SENSAR IOL AR40M (REF AR40M00010)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 05050474501836), received between Sep 29, 2017 and Dec 9, 2025 — classified as 8 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryDec 9, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT INTRAOCULAR LENS (IOL) HAPTIC WAS DISLODGED AND IOL WAS REMOVED. INCISION WAS ENLARGED AND SUTURES WAS REQUIRED. PATIENT CURRENTLY HAVING INTRACRANIAL BLEED, MEDICATION WAS PRESCRIBED. NO FURTHER INFORMATION AVAILABLE.

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

  MAUDE report 23764062 ↗
• MalfunctionNov 7, 2025Break; Break

  IT WAS REPORTED THAT A MONOFOCAL INTRAOCULAR LENS (IOL) WAS DAMAGED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23499071 ↗
• MalfunctionFeb 13, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT THE 3 PIECE MONOFOCAL INTRAOCULAR LENS (IOL) WOULD NOT UNFOLD IN THE EYE. THE SURGEON HAD TO REMOVE THE IOL AND REPLACE IT WITH A BACK UP LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21378370 ↗
• MalfunctionJan 21, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT AFTER IOL WAS IMPLANTED INTO THE EYE, THE IOL HAPTIC LENGTH WAS SUSPECTED TO BE DIFFERENT AS ONE SIDE SEEMS LONGER. HENCE, LENS WAS REMOVED AND CHANGED. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21203159 ↗
• MalfunctionNov 3, 2023Break; Break

  IT WAS REPORTED BY THE CUSTOMER THAT THE NON-PRELOADED MONOCULAR INTRAOCULAR LENS (IOL) HAD THE LENS HAPTIC BENT DURING INSERTION AND THE PHYSICIAN CHOSE TO REMOVE AND PUT IN A BACKUP LENS. THE LENS WAS CUT AND REMOVED DURING THE SAME PROCEDURE AND ANOTHER J&J LENS WITH THE SAME MODEL AND POWER WAS IMPLANTED. PHYSICIAN THINK BECAUSE OF THE COMPLICATED NATURE IN THE LOADING LENS INTO CARTRIDGE LEADS TO HAPTIC DAMAGE. THERE WAS AN INJURY AND MEDICAL AND SURGICAL INTERVENTION  REQUIRED. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 18067486 ↗
• MalfunctionJun 23, 2023Device Difficult to Setup or Prepare; Scratched Material; Device Difficult to Setup or Prepare; Scratched Material

  IT WAS REPORTED THE JOHNSON AND JOHNSON(JNJ) INTRAOCULAR LENS (IOL) WAS TOO THICK FOR THE CARTRIDGE. IT WAS NOTICED TO BE SCRATCHED AFTER IT WAS IMPLANTED IN THE PATIENT¿S RIGHT EYE. THE INCISION WAS ENLARGED AND THE IOL WAS REMOVED AND REPLACED WITH THE SAME MODEL. REPORTEDLY, THERE WERE NO DELAYS IN THE PROCEDURE. THE JNJ OPHTHALMIC VISCOSURGICAL DEVICE (OVD) WAS ALLOWED TO ACCLIMATIZE TO OPERATING ROOM TEMPERATURE. THIS EVENT ENTAILS ONE PATIENT WITH 3 ATTEMPTS. THE FOURTH IOL WAS SUCCESSFULLY IMPLANTED. THEIR TECHNICIAN HAS DECADES OF EXPERIENCE. THE TECHNICIAN FELT THE IOLS WERE ALMOST TOO BIG FOR THE CARTRIDGE. THEREFORE, THE TECHNICIAN WAS APPREHENSIVE TO FOLD IT. THREE DIFFERENT IOLS AND EMERALD CARTRIDGES WERE USED. THE CARTRIDGES WERE FROM THE SAME LOT INCLUDING THE ONE USED TO COMPLETE THE PROCEDURE. THE HANDPIECES WERE FROM DIFFERENT LOTS. THE CUSTOMER MENTIONED THAT THE HANDPIECES WERE SUCCESSFULLY USED IN OTHER CASES. ONLY THIS EVENT HAD PATIENT CONTACT. THROUGH FOLLOW-UP THE CUSTOMER REITERATED THAT THE COMPLAINT IS AGAINST THE IOL. THERE WERE NO ADDITIONAL COMPLICATIONS SUCH AS CAPSULE TEAR, UNPLANNED VITRECTOMY, OR SUTURES. NO MEDICATION OUTSIDE THE STANDARD OF CAR

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

  MAUDE report 17191674 ↗
• InjurySep 7, 2022Break; Inaccurate Delivery; Break; Inaccurate Delivery

  IT WAS REPORTED THAT THE ONE OF THE HAPTIC OF THE INTRAOCULAR LENS (IOL) WAS NOTED TO BE BROKEN DURING IMPLANTATION INTO THE PATIENT'S OPERATIVE EYE. THE LENS WAS PARTIALLY INSERTED AND REMOVED. THE INCISION WAS ENLARGED AND SUTURE WAS PLACED. THERE WAS A DELAY OF 30 MINUTES. THERE WAS NO OTHER INJURY TO THE PATIENT. NO OTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 15374598 ↗
• MalfunctionMay 18, 2022Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS INSERTED INTO PATIENT'S OPERATIVE EYE, HOWEVER, WAS CUT OUT AS THE TRAILING HAPTIC KINKED. ANOTHER LENS WAS SUCCESSFULLY INSERTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14430905 ↗
• InjuryMay 4, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT A AR40M00010 INTRAOCULAR LENS (IOL) WAS REMOVED DUE TO FRACTURE OF THE IOL AT THE TIME OF IMPLANTATION IN PATIENT'S LEFT EYE. THERE WAS A DELAY IN PROCEDURE AND SUTURES WERE USED. NO OTHER INTERVENTIONS REPORTED. THE CUSTOMER OPTED FOR APHAKIA AS THE IOL WAS UNIQUE IN THE DIOPTER AND THE DEGREE WAS LOW (+1.00D). PATIENT WITH STROMAL EDEMA (2+), AND RETINOCHOROIDAL ATROPHY RCA (2+). PATIENT'S DAILY ACTIVITIES WERE SIGNIFICANTLY AFFECTED AND IS PERMANENTLY IMPAIRED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Corneal Edema

  MAUDE report 14274248 ↗
• MalfunctionMay 3, 2022Break; Break

  IT WAS REPORTED THAT THE LENS IS BROKEN PRIOR TO PATIENT CONTACT. THROUGH FOLLOW-UP THE ISSUE WAS CLARIFIED AND HAPTIC DAMAGE OCCURRED DURING THE IMPLANTATION REQUIRED THE LENS REMOVAL AND REPLACEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14270278 ↗
• MalfunctionJan 12, 2022Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS INSERTED AND REMOVED FROM THE PATIENT'S LEFT EYE AS THE SURGEON NOTICED A BROKEN HAPTIC AND PART OF THE LENS (LENS WAS DAMAGED). ANOTHER LENS OF SAME MODEL WAS PLACED AS THE REPLACEMENT DURING THE SAME PROCEDURE WITHOUT ANY ISSUES. ACCOUNT PROVIDED THAT THE LENS WAS POSSIBLY LOADED INCORRECTLY; HOWEVER, THE USER COULD NOT CONFIRM THE STATEMENT. A SUTURE WAS PLACED AS A STANDARD OF CARE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13243191 ↗
• MalfunctionOct 18, 2021Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAD LOADING ISSUE AND THE HAPTIC WAS BENT/ BROKEN. THERE WAS CONTACT WITH PATIENT'S OPERATIVE EYE. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12652166 ↗
• InjuryJul 28, 2020Break; Break

  IT HAS BEEN REPORTED ISSUES WITH AN AR40M. DURING SURGERY, WHEN THE LENS IS INSERTED INTO THE EYE ONCE IT IS LOADED IN THE LENS HOLDER CARTRIDGE, ONE OF THE LEGS REMAINS OUTSIDE THE EYE, AND THE ENTIRE LENS MUST BE REMOVED BECAUSE IT WOULD NOT BE ABLE TO BE FIXED. IN THE EXTRACTION OF THE LENS, THE BODY OF THE LENS IS ALSO BROKEN, SO THAT THE RETURNED LENS HAS BROKEN ONE OF THE LEGS AND THE BODY OF THE LENS. THE LENS COMES INTO CONTACT WITH THE PATIENT'S EYE, IT BREAKS DURING THE INTRODUCTION INTO THE EYE. THE SURGEON REMOVES THE CATARACT BUT ULTIMATELY DOES NOT PLACE ANY LENS BECAUSE THE PATIENT HAS A LOW PRESCRIPTION AND PREFERS TO AVOID FURTHER TRAUMA TO THE EYE. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

  Patient problems: No Code Available

  MAUDE report 10333785 ↗
• InjuryApr 24, 2020Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S OPERATIVE EYE DUE TO BENT HAPTIC. NO OTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9994440 ↗
• InjuryAug 9, 2019Break; Failure to Fold; Break; Failure to Fold

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS DAMAGED DURING FOLDING WITH PARTIAL INSERTION INTO THE EYE. THERE WAS NO VITRECTOMY OR INCISION ENLARGEMENT PERFORMED. SUTURES WERE DONE AS A RESULT OF THE DAMAGED HAPTIC. PATIENT IS DOING GOOD POST-OP. LENS WAS REPLACED WITH A NON J&J LENS. NO OTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8880327 ↗
• MalfunctionMar 18, 2019Break; Break

  IT WAS REPORTED THAT AN AR40M INTRAOCULAR LENS (IOL) WAS NOTICED TO HAVE A KINKED HAPTIC WHEN ADVANCING INTO THE EYE. THERE WAS PATIENT CONTACT WITH THE IOL BUT NO INTERVENTION WAS REQUIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER IOL OF THE SAME MODEL AND DIOPTER. THE PATIENT APPEARED ALRIGHT WHEN DISCHARGED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8429631 ↗
• MalfunctionDec 7, 2018Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE AR40E SENSAR MONOFOCAL IOL (INTRAOCULAR LENS) WAS NOT USED AS THE HAPTIC WAS FAULTY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8141577 ↗
• InjuryOct 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INCISION ENLARGEMENT WAS NEEDED TO BE MADE DURING THE IMPLANTATION OF AN AR40M 1.0 DIOPTER LENS INTO THE PATIENT'S OPERATIVE EYE. THE BARREL OF THE CARTRIDGE WAS REMOVED FROM THE INCISION SITE, INCLUDING THE HALF-WAY INITIATED LENS. A NEW LENS WAS LOADED TO COMPLETE THE SURGERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8008007 ↗
• InjuryMay 3, 2018Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS FOLDED AND INSERTED IN THE ANTERIOR CHAMBER OF THE EYE BUT IT WOULD NOT UNFOLD, SO IT HAD TO BE REMOVED. THE INCISION WAS ENLARGED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON AND JOHNSON SURGICAL VISION, INC.

  Patient problems: No Code Available

  MAUDE report 7482189 ↗
• MalfunctionSep 29, 2017Break; Break

  IT WAS REPORTED THAT THE HAPTIC WAS BROKEN. IT IS UNKNOWN IF THERE WAS PATIENT CONTACT. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Information

  MAUDE report 6905407 ↗