPTIC ORIENTED ANTERIORLY. THE IOL WAS TURNED OVER IN THE EYE AND THE PROCEDURE WAS COMPLETED WITH ONLY A 5 MINUTE DELAY. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTIONS WERE REQUIRED. BOTH THE SCRUB NURSE AND PHYSICIAN INSIST THAT THE DIRECTIONS FOR USE WERE FOLLOWED PRECISELY FOR LOADING THE IOL INTO THE EMERALD UNFOLDER/INSERTER AND DURING IMPLANTATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22877042 ↗
• MalfunctionJul 1, 2025Break; Difficult to Fold, Unfold or Collapse; Break; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT INTRAOCULAR LENS (IOL) HAPTIC BROKE AND IOL COULD NOT UNFOLD IN THE EYE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22379168 ↗
• MalfunctionFeb 20, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) CAME INTO CONTACT WITH THE PATIENT, BUT WHEN IT EXITED THE CARTRIDGE, THE HAPTIC GOT DETACHED. THE LENS WAS SUBSEQUENTLY REMOVED.THROUGH FOLLOW-UP, WE LEARNED THAT THE IOL WAS REMOVED AFTER HAVING ALREADY BEEN INSERTED AND A NEW LENS WAS IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21425907 ↗
• MalfunctionFeb 18, 2025Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS IMPLANTED AND THEN EXTRACTED. ACCOUNT PROVIDED THAT THE HAPTIC WAS BENT. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21403331 ↗
• MalfunctionMay 20, 2024Break; Break

  IT WAS INITIALLY REPORTED THAT THE INTRAOCULAR LENS (IOL) HAD BROKEN HAPTIC, DID NOT IMPLANT. HOWEVER, THROUGH FOLLOW UPS, IT WAS INDICATED THAT THERE WAS A PATIENT CONTACT WHICH THE LENS WAS INSERTED AND REMOVED FROM THE PATIENT'S EYE WHEN BROKEN HAPTIC WAS NOTICED. ANOTHER LENS OF THE SAME MODEL WAS USED. IT WAS CONFIRMED THAT THE CARTRIDGE USED WAS A JOHNSON & JOHNSON CARTRIDGE. THERE WERE NO INTERVENTIONS, NO INJURY AND THE PATIENT OUTCOME STATUS WAS REPORTED TO BE FINE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19352479 ↗
• MalfunctionMar 5, 2024Break; Break

  IT WAS REPORTED DURING IMPLANTATION OF THE AR40E MODEL INTRAOCULAR LENS (IOL), A RUPTURE AT THE EDGE OF THE IOL WAS IDENTIFIED THUS, PREVENTING ITS IMPLANTATION. THE IOL WAS PARTIALLY INSERTED. THE INCISION WAS ENLARGED HOWEVER THERE WERE NO OTHER PROBLEMS WITH THE SURGERY. IT WAS REPORTED SEPARATE IOL FOR WITHDRAWAL AND SPARE IOL WAS USED TO COMPLETE THE PROCEDURE. DEVICE DIRECTIONS FOR USE WERE FOLLOWED. PATIENT STATUS POST-PROCEDURE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18843009 ↗
• MalfunctionApr 19, 2022Break; Inaccurate Delivery; Break; Inaccurate Delivery

  IT WAS REPORTED WHEN SURGEON WAS ADVANCING THE INTRAOCULAR LENS (IOL) HE NOTICED THE TRAILING HAPTIC HAD A KINK, LENS WAS PARTIALLY INSERTED BUT THEN RETRACTED. PATIENT CONTACT WAS CONFIRMED. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS RECEIVED STATING NO UNPLANNED INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY, NO UNPLANNED SUTURE(S), AND NO UNPLANNED VITRECTOMY. THE SAME PROCEDURE WAS COMPLETED USING BACK-UP LENS WITH THE SAME MODEL AND DIOPTER SIZE. PATIENT OUTCOME POST-PROCEDURE WAS REPORTED AS GREAT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14141593 ↗