SENSAR IOL AR40M (REF AR40M00015)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 05050474514218), received between Dec 19, 2016 and Feb 2, 2026 — classified as 5 injuries, 7 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 2, 2026Break; Ejection Problem

  IT WAS REPORTED BY THE CUSTOMER THAT, DURING IMPLANTATION OF A SENSAR 3-PIECE INTRAOCULAR LENS, THE LENS BECAME STUCK IN THE INJECTOR. UPON WITHDRAWING THE INJECTOR, THE TRAILING HAPTIC WAS FOUND TO BE BROKEN INSIDE THE INJECTOR. THE LENS HAD BEEN PARTIALLY INSERTED AND WAS SUBSEQUENTLY REMOVED DURING THE SAME PROCEDURE. THE PATIENT RECOVERED FULLY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24242832 ↗
• MalfunctionJul 1, 2025Break; Break

  IT WAS REPORTED THAT INTRAOCULAR LENS HAPTIC BROKE AFTER IMPLANTING INTO THE EYE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22379189 ↗
• MalfunctionApr 24, 2023Break; Inaccurate Delivery; Break; Inaccurate Delivery

  IT WAS REPORTED THAT THE NON-PRELOADED INTRAOCULAR LENS (IOL) HAPTIC GOT STUCK IN "SILVER PLUNGER ON INJECTOR, BACK HAPTIC WAS FAULTY." THE IOL WAS FULLY INSERTED IN THE RIGHT EYE AND THEN REMOVED AND REPLACED WITH ANOTHER JOHNSON AND JOHNSON IOL (SAME MODEL AND DIOPTER), DURING THE SAME PROCEDURE. A NEW INJECTOR AND CARTRIDGE WAS USED FOR THE NEW IMPLANTED LENS. THERE WAS NO ISSUE/DAMAGE WITH THE INJECTOR OR CARTRIDGE. THE PROBLEM WAS NOT DUE TO USE ERROR. NO MEDICAL OR SURGICAL INTERVENTIONS WERE REQUIRED AND THERE WAS NO PATIENT INJURY. THE PATIENT OUTCOME WAS GOOD. BALANCED SALT SOLUTION (BSS) WAS USED AND THE TEMPERATURE WAS AT 67/33 HUMIDITY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16795933 ↗
• MalfunctionJul 26, 2022Break; Break

  IT WAS REPORTED THAT THE HAPTIC WAS BENT WHEN INSERTING INTO THE ANTERIOR CHAMBER OF THE PATIENT'S RIGHT EYE. THE INTRAOCULAR LENS (IOL) WAS FULLY INSERTED. IT WAS THEN CUT AND REMOVED. THERE WAS ANOTHER IOL OF SAME MODEL NUMBER AS REPLACEMENT FOR THE PATIENT. THE PATIENT WAS FULLY RECOVERED POST-OP. 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 15107730 ↗
• InjuryDec 5, 2020Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT LEFT EYE CATARACT SURGERY WITH AN INTRAOCULAR LENS IMPLANTED ON (B)(6) 2020. AFTER OPERATION, THE EYES WERE COVERED ROUTINELY. ONE DAY AFTER OPERATION, THE FOLLOW-UP WAS OBSERVED: LEFT EYE: 0.6 -, CONJUNCTIVAL CONGESTION +, CORNEAL EDEMA +, ANTERIOR CHAMBER OFTEN DEEP, TYN (+ +), INTRAOCULAR LENS POSITION WAS POSITIVE, OTHER EXAMINATION CONDITIONS WERE THE SAME AS THOSE IN HOSPITAL. PATIENT HAD INFLAMMATORY REACTION. THE PATIENT WAS PRESCRIBED WITH: PREDNISOLONE ACETATE EYE DROPS, TOBRAMYCIN DEXAMETHASONE EYE DROPS, MOXIFLOXACIN HYDROCHLORIDE EYE DROPS, COMPOUND TROPICAMIDE EYE DROPS, AND AZITHROMYCIN DISPERSIBLE TABLETS 0.5G, WERE GIVEN TO THE LEFT EYE ONCE EVERY HOUR. TOBRAMYCIN DEXAMETHASONE EYE DROPS, MOXIFLOXACIN HYDROCHLORIDE EYE DROPS, COMPOUND TROPICAMIDE EYE DROPS, AND AZITHROMYCIN DISPERSIBLE TABLETS 0.5G, ONCE A DAY. THE SECOND DAY AFTER OPERATION, THE LEFT EYE WAS REEXAMINED: 0.6 +, INTRAOCULAR PRESSURE: 11.7MMHG, THE REST OF THE EXAMINATION CONDITIONS WERE THE SAME AS BEFORE, ALL IMPROVED, THE PATIENT WAS INSTRUCTED TO CONTINUE TO USE THE ABOVE EYE FLUID. PATIENT WAS DISCHARGED. OUTPATIENT REVIEW LAST MONDAY OF THE SURGERY PERIO

  Patient problems: Inflammation

  MAUDE report 10955632 ↗
• MalfunctionJul 14, 2020Break; Break

  IT WAS REPORTED THAT AS A SENSAR MONOFOCAL INTRAOCULAR LENS (IOL) WAS INSERTED INTO THE PATIENT'S LEFT EYE. IT WAS NOTED THAT THE LENS BEGAN TO TEAR AND A PIECE OF THE OPTIC DETACHED. THE SURGEON FINISHED IMPLANTING LENS IN THE SULCUS AND BOTH HAPTICS WERE ROTATED INTO GOOD POSITION. THE PATIENT'S VISUAL ACUITY PRE-OP: 20/25-2. FURTHER INFORMATION WAS PROVIDED AND IT WAS NOTED THAT THE SURGEON HAD DIFFICULTY IN ADVANCING THE LENS, WITH SUDDEN DELIVERY OF THE IOL, AND ABOUT 20-30% APPROXIMATELY OF THE IOL OPTIC WAS TORN. IT WAS REPORTED THE TORN PIECE WAS RECOVERED AND THE LENS REMAINS IMPLANTED. THE SURGEON ALSO MENTIONED THAT DURING POST-OP FINDINGS SUGGEST A MILD UVEITIS GLAUCOMA HYPHEMA (UGH) SYNDROME, BUT STATED NOTHING THAT COULD NOT BE MANAGED AND CURRENT PLAN IS TO PERFORM A LASER IRIDOTOMY IF THE CLINICAL COURSE WARRANTS THE INTERVENTION. THE PATIENT IS CURRENTLY RECOVERING WELL, WITH 20/25 VISION ON THE OPERATED EYE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10274222 ↗
• InjuryJul 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WHILE BEING INSERTED INTO THE EYE HAD A LOADING ISSUE. THE REPORTER WAS NOT SURE IF THERE¿S A HANDLING/ USE ERROR, BUT AN INCISION ENLARGEMENT WAS REQUIRED. IT WAS LEARNED THAT THE PATIENT WAS SUPPOSED TO RECEIVE A MODEL AR40M IOL, BUT AS THIS SUSPECT IOL HAD LOADING ERROR, INSTEAD OF LEAVING THE PATIENT APHAKIC, THE CUSTOMER PUT IN THE SMALLEST DIOPTER LENS THAT THEY HAD IN STOCK, WHICH WAS THE ZCB00 5.0D. THERE WAS NO HARM TO THE PATIENT. THEY PATIENT WAS ACTUALLY VERY HAPPY WITH THE OUTCOME. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10243262 ↗
• InjuryJul 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WHILE BEING INSERTED INTO THE EYE HAD A LOADING ISSUE. THE REPORTER WAS NOT SURE IF THERE¿S A HANDLING/ USE ERROR, BUT AN INCISION ENLARGEMENT WAS REQUIRED. IT WAS LEARNED THAT THE PATIENT WAS SUPPOSED TO RECEIVE A MODEL AR40M IOL, BUT AS THIS SUSPECT IOL HAD LOADING ERROR, INSTEAD OF LEAVING THE PATIENT APHAKIC, THE CUSTOMER PUT IN THE SMALLEST DIOPTER LENS THAT THEY HAD IN STOCK, WHICH WAS A ZCB00 5.0 DIOPTER LENS. THERE WAS NO HARM TO THE PATIENT. THE PATIENT WAS ACTUALLY VERY HAPPY WITH THE OUTCOME. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10243259 ↗
• InjuryJun 21, 2019Break; Break

  IT REPORTED AFTER INSERTING AN AR40M INTRAOCULAR LENS (IOL) INTO THE PATIENT'S OPERATIVE EYE, THE HAPTIC BROKE WHICH RESULTED IN A VITRECTOMY, AND REMOVAL OF THE LENS. THROUGH FOLLOW UP, CUSTOMER ACCOUNT PROVIDED ADDITIONAL INFORMATION STATING A TORN CAPSULAR BAG OCCURRED, VITREOUS PROLAPSE, AND IRIS BLEED WITH BLOOD FALLING INTO THE POSTERIOR CHAMBER (VITREOUS HEMORRHAGE). IT WAS ALSO REPORTED THE INCISION WAS ENLARGED TO ALLOW LENS REMOVAL, POST-OP VISION REPORTED AS POOR, SUTURE(S) WERE REQUIRED, AND THE PATIENT LEFT FACILITY (B)(4). NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: Capsular Bag Tear; Hemorrhage/Blood Loss/Bleeding; Vitrectomy

  MAUDE report 8724805 ↗
• InjuryFeb 14, 2019Unexpected Therapeutic Results; Unexpected Therapeutic Results

  IT WAS REPORTED THAT AN AR40M 1.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2019 DUE TO THE PATIENT HAVING A MYOPIC OUTCOME. THERE WAS NO INCISION ENLARGEMENT AND NO COMPLICATIONS REPORTED. THE REPLACEMENT LENS WAS THE SAME MODEL, BUT DIFFERENT DIOPTER OF 0.5. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8338254 ↗
• MalfunctionNov 6, 2018Failure to Unfold or Unwrap; Material Twisted/Bent; Failure to Unfold or Unwrap; Material Twisted/Bent

  IT WAS REPORTED THAT A AR40M INTRAOCULAR LENS (IOL) WAS FOLDED UPON IMPLANTATION; THE LENS WAS BENT. ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT THE IOL WAS FULLY INSERTED INTO THE PATIENT'S RIGHT EYE AND DID NOT UNFOLD. THE PRODUCT WAS CUT INTO PIECES TO BE REMOVED FROM THE EYE, AND IT WAS DISCARDED BY THE CUSTOMER. ANOTHER IOL OF THE SAME MODEL AND DIOPTER WAS IMPLANTED. THERE WAS NO INJURY AND THE PATIENT WAS REPORTED DOING FINE POST-OP. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8040994 ↗
• MalfunctionDec 19, 2016Break; Break

  IT WAS REPORTED THAT A HAPTIC BROKE OFF FROM AN AR40M INTRAOCULAR LENS (IOL) DURING INSERTION (IN THE MIDDLE OF THE PROCEDURE); THEREFORE, ANOTHER IOL WAS INSERTED. THE INCISION WAS SLIGHTLY ENLARGED. NO SUTURES WERE REQUIRED. THE LENS WAS CUT IN HALF TO REMOVE IT FROM THE EYE. THERE WAS NOT AN ADDITIONAL SURGICAL PROCEDURE SCHEDULED. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Code Available

  MAUDE report 6188097 ↗